Phase III study to determine the efficacy of Durvalumab in combination with chemotherapy in completely resected stage II-III non-small cell lung cancer.
- Conditions
- Completely Resected Stage II-III NSCLCMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000556-35-BE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: 1. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using Investigator assessments according to RECIST 1.1 in MRD+ patients.<br>2. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by OS in MRD+ patients and in all patients;Primary end point(s): DFS (using Investigator assessments according to RECIST 1.1) in FAS;Timepoint(s) of evaluation of this end point: Approximately 4 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. DFS (using Investigator assessments according to RECIST 1.1) in<br>MRD+ analysis set.<br>2. OS in MRD+ analysis set and in FAS;Timepoint(s) of evaluation of this end point: Approximately 4 years