What is Brigatinib studying for advanced NSCLC with ALK rearrangement?

Brigatinib is being studied to see if combining it with local ablative therapy (LAT) at the time when Brigatinib works best can improve treatment outcomes for people with advanced non-small cell lung cancer (NSCLC) that has an ALK gene change. The study is led by Groupe Francais De Pneumo-Cancerologie and aims to find better ways to manage this cancer type.

Who may be eligible for this NSCLC clinical trial?

Adults aged 18 years or older with advanced NSCLC confirmed to have an ALK gene rearrangement and who have not been treated with Tyrosine Kinase Inhibitors before may be eligible. Participants need to have stable disease or tumor response after Brigatinib treatment and limited metastatic lesions suitable for local ablative therapy. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this NSCLC clinical trial?

Study-related care, including Brigatinib treatment, local ablative therapy, and all trial visits, is provided at no cost. However, personal travel expenses to attend clinic visits or procedures may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06620835

Optimization of Treatment With Brigatinib in Patients With Advanced NSCLC Harboring an ALK Rearrangement by LAT at the Time of Best Response A Multicenter Open Phase Two Trial OPTALK

Led by Groupe Francais De Pneumo-Cancerologie · Updated on 2026-04-29

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This trial investigates whether giving systemic Brigatinib along with local ablative therapy LAT at the time when Brigatinib is working best can improve outcomes for adults with advanced non-small cell lung cancer NSCLC that has an ALK gene rearrangement. This type of alteration leads to abnormal proteins causing cancer cells to multiply. The study involves participants whose cancer has responded or stabilized after 3 to 9 months of Brigatinib treatment and who have a limited number of metastatic lesions suitable for LAT. Participants who meet criteria will receive LAT such as surgery, stereotactic radiosurgery SRS, or percutaneous thermal ablation for liver or adrenal metastases, while continuing Brigatinib. The disease status will be evaluated between 3 to 9 months after starting Brigatinib to confirm tumor response or stabilization and check that all tumor targets are accessible to LAT as reviewed by an expert panel. During the study, participants will visit the clinic for eligibility assessment prior to LAT, receive LAT, then undergo regular check-ups every 8 weeks for the first year after LAT and every 12 weeks thereafter, for up to 3 years. Researchers will monitor progression-free survival and overall survival, along with safety and treatment duration. Assessments include imaging scans, laboratory blood tests, and pregnancy tests for women of childbearing potential.

CONDITIONS

Brief Title

Trial for Local Ablative Treatment (LAT) Optimization in Patients With Advanced Non-Small Cells Lung Cancer (NSCLC) Presenting an Anaplastic Lymphoma Kinase (ALK) Rearrangement Treated by Brigatinib

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at diagnosis
Stage 3 NSCLC not eligible for chemoradiotherapy or stage 4 NSCLC confirmed by tissue or cytology
No prior treatment with Tyrosine Kinase Inhibitors
ALK rearrangements confirmed by validated testing methods
Stable disease or response after 3 to 9 months of Brigatinib treatment
At least one residual tumor site suitable for local ablative therapy
Oligometastatic disease with five or fewer metastatic lesions and no more than two lesions per organ
Eligible for local ablative treatments such as surgery, stereotactic radiosurgery, radiotherapy, radiofrequency, or cryotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Life expectancy greater than 12 weeks
Brain metastases allowed if asymptomatic
No other malignant tumors in the past 5 years except certain treated carcinomas
Adequate organ function as shown by laboratory tests
Women of childbearing potential must use effective contraception during and after treatment
Signed informed consent
Affiliated with or beneficiary of French social security

You will not qualify if you...

NSCLC without known ALK rearrangements
Neuroendocrine tumors
Uncontrolled or untreated superior vena cava syndrome
Unstable symptomatic brain metastases despite corticosteroid treatment
Lesions not suitable for local therapy such as leptomeningeal, pericardial, pleural, mesenteric, or lymphangitic spread
Serious concurrent health conditions in past 6 months including severe heart disease, stroke, or grade 2 or higher peripheral neuropathy
Psychiatric or neurological disorders interfering with study understanding or consent
Severe or uncontrolled systemic diseases
Severe infections within 4 weeks prior to inclusion
Psychological, social, or geographical factors that might interfere with monitoring
Protected persons such as those under legal guardianship, pregnant or breastfeeding women, and minors
Participation in other interventional studies within 4 weeks prior to study treatment
Known allergies or adverse reactions to study drugs
Lung function unsuitable for surgery or radiation therapy

Research Team

Hubert CURCIO

Soizic FERLANDIN

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