Clinical Trial Results:
Survival, quality of life and self-reported outcomes of elderly patients with advanced non-small cell lung cancer (NSCLC), treated with pembrolizumab (MK-3475) in the first line setting
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Summary
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EudraCT number |
2016-004353-32 |
Trial protocol |
ES |
Global end of trial date |
28 Apr 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Sep 2023
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First version publication date |
21 Sep 2023
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Other versions |
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Summary report(s) |
Lung Cancer Publication of PEBEL study |
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 |
GECP16/06
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03293680 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundación GECP
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Sponsor organisation address |
Avenida Meridiana, 358, 6a planta, Barcelona, Spain, 08027
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Public contact |
Eva Pereira, Fundación GECP, 34 93 4302006, epereira@gecp.org
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Scientific contact |
Eva Pereira, Fundación GECP, 34 93 4302006, epereira@gecp.org
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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 |
14 Jul 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Apr 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 determine the efficacy, in terms of overall survival at one year, of first-line treatment with Pembrolizumab (MK-3475) in elderly patients with advanced NSCLC expressing PD-L1.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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: 74
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Worldwide total number of subjects |
74
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EEA total number of subjects |
74
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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) |
0
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From 65 to 84 years |
47
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85 years and over |
27
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Recruitment
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Recruitment details |
A total of 83 patients were recruited between February 2018 and November 2019 (the last patient included finished treatment in November 2021) at ten sites in Spain, and 82 patients received treatment. Of these, 74 patients were finally analysed since eight were inclusion errors | ||||||
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Pre-assignment
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Screening details |
Patients with histological or cytological documented stage IIIB or IV squamous and non-squamous NSCLC previously untreated. EGFR and ALK have to be wild-type. Patients must be aged 70 years or more, on day of signing informed consent. Measurable disease (at least 1 lesion) based on RECIST criteria v1.1. PD-L1 expression ≥ 1%. Have a ECOG 0 or 1. | ||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not blinded
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Arms
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Arm title
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Experimental | ||||||
Arm description |
Each subject received 200 mg of intravenous pembrolizumab every three weeks, continued for a maximum of two years or until disease progression, unacceptable toxicity, or patient-consent withdrawal. Pembrolizumab treatment was allowed to continue beyond progression, and up to a maximum of 24 months, if the investigator considered that the clinical benefit to the patient persisted. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Pembrolizumab
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Investigational medicinal product code |
MK-3475
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Each subject received 200 mg of intravenous pembrolizumab every three weeks for a maximum of two years.
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Baseline characteristics reporting groups
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Reporting group title |
Overall study (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
Each subject received 200 mg of intravenous pembrolizumab every three weeks, continued for a maximum of two years or until disease progression, unacceptable toxicity, or patient-consent withdrawal. Pembrolizumab treatment was allowed to continue beyond progression, and up to a maximum of 24 months, if the investigator considered that the clinical benefit to the patient persisted. | ||
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End point title |
Overall Survival [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From the initiation of treatment until end of follow up
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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: We assessed OS, PFS, and DSS with the Kaplan-Meier product-limit method, using the log-rank test to compare curves for independent groups. We calculated two-sided P -values and set the statistical significance level at P ≤ 0.05. We carried out all analyses using R 4.1.2 for Microsoft Windows. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Best response | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From the initiation of study until end of follow up.
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
OS for patients with a PD-L1 under 50% | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From the initiation of treatment until end of follow up
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| No statistical analyses for this end point | |||||||||
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End point title |
OS for patients with a PD-L1 than or equal to 50% | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From the initiation of treatment until end of follow up.
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| No statistical analyses for this end point | |||||||||
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End point title |
Progression Free Survival | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From the initiation of treatment until end of follow up
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Any adverse event or breakdown occurring during the course of the study.
The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 90 days after the last administration of Pembrolizumab.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.0
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Reporting groups
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Reporting group title |
As-treated population
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Reporting group description |
The as-treated population included all patients who received at least one dose of a trial treatment. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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23 Jul 2018 |
Amendment due to the new IB IMP version of the study, the protocol is reviewed and editorial changes are made to some of its points to clarify procedures.
The study schedule is also modified after making these clarifications in the protocol.
The geriatric scales are updated and detected errors are corrected
The procedures for sending samples and the type of samples sent are reviewed with the central laboratory, and it is added that sending cell blocks is allowed. |
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22 Jan 2019 |
Change of Sponsor: The Spanish Lung Cancer Group (GECP), sponsor of the PEBEL study, has recently established the GECP Foundation. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Age-specific issues for complete the study relative to older cancer patients. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/37557022 |
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