NSCLCPhase 2OPTALKNCT06620835
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
A Phase 2 study testing Blood samples for Hematology, Blood samples for Chemistry and Blood sample for liver function tests in people with NSCLC, run by Groupe Francais De Pneumo-Cancerologie at 27 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Blood samples for Hematology, Blood samples for Chemistry and Blood sample for liver function tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 27 sitesFrance
- Study dates
- 19 Jun 2025to 1 Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
France27 sites, 25 recruiting
- Not yet recruiting
CHU de Brest
Brest, 29200
François LUCIA, francois.lucia@chu-brest.fr
- Not yet recruiting
Centre François Baclesse
Caen, 14000
Hubert CURCIO, h.curcio@baclesse.unicancer.fr
- Not yet recruiting
CH Métropole-Savoie
Chambéry, 73000
Julian PINSOLLE, julian.pinsolle@ch-metropole-savoie.fr
- Not yet recruiting
Hôpital Louis Pasteur
Colmar, 68000
Lionel MOREAU, lionel.moreau@ch-colmar.fr
- Not yet recruiting
Pneumologie Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Jean-Bernard AULIAC, jean-bernard.auliac@chicreteil.fr
Jean-Bernard AULIAC
- Not yet recruiting
Centre Georges-François Leclerc
Dijon, 21079
Coureche-Guillaume KADERBHAI, +33 (0)3 80 73 75 28, cgkaderbhai@cgfl.fr
- Not yet recruiting
CH Annecy
Épagny, 74370
Stéphanie HOMINAL, shominal@ch-annecygenevois.fr
- Not yet recruiting
Polyclinique de Blois
La Chaussée-Saint-Victor, 41260
Philippe LAPLAIGE, dr.laplaige@wanadoo.fr
- Not yet recruiting
CHD les Oudaries
La Roche-sur-Yon, 85000
Marie MARCQ, marie.marcq@ght85.fr
- Not yet recruiting
CHU Dupuytren
Limoges, 87042
Yannick SIMONNEAU, yannick.simonneau@chu-limoges.fr
- Withdrawn
Centre Leon Bérard
Lyon, 69373
- Not yet recruiting
Hôpital Nord
Marseille, 13915
Laurent GREILLIER, laurent.GREILLIER@ap-hm.fr
Laurent GREILLIER
- Recruiting
CHRU de Nancy
Nancy, 54000
Bertrand MENNECIER, +33 (0)3 83 15 46 53, b.mennecier@chru-nancy.fr
- Recruiting
CLCC Antoine Lacassagne
Nice, 06189
Victoria FERRARI, +33 (0)4 92 03 12 24, victoria.ferrari@nice.unicacncer.fr
- Not yet recruiting
CHU de Nîmes
Nîmes, 30029
Sylvie VAN HULST, +33 (0)4 66 68 32 21, sylvie.vanhulst@chu-nimes.fr
- Not yet recruiting
CHU Orléans
Orléans, 45067
Yan-Min XU, yan-min.xu@chu-orleans.fr
- Recruiting
Hôpital Tenon
Paris, 75020
Vincent FALLET, +33 (0)1 56 01 62 18, vincent.fallet@aphp.fr
- Withdrawn
CHU de Bordeaux Haut Lévêque
Pessac, 33800
- Not yet recruiting
CHU Rennes, Hôpital Pontchaillou
Rennes, 35000
Thomas GOTER, +33 (0)2 99 28 24 78, thomas.goter@chu-rennes.fr
- Not yet recruiting
CHU Ponchailloux
Rennes, 35033
Thomas GOTER, thomas.goter@chu-rennes.fr
- Not yet recruiting
Hôpital Charles Nicolle
Rouen, 76031
Florian GUISIER, florian.guisier@chu-rouen.fr
Florian GUISIER
- Not yet recruiting
Pneumologie CHU St Etienne
Saint-Etienne, 42270
Sophie BAYLE-BLEUEZ, sophie.bayle@chu-st-etienne.fr
- Not yet recruiting
CHU de la Réunion
Saint-Pierre, 97410
Eric HUCHOT, eric.huchot@chu-reunion.fr
- Not yet recruiting
Centre Paul Strauss
Strasbourg, 67065
Roland SCHOTT, PhD, +33 368766666, rschott@strasbourg@unicancer.fr
Roland SCHOTT, PhD
- Not yet recruiting
HIA St Anne
Toulon, 83800
Olivier Bylicki, bylicki.olivier@yahoo.fr
- Not yet recruiting
CH Bretagne Atlantique
Vannes, 56017
Gonzague DE CHABOT, gonzague.dechabot@ch-bretagne-atlantique.fr
- Not yet recruiting
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, 69655
Lionel FALCHERO, +33 4 74 09 27 23, LFalchero@lhopitalnordouest.fr
Lionel FALCHERO
About this study
Official title: 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)
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.
Read more
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.
- Conditions
- NSCLC
- Being tested
- Blood samples for Hematology, Blood samples for Chemistry, Blood sample for liver function tests, Pregnancy test, Tumour assessment
- Keywords
- NSCLC, Lung cancer, ALK rearrangement, gene mutation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for HematologyBiological
Complete blood count will include erythrocytes, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, leukocytes, hemoglobin, hematocrit.
Blood samples for ChemistryBiological
Clinical chemistry will include serum electrolytes (sodium, potassium, calcium, corrected calcium for hypoalbuminemia), creatinine, CrCl with local formula, and fasting blood glucose.
Blood sample for liver function testsBiological
Laboratory tests to assess liver function will include Aminotransferase Alanine (ALAT), Aminotransferase Aspartate (ASAT), Phosphatase Alkaline (ALP), Gamma-glutamyl Transferase (GGT), total and conjugated bilirubin.
Pregnancy testBiological
Pregnancy test will be performed in women of childbearing potential, including women who have had a tubal ligation. Childbearing potential is defined as not having undergone surgical sterilization, hysterectomy, and/or bilateral oophorectomy or not being postmenopausal (≥12 months of amenorrhea). Urine pregnancy tests will be based on the measurement of β-Human Chorionic Gonadotropin (HCG). If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed at screening.
Tumour assessmentProcedure or surgery
Tumor assessment according to the RECIST v1.1 include the following radiological evaluation: thoracic CT scan, brain MRI or CT scan (MRI is preferred), abdominopelvic scan, PET-CT scan mandatory and at the Investigator's discretion, if needed bone scintigraphy and chest X-ray.
Local Ablative Therapy (LAT)Procedure or surgery
Local Ablative Treatment (LAT) (stereotactic body radiotherapy, surgery, thermal ablation)
| Study group | Role | What they receive |
|---|---|---|
| Clinical Trial population | Experimental | All advanced non-small cell lung cancer (NSCLC) patients 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.
Eligible patients will benefit from local ablative therapy with continuation of brigatinib. Receives: Biological: Blood samples for Hematology; Biological: Blood samples for Chemistry; Biological: Blood sample for liver function tests; Biological: Pregnancy test; Procedure: Tumour assessment; Procedure: Local Ablative Therapy (LAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) centrally assessed
PFS is defined as the time from Brigatinib initiation until tumor progression or death from any cause according to RECIST v1.1, evaluated by the expert panel.
Radiological evaluation of the target lesions(s) will be performed at the following time points: Screening, then every 8 weeks during the first year then every 12 weeks thereafter.
An expert panel of blinded clinicians will anonymously review the radiological evaluations and confirm/infirm the Investigator's assessment. Each Investigator must provide all the documents necessary to assess the various endpoints.
Progression occurring before 2 years will be considered for the endpoint. Patients alive without progression will be censored at the last radiological assessment.
Measured: From the start date of treatment up to the disease progression as per central reading or for a maximum of 3 years.
Secondary outcomes (5)
Progression free survival (PFS) locally assessed
PFS is defined as the time from Brigatinib initiation until tumor progression or death from any cause according to RECIST v1.1, evaluated by the investigators.
Radiological evaluation of the target lesions(s) will be performed at the following time points: Screening, then every 8 weeks during the first year then every 12 weeks thereafter.
If a Computed Tomography (CT) scan for tumor assessment is performed in a Positron Emission Tomography (PET) scanner or CT scanner, the CT acquisition must be consistent with the standards for a full-contrast diagnostic CT scan.
Response will be assessed by the Investigator at each center using RECIST v1.1. Assessments should be performed by the same evaluator, if possible, to ensure internal consistency across visits.
Progression occurring before 2 years will be considered for the endpoint. Patients alive without progression will be censored at the last radiological assessment.
Measured: From the start date of treatment up to the disease progression as per local reading or for a maximum of 3 years.
Overall survival (OS)
Overall survival defined as the time from Brigatinib initiation until death or lost of follow up.
Patients alive will be censored at the date of last news or data cutoff. The patient's status (dead, alive or censored) will be determined at the same time points as PFS (Screening, then every 8 weeks during the first year then every 12 weeks thereafter) in order to evaluate OS. In addition, OS will be determined during the Post-study Follow-up Period via in-person or phone contact every 3 months.
Measured: From the start of treatment until death or lost of follow-up or for a maximum of 3 years
Median PFS
Median PFS defined as the time from Brigatinib initiation until death or lost of follow up.
