Clinical Trial Results:
A Phase IIIB, Single Arm Study, of Durvalumab in Combination with Platinum-Etoposide for Untreated Patients with Extensive-Stage Small Cell Lung Cancer reflecting Real World Clinical Practice in Spain (CANTABRICO).
Summary
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EudraCT number |
2020-002328-35 |
Trial protocol |
ES |
Global end of trial date |
21 Jun 2023
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Apr 2025
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First version publication date |
05 Jul 2024
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Other versions |
v1 |
Version creation reason |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D419QC00005
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04712903 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
AstraZeneca
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Sponsor organisation address |
Puerto de Somport 21-23, Madrid, Spain, 28050
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Public contact |
Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
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Scientific contact |
Global Clinical Lead, AstraZeneca, +1 18772409479, information.center@astrazeneca.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Sep 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Jun 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jun 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe safety profile of durvalumab in combination with platinum–etoposide as first-line treatment for patients with ES-SCLC
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Protection of trial subjects |
The patient signed the informed consent before carrying out any procedure related to the study. Physical examination, hematology, biochemistry, ECG and evaluation of the tumor were made before the
inclusion of the patient in the study and during the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Dec 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 101
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Worldwide total number of subjects |
101
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EEA total number of subjects |
101
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
44
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From 65 to 84 years |
57
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85 years and over |
0
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Recruitment
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Recruitment details |
Of the 126 patients included in the study, 25 were screening failures and 101 patients have been analysed. All patients included in the analysis started treatment with chemotherapy and durvalumab and 81 of them started maintenance treatment with durvalumab. | ||||||
Pre-assignment
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Screening details |
All patients that met selection critera and signed the informed consent form were included in the study. | ||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Experimental arm | ||||||
Arm description |
Received study intervention | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Durvalumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
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Baseline characteristics reporting groups
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Reporting group title |
Experimental arm
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Reporting group description |
Received study intervention | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental arm
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Reporting group description |
Received study intervention | ||
Subject analysis set title |
Completed
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Completed the items in the questionnaire.
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Subject analysis set title |
Completed
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Completed the items in the questionnaire.
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Subject analysis set title |
Completed
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Completed the items in the questionnaire.
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Subject analysis set title |
Completed
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Completed the items in the questionnaire.
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Subject analysis set title |
Completed
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Completed the items in the questionnaire.
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Subject analysis set title |
Completed
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Completed the items in the questionnaire.
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Subject analysis set title |
Completed
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Completed the items in the questionnaire.
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End point title |
Number of patients with immune-mediated adverse events (imAE) [1] | ||||||||||
End point description |
Patients with immune-mediated adverse events (imAE) per patient
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End point type |
Primary
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End point timeframe |
During study treatment, until disease progression (median 6 months)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm, descriptive. |
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No statistical analyses for this end point |
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End point title |
Number of patients with adverse events (AEs) grade ≥ 3 [2] | ||||||||||
End point description |
Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
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End point type |
Primary
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End point timeframe |
During study treatment, until disease progression (median 6 months)
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm, descriptive. |
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No statistical analyses for this end point |
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End point title |
Duration of Response (DoR) | ||||||||
End point description |
DoR: Defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.
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End point type |
Secondary
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End point timeframe |
At least every 12 weeks
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No statistical analyses for this end point |
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End point title |
Time to Treatment Discontinuation (TTD) | ||||||||
End point description |
TTD: Defined as the time from the first date of treatment until the end of treatment date.
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End point type |
Secondary
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End point timeframe |
From start of treatment until end of treatment.
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No statistical analyses for this end point |
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End point title |
Overal Survival (OS) | ||||||||
End point description |
OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
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End point type |
Secondary
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End point timeframe |
Every 12 weeks
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No statistical analyses for this end point |
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End point title |
Objective Response Rate (ORR) | ||||||||
End point description |
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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End point type |
Secondary
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End point timeframe |
At least every 12 weeks, up to 18 monts
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No statistical analyses for this end point |
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End point title |
Progression Free Survival (PFS). | ||||||||
End point description |
PFS: Defined as the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment.
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End point type |
Secondary
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End point timeframe |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
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No statistical analyses for this end point |
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End point title |
PFS rate at 6 months | ||||||||
End point description |
Proportion of participants remaining alive without disease progression at 6 months after initiation of study treatment.
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End point type |
Secondary
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End point timeframe |
Every 12 weeks
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No statistical analyses for this end point |
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End point title |
PFS rate at 12 months | ||||||||
End point description |
Proportion of participants remaining alive without disease progression at 12 months after initiation of study treatment.
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End point type |
Secondary
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End point timeframe |
Every 12 weeks
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No statistical analyses for this end point |
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End point title |
DoR rate at 12 months | ||||||||
End point description |
Proportion of responders remaining alive without disease progression at 12 months after first response.
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End point type |
Secondary
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End point timeframe |
Every 12 weeks
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No statistical analyses for this end point |
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End point title |
OS rate at 6 months | ||||||||
End point description |
Proportion of participants remaining alive at 6 months after initiation of study treatment.
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End point type |
Secondary
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End point timeframe |
Every 12 weeks
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No statistical analyses for this end point |
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End point title |
OS rate at 12 months | ||||||||
End point description |
Proportion of participants remaining alive at 12 months after initiation of study treatment.
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End point type |
Secondary
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End point timeframe |
Every 12 weeks
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No statistical analyses for this end point |
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End point title |
OS rate at 18 months | ||||||||
End point description |
Proportion of participants remaining alive at 18 months after initiation of study treatment.
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End point type |
Secondary
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End point timeframe |
Every 12 weeks
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Global Health Status, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Physical Functioning, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Role Functioning, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Cognitive Functioning, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Emotional Functioning, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Social Functioning, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Insomnia, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Dyspnea, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Nausea, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Pain, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Fatigue, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Appetite loss, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
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End point type |
Secondary
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End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
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No statistical analyses for this end point |
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End point title |
QLQ-C30: Constipation, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-C30: Diarrhea, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-C30: Financial difficulties, change from baseline | ||||||||
End point description |
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Cough, change from baseline | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Haemoptysis, change from baseline | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Dyspnea, change from baseline | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Pain in arm or shoulder, change from baseline | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Dysphagia | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Alopecia | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Neuropathy | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Sore mouth | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Other Pain, change from baseline | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
QLQ-LC13: Chest pain | ||||||||
End point description |
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (cycle 1 day 1) and end of treatment visit.
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
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Adverse events information
|
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Timeframe for reporting adverse events |
18 months
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
|
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Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Experimental arm
|
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Reporting group description |
Received study intervention | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
02 Feb 2021 |
Addition of two biomarker substudies. Additional blood sampling at baseline and every 2 cycles until cycle 8 and a fresh tumor biopsy at disease progression. Updated inclusion criterion 4B in order to allow participation in the study of patients with brain metastases treated with steroids and anticonvulsants. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |