NCT06620835 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
| NCT ID | NCT06620835 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Groupe Francais De Pneumo-Cancerologie |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2030-10-01 |
Trial Parameters
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Brief Summary
The goal of this clinical trial is to learn if the treatment by systemic Brigatinib (ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if administered when the brigatinib works best in participants presenting an advanced non-small cells lung cancer with an ALK gene anomaly (this anomaly produces a defective protein that is responsible for the multiplication of cancer cells). This clinical trial is expected to involve 45 participants in several sites in France. Advanced non-small cell lung cancer (NSCLC) participants with ALK rearrangements treated with brigatinib in first line of non-curable setting will be screened. If the disease assessment done between 3 to 9 months after initiation of brigatinib shows: * a tumor response or stabilization (according to RECIST 1.1) * a disease which meets the definition of an oligometastatic disease (five metastatic lesions or less and a maximum of two lesions per organ) * all tumor targets are accessible to a local ablative therapy (confirmed by an expert panel of clinicians before inclusion): surgery, stereotactic radiosurgery (SRS). For liver, adrenal, or other metastases, percutaneous thermal ablation will be accepted. Participants will be asked to visit the clinic: * for eligibility criteria assessment prior to LAT * for LAT * every 8 weeks for checkups and tests the first year after LAT * and then every 12 weeks, for a maximum period of 3 years. Eligible patients will benefit from local ablative therapy with continuation of brigatinib.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older at diagnosis. * Stage 3 non eligible for chemoradiotherapy or stage 4 NSCLC, histologically or cytologically confirmed NSCLC. * Tyrosine Kinase Inhibitor (TKI) treatment naïve. * ALK rearrangements identified by a validated technique (either Immunohistochimy (IHC), fluorescence in situ hybridization (FISH) or Ribonucleic Acid (RNA)seq, in tissue or liquid biopsy) * Stable disease or response after initiation brigatinib treatment (at least 3 to 9 months) according to RECIST 1.1 * At least one site of residual site for LAT (ie. participant should not have a complete response) * Oligometastatic disease (five metastatic lesions or less and a maximum of two lesions per organ) de novo or induced * Eligible for local ablative treatment possible (either alone or combined): surgery, minimally invasive form of surgical radiosurgery (Stereotactic Radio Surgery (SRS)) (18 to 20 Gy in single fraction) or radiotherapy (SBRT) (27 to 54 Gy in 3 fractions or