Study Comparing AZD9291 and Placebo in Patients with Stage IB-IIIA Non-Small Cell Lung Cancer After Tumor Removal

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT02511106

Provider View

This clinical trial is testing the effectiveness and safety of the drug AZD9291 compared to a placebo in patients with certain types of non-small cell lung cancer (NSCLC) who have had their tumors completely removed, with or without additional chemotherapy.

Patient Parameters

Program Overview

The study aims to evaluate how well AZD9291 works and how safe it is for patients with stage IB-IIIA non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. These patients have had their tumors completely removed through surgery and may or may not have received additional chemotherapy afterward. The trial will compare AZD9291 to a placebo to see which is more effective in preventing cancer from returning.

Description

This is a phase 3 study where neither the patients nor the researchers know who is receiving AZD9291 or a placebo. It involves patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who have specific mutations in the EGFR gene, which are known to respond to certain treatments. These patients have had their tumors completely removed through surgery and may have received additional chemotherapy. The chemotherapy, if given, should have been a platinum-based treatment for up to four cycles. The study will help determine if AZD9291 is more effective than a placebo in preventing cancer recurrence.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) with specific characteristics.
  • Must have had a brain scan (MRI or CT) before surgery.
  • Cancer must be classified as Stage IB, II, or IIIA after surgery.
  • Tumor must have specific EGFR mutations that respond to treatment.
  • Must have had complete surgical removal of the lung cancer.
  • Must have fully recovered from surgery and any additional therapy.
  • Must have a good performance status, meaning able to carry out daily activities with little or no assistance.
  • Female patients must use effective birth control, not be breastfeeding, and have a negative pregnancy test before starting the study, or must be unable to have children.

Exclusion Criteria

  • Have received or plan to receive radiation therapy for the current lung cancer.
  • Have had chemotherapy before or after surgery for the current lung cancer.
  • Have had any previous cancer treatments.
  • Have had major surgery within four weeks before starting the study drug.
  • Are taking certain medications or supplements that affect how the body processes drugs.
  • Have had only limited types of lung surgery, like segmentectomies or wedge resections.
  • Have a history of other cancers, unless they were treated and have been cancer-free for over five years.
  • Have unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
  • Have uncontrolled health conditions, such as high blood pressure or active infections.
  • Have digestive issues that prevent taking the study drug.
  • Have heart conditions that affect the heart's rhythm or electrical activity.
  • Have a history of lung diseases like interstitial lung disease (ILD) or radiation pneumonitis.
  • Have inadequate bone marrow or organ function.

Locations

FACILITYZIPCITYSTATE
Research Site90048Los AngelesCalifornia
Research Site90404Santa MonicaCalifornia
Research Site95403Santa RosaCalifornia
Research Site90505TorranceCalifornia
Research Site81501Grand JunctionColorado
Research Site06520New HavenConnecticut
Research Site06856NorwalkConnecticut
Research Site33901Fort MyersFlorida
Research Site33028Pembroke PinesFlorida
Research Site33705St. PetersburgFlorida

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