Study on Lorlatinib and Local Therapy for ALK Positive Advanced Non-Small Cell Lung Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07415005

Provider View

This clinical trial is testing the effectiveness of the drug lorlatinib, alone and in combination with local therapy, in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not previously received certain treatments.

Patient Parameters

Program Overview

This study is for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called ALK rearrangement. Participants will first receive the drug lorlatinib for 12 weeks. The study aims to compare how well patients do on lorlatinib alone versus lorlatinib combined with local treatments like surgery or radiation. Researchers will also look at the safety of these treatments and how they affect overall survival and cancer progression.

Description

The main goal of this study is to see if adding local treatments to lorlatinib can help patients with ALK-positive NSCLC live longer without their cancer getting worse. Researchers will also check the safety of these treatments and try to include more patients from underserved communities. They will study how long patients live overall and how long it takes for cancer to progress in areas not treated with local therapy. Additionally, the study will explore if certain blood tests can predict how well patients respond to treatment and if local therapy affects resistance to lorlatinib.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV or recurrent non-small cell lung cancer (NSCLC) that cannot be treated with surgery or other combined treatments.
  • Have a confirmed ALK rearrangement through specific tests.
  • Have not received tyrosine kinase inhibitors (TKIs) before or have been on lorlatinib for 12 weeks without cancer progression.
  • Eligible for local consolidation therapy according to the doctor.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Be 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 birth control during the study and for 4 months after.
  • Men must agree to use effective birth control during the study and for 4 months after.
  • Have a normal heart rhythm as shown by an ECG.
  • Agree to provide written informed consent and follow study procedures.

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 ALK-targeted TKI, except as specified in the inclusion criteria.
  • Have received more than one cycle of chemotherapy or immunotherapy for advanced cancer.
  • Have symptomatic brain metastases or need increasing doses of steroids for brain disease.
  • Have spinal cord compression or certain lung diseases.
  • Have allergies to lorlatinib or its ingredients.
  • Have digestive issues affecting drug absorption.
  • Have uncontrolled high blood pressure.
  • Have had radiation therapy within 14 days before starting the study, except for certain types.
  • 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 taking other cancer treatments during the study.
  • Have a history of allergic reactions to similar drugs.
  • Have HIV infection.
  • Are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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