MedTrace Logo

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

NCT02511106 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2026-03-30

Study results available
· View outcomes & findings →

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

Conditions

  • Stage IB-IIIA Non-small Cell Lung Carcinoma

Interventions

DRUG

AZD9291 80 mg/40 mg

The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.

DRUG

Placebo AZD9291 80 mg/40 mg

The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.

DRUG

Open-label AZD9291 80 mg/40 mg

Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-21
Primary Completion
2022-04-11
Completion
2029-01-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02511106 on ClinicalTrials.gov