Phase III study to determine the efficacy of Durvalumab in combination with chemotherapy in completely resected stage II-III non-small cell lung cancer.

Phase 1

• Conditions: Completely Resected Stage II-III NSCLC; MedDRA 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-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-12
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 332

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 232
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified