Clinical Trial: NCT02511106
AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-09-11 |
Study Overview
Brief Summary
To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy
Official Title
A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).
Conditions
Stage IB-IIIA Non-small Cell Lung Carcinoma
Intervention / Treatment
- Drug: AZD9291 80 mg/40 mg
- Drug: Placebo AZD9291 80 mg/40 mg
- Drug: Open-label AZD9291 80 mg/40 mg
Other Study ID Numbers
- D5164C00001
- 2023-506524-82-00
- 2015-000662-65
- 2015
- 2023
Start Date (Actual)
2015-10-21
Primary Completion Date (Actual)
2022-04-11
Study Completion Date (Estimated)
2029-01-31
Enrollment (Actual)
682
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-09-11 |
Study Overview
Brief Summary
To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy
Official Title
A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).
Conditions
Stage IB-IIIA Non-small Cell Lung Carcinoma
Intervention / Treatment
- Drug: AZD9291 80 mg/40 mg
- Drug: Placebo AZD9291 80 mg/40 mg
- Drug: Open-label AZD9291 80 mg/40 mg
Other Study ID Numbers
- D5164C00001
- 2023-506524-82-00
- 2015-000662-65
- 2015
- 2023
Start Date (Actual)
2015-10-21
Primary Completion Date (Actual)
2022-04-11
Study Completion Date (Estimated)
2029-01-31
Enrollment (Actual)
682
Study Type
Interventional
Phase
Phase 3