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New hope for lung cancer: targeted drug plus local therapy may delay progression

NCT ID NCT06620835

Disease control Sponsor: Groupe Francais De Pneumo-Cancerologie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people with advanced non-small cell lung cancer that has a specific genetic change (ALK rearrangement). Participants take the targeted drug brigatinib, and if their disease shrinks or stabilizes with few remaining tumors, they also receive local treatments like surgery or radiation to destroy those spots. The goal is to see if this combination can keep the cancer from growing longer than brigatinib alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 45 to 50 Gy in 5 fractions), radiofrequency or cryotherapy (=thermoablation) * An Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2. * Life expectancy above 12 weeks as assessed by treating investigator. * Brain metastases at inclusion are allowed if asymptomatic * No history of other malignant tumor during the previous 5 years, except for adequately treated carcinomas (in situ cervical carcinoma, basal cell carcinoma, squamous cell skin carcinoma) and low-grade localized prostate cancer (Gleason \<6). * 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 109/L and/or platelets ≥100 x 109/L, hemoglobin ≥8 g/dL), normal coagulation function (International Normalized Ratio (INR) or prothrombin time ≤1.5 x ULN and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤1.5 x ULN unless the patient is receiving anticoagulant therapy) * For patients of childbearing potential: Women of childbearing potential should use effective non-hormonal contraception during treatment with brigatinib and for at least 4 months following the final dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose of brigatinib. * Signed informed consent to participate in the study * Affiliation with or benefit from French social security Exclusion Criteria: * NSCLC without known ALK rearrangements * Neuroendocrine tumor (even in case of mixed tumors). * Uncontrolled and untreated superior cava syndrome. * Unstable symptomatic brain metastases despite corticosteroid * Leptomeningeal, pericardial, pleural and mesenteric lesions, lymphangitic spread (any tumoral lesions not amenable to definitive local therapy). Peri tumoral lymphangitic spread around a tumor, but limited to a lobe, may be treated by surgery). * Serious concurrent conditions during the previous 6 months (severe or unstable angina pectoris, coronary or peripheral artery bypass graft of \<6 months, class 3 or 4 congestive heart failure, ischemic stroke, grade ≥2 peripheral neuropathy, psychiatric or neurological disorders that may interfere with the patient's understanding of the study or with his/her informed consent. * Severe or non-controlled systemic diseases deemed incompatible with the protocol. * Severe infections within 4 weeks prior to inclusion, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. * Psychological, family, social, or geographical factors that may interfere with the monitoring of the patient as defined by the protocol. * Any protected person (legal person protected by legal protection \[guardianship, tutorship\], person deprived of liberty, pregnant woman, breastfeeding woman, and minor). * Patients who participated in other concomitant studies unless observational and received study therapy or used an investigational device within 4 weeks prior to start of study treatment * Known allergies or adverse reactions to the study drugs * Lung function not compatible with surgery or radiation

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Annecy

    NOT_YET_RECRUITING

    Épagny, 74370, France

  • CH Bretagne Atlantique

    NOT_YET_RECRUITING

    Vannes, 56017, France

  • CH Métropole-Savoie

    NOT_YET_RECRUITING

    Chambéry, 73000, France

  • CHD les Oudaries

    NOT_YET_RECRUITING

    La Roche-sur-Yon, 85000, France

  • CHRU de Nancy

    RECRUITING

    Nancy, 54000, France

  • CHU Dupuytren

    NOT_YET_RECRUITING

    Limoges, 87042, France

  • CHU Orléans

    NOT_YET_RECRUITING

    Orléans, 45067, France

  • CHU Ponchailloux

    NOT_YET_RECRUITING

    Rennes, 35033, France

  • CHU Rennes, Hôpital Pontchaillou

    NOT_YET_RECRUITING

    Rennes, 35000, France

  • CHU de Bordeaux Haut Lévêque

    WITHDRAWN

    Pessac, 33800, France

  • CHU de Brest

    NOT_YET_RECRUITING

    Brest, 29200, France

  • CHU de Nîmes

    NOT_YET_RECRUITING

    Nîmes, 30029, France

  • CHU de la Réunion

    NOT_YET_RECRUITING

    Saint-Pierre, 97410, France

  • CLCC Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre François Baclesse

    NOT_YET_RECRUITING

    Caen, 14000, France

  • Centre Georges-François Leclerc

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Centre Hospitalier de Villefranche sur Saone

    NOT_YET_RECRUITING

    Villefranche-sur-Saône, 69655, France

  • Centre Leon Bérard

    WITHDRAWN

    Lyon, 69373, France

  • Centre Paul Strauss

    NOT_YET_RECRUITING

    Strasbourg, 67065, France

  • HIA St Anne

    NOT_YET_RECRUITING

    Toulon, 83800, France

  • Hôpital Charles Nicolle

    NOT_YET_RECRUITING

    Rouen, 76031, France

  • Hôpital Louis Pasteur

    NOT_YET_RECRUITING

    Colmar, 68000, France

  • Hôpital Nord

    NOT_YET_RECRUITING

    Marseille, 13915, France

  • Hôpital Tenon

    RECRUITING

    Paris, 75020, France

  • Pneumologie CHU St Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42270, France

  • Pneumologie Centre Hospitalier Intercommunal de Créteil

    NOT_YET_RECRUITING

    Créteil, 94010, France

  • Polyclinique de Blois

    NOT_YET_RECRUITING

    La Chaussée-Saint-Victor, 41260, France

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