E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Completely Resected Stage II-III NSCLC |
|
E.1.1.1 | Medical condition in easily understood language |
Specific type of lung cancer called “Non-Small Cell Lung Cancer” at specific stage (stage II/III) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in MRD+ patients |
|
E.2.2 | Secondary objectives of the trial |
1. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in all patients
2. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC
chemotherapy as measured by DFS using BICR assessments according to RECIST 1.1 in MRD+ patients and in all patients
3. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC
chemotherapy as measured by OS in MRD+ patients and in all patients
4. To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with
durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy
5. To assess the PK of durvalumab
6. To investigate the immunogenicity of durvalumab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Capable of giving signed informed consent, which includes a mandatory
genetic informed consent and compliance with the requirements and restrictions listed in the
informed consent forms (ICFs) and study protocol
2. Age ≥18 years at the time of screening
3. Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease
4. Complete resection of the primary NSCLC |
|
E.4 | Principal exclusion criteria |
1. Postoperative imaging demonstrating unequivocal evidence of disease recurrence or
tissue biopsy-proven disease recurrence
2. EGFR-mutant and/or ALK-translocation
3. Mixed small cell and NSCLC histology
4. Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab |
|
E.5 End points |
E.5.1 | Primary end point(s) |
DFS in MRD+ analysis set (using Investigator assessments according to RECIST 1.1) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. DFS in FAS (using Investigator assessments according to RECIST 1.1)
2. DFS (using BICR assessments according to RECIST 1.1) in MRD+ analysis set and in FAS
3. OS in MRD+ analysis set and in FAS
4. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13
5.Concentration of durvalumab
6. Presence of ADAs for durvalumab |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 79 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Brazil |
Bulgaria |
Canada |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
India |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
Peru |
Poland |
Romania |
Russian Federation |
Spain |
Sweden |
Switzerland |
Taiwan |
Thailand |
Turkey |
United Kingdom |
United States |
Vietnam |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of study is defined as the last expected visit/contact of the last patient undergoing the
study. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |