Study on Brigatinib with Chemotherapy or Local Therapy for ALK Positive Advanced Non-Small Cell Lung Cancer (BrightStar-2)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06522360

Provider View

This clinical trial is exploring whether combining the drug brigatinib with either local treatments like surgery or radiation, or with chemotherapy, can better control advanced non-small cell lung cancer (NSCLC) that is ALK positive, compared to using brigatinib alone. The study will also look at the safety of these combinations.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding local treatments (like surgery or radiation) or chemotherapy to brigatinib can help control ALK positive advanced non-small cell lung cancer (NSCLC) better than brigatinib alone. Researchers will also study the safety of these treatment combinations and aim to include more participants from underserved populations. The study will measure how long patients live without the cancer getting worse and overall survival rates.

Description

This study is designed to compare the effectiveness of brigatinib alone versus brigatinib combined with either local consolidation therapy (LCT) or chemotherapy in patients with ALK positive advanced non-small cell lung cancer (NSCLC). The main goals are to see if these combinations can improve the 2-year progression-free survival (PFS) rate and overall survival (OS) compared to brigatinib alone. The study will also assess the safety and tolerability of these treatments.

Participants will be divided into groups to receive either brigatinib alone, brigatinib with LCT, or brigatinib with chemotherapy. The study will track how long it takes for the cancer to progress in areas not treated with LCT in the brigatinib plus LCT group. Researchers aim to increase trial enrollment among underserved populations to ensure diverse participation.

The study will also evaluate the time it takes for the cancer to progress in areas not treated with LCT in the brigatinib plus LCT group. Participants will be monitored for side effects and overall health throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV non-small cell lung cancer (NSCLC) or recurrent NSCLC that cannot be treated with surgery or radiation alone.
  • Cancer must have a specific ALK gene rearrangement, confirmed by certain lab tests.
  • Can join the study if you have not had any tyrosine kinase inhibitor (TKI) treatment, or if you have been on brigatinib for up to 12 weeks without the cancer getting worse, or if you have been on alectinib, lorlatinib, or ensartinib for 4 weeks without progression and then switch to brigatinib.
  • Suitable for local consolidation therapy according to your doctor.
  • ECOG performance status of 0 to 2, meaning you are fully active or have some restrictions but can still do light work.
  • Aged 18 years or older.
  • Have adequate organ function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after the last dose.
  • Men must agree to use effective contraception during the study and for 4 months after the last dose.
  • Normal heart rhythm as shown by an ECG.
  • Willing to provide written informed consent and comply with study requirements.

Exclusion Criteria

  • Have another type of cancer, except for certain skin or cervical cancers, or prostate cancer treated more than 2 years ago.
  • Have received any prior TKI treatment, except as specified in the inclusion criteria.
  • Have had more than one cycle of chemotherapy for advanced cancer.
  • Have symptomatic brain metastases or need increasing doses of steroids for brain disease.
  • Have spinal cord compression or untreated brain disease.
  • Have lung diseases like interstitial disease or pneumonitis.
  • Have allergies to brigatinib or its ingredients.
  • Have digestive issues that affect drug absorption.
  • Have uncontrolled high blood pressure.
  • Have had radiation therapy within 14 days before starting the study, except for certain types of targeted radiation.
  • Have had major surgery within 30 days before starting the study.
  • Have significant heart disease or recent heart attack.
  • Have had a stroke within 6 months before starting the study.
  • Have an active infection requiring IV antibiotics.
  • Are pregnant or breastfeeding, due to potential risks to the baby.

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