Phase III study to evaluate the efficacy and safety of durvalumab compared to placebo in patients with NSCLC who have minimal residual disease after surgery +/- additional therapy before or after surgery.

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: EUCTR2020-000612-30-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-18
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 284

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

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;

Study & Design

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