OncoMatch/Clinical Trials/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
Is NCT06620835 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Blood samples for Hematology and Blood samples for Chemistry for nsclc.
Treatment: Blood samples for Hematology · Blood samples for Chemistry · Blood sample for liver function tests · Pregnancy test — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK rearrangement
Disease stage
Required: Stage III, IV
Stage 3 non eligible for chemoradiotherapy or stage 4 NSCLC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
absolute neutrophil count ≥1.5 x 10^9/L and/or platelets ≥100 x 10^9/L, hemoglobin ≥8 g/dL
Kidney function
calculated creatinine clearance above 45 ml/mn
Liver function
bilirubin ≤1.5 x ULN, ALT and AST ≤2.5 x ULN or ≤5 x ULN in case of liver metastases
Adequate organ function, as demonstrated by laboratory results prior to the first administration of study treatment: normal hepatic function (bilirubin ≤1.5 x upper limit of normal (ULN), alanine aminotransferase (ALA T) and aspartate aminotransferase (ASAT) ≤2.5 x ULN or ≤5 x ULN in case of liver metastases), renal function (calculated creatinine clearance (CrCl, using local formula) above 45 ml/mn), normal hematological function (absolute neutrophil count ≥1.5 x 10^9/L and/or platelets ≥100 x 10^9/L, hemoglobin ≥8 g/dL), normal coagulation function (INR or prothrombin time ≤1.5 x ULN and aPTT or PTT ≤1.5 x ULN unless the patient is receiving anticoagulant therapy)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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