Completely resected stage II-III NSCLC MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: 1.EGFR and/or ALK mutant as assessed either from the tumor biopsy taken prior to surgery or the resected tumor tissue. Testing must be performed using a well-validated, local regulatory approved test; 2.Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who perform lung cancer surgery as a significant part of their practice; 3.History of allogeneic organ or bone marrow transplantation; 4.Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of durvalumab compared to placebo as measured by DFS (using Investigator assessment according to RECIST 1.1.) in the PD-L1 TC=1% analysis set;Secondary Objective: 1.To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients (using investigator assessment according to RECIST 1.1); 2.To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC=1% analysis set and in all randomized patients (using BICR assessment according to RECIST 1.1); 3.To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes; 4.To assess the efficacy of durvalumab compared to placebo as measured by OS in the PD-L1 TC=1% analysis set and in all randomized patients; 5.To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo; 6.To investigate the relationship between a patient’s baseline PD-L1 TC expression and efficacy of study treatments;Primary end point(s): DFS in PD-L1 TC=1% (using Investigator assessments according to RECIST 1.1);Timepoint(s) of evaluation of this end point: Approximately 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 PD-L1 TC=1% and in FAS 3. PFS (using local standard practice) 4. Time to first subsequent therapy (TFST) 5. Time to second subsequent therapy (TSST) 6. OS in PD-L1 TC=1% and in FAS 7. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13 8. IHC analysis of PD-L1 TC expression and spatial distribution within the tumor microenvironment relative to efficacy outcomes (ie, DFS, OS);Timepoint(s) of evaluation of this end point: Approximately 5 years | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Netherlands, Peru, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactInformation Center
Astra Zeneca
Outcome results
None listed