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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 (Jun 2026). This Phase 2 trial studies multiple treatments including Blood samples for Hematology and Blood samples for Chemistry for nsclc.

Phase 2RecruitingGroupe Francais De Pneumo-CancerologieNCT06620835Data as of Jun 2026Location: France

Treatment: Blood samples for Hematology · Blood samples for Chemistry · Blood sample for liver function tests · Pregnancy testThe 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.

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Extracted eligibility criteria

Treatments studied

Other

Blood samples for HematologyBlood samples for ChemistryBlood sample for liver function testsPregnancy test

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

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Frequently asked questions

Is NCT06620835 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ALK?

Yes, ALK rearrangement is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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