Patients alive without progressive disease will be censored at the date of last news or data cutoff.
Measured: From the start of treatment until death or lost of follow-up or for a maximum of 3 years
Safety and tolerability
Safety and tolerability : proportion of patients with any adverse event (AE), serious AEs (SAEs) and all AEs of grade ≥3 according to the National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) v5.0 criteria.
Participants will be monitored for AEs from the time the informed consent form is signed until 90 days after the last administration of radiotherapy or until 60 days after the last surgery / thermal ablation. Safety assessments may include monitoring of any or all of the following parameters: clinical symptoms, laboratory, pathological, radiological or surgical findings, results of physical examination, or results of other tests and/or procedures.
Any later SAE, i.e. occurring after the end of the reporting period, which is considered to be related to the trial intervention(s) or to the research (protocol required diagnostic procedures and examinations carried out during the research) must be reported without any limitation in terms of deadline.
Measured: From the enrolment of the participant up to until 90 days after the last administration of radiotherapy or until 60 days after the last surgery / thermal ablation
Duration of Treatment (DOR)
Duration of treatment, defined as the time from the first Brigatinib treatment administration until the date of last treatment administration. Dates of first and last treatment administration will be recorded for each treatment to calculate the duration of treatment.
Measured: From the start date of treatment up to stop date of treatment or for a maximum of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start19 Jun 2025
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Bernard AULIAC, Principal investigator, Centre Hospitalier Intercommunal de Créteil Service PneumologieIsabelle MARTEL LAFAY, Principal investigator, Centre Léon Bérard Service Radiothérapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620835
- Sponsor's protocol ID
- Optalk GFPC 07-2023
- Other IDs
- 2024-A00356-41
- Acronym
- OPTALK
- Status last verified
- Apr 2026
- First submitted
- 27 Sep 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06620835
- Acronym / sponsor ID
- OPTALK / Optalk GFPC 07-2023
- Conditions
- NSCLC
- Keywords
- NSCLC, Lung cancer, ALK rearrangement, gene mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Trial population | Experimental | Biological: Blood samples for Hematology, Biological: Blood samples for Chemistry, Biological: Blood sample for liver function tests, Biological: Pregnancy test, Procedure: Tumour assessment, Procedure: Local Ablative Therapy (LAT)All advanced non-small cell lung cancer (NSCLC) patients 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. Eligible patients will benefit from local ablative therapy with continuation of brigatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for HematologyComplete blood count will include erythrocytes, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, leukocytes, hemoglobin, hematocrit. | Biological | Clinical Trial population |
| Blood samples for ChemistryClinical chemistry will include serum electrolytes (sodium, potassium, calcium, corrected calcium for hypoalbuminemia), creatinine, CrCl with local formula, and fasting blood glucose. | Biological | Clinical Trial population |
| Blood sample for liver function testsLaboratory tests to assess liver function will include Aminotransferase Alanine (ALAT), Aminotransferase Aspartate (ASAT), Phosphatase Alkaline (ALP), Gamma-glutamyl Transferase (GGT), total and conjugated bilirubin. | Biological | Clinical Trial population |
| Pregnancy testPregnancy test will be performed in women of childbearing potential, including women who have had a tubal ligation. Childbearing potential is defined as not having undergone surgical sterilization, hysterectomy, and/or bilateral oophorectomy or not being postmenopausal (≥12 months of amenorrhea). Urine pregnancy tests will be based on the measurement of β-Human Chorionic Gonadotropin (HCG). If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed at screening. | Biological | Clinical Trial population |
| Tumour assessmentTumor assessment according to the RECIST v1.1 include the following radiological evaluation: thoracic CT scan, brain MRI or CT scan (MRI is preferred), abdominopelvic scan, PET-CT scan mandatory and at the Investigator's discretion, if needed bone scintigraphy and chest X-ray. | Procedure or surgery | Clinical Trial population |
| Local Ablative Therapy (LAT)Local Ablative Treatment (LAT) (stereotactic body radiotherapy, surgery, thermal ablation) | Procedure or surgery | Clinical Trial population |
Primary outcome
Progression free survival (PFS) centrally assessed
Time frame: From the start date of treatment up to the disease progression as per central reading or for a maximum of 3 years.
PFS is defined as the time from Brigatinib initiation until tumor progression or death from any cause according to RECIST v1.1, evaluated by the expert panel. Radiological evaluation of the target lesions(s) will be performed at the following time points: Screening, then every 8 weeks during the first year then every 12 weeks thereafter. An expert panel of blinded clinicians will anonymously review the radiological evaluations and confirm/infirm the Investigator's assessment. Each Investigator must provide all the documents necessary to assess the various endpoints. Progression occurring before 2 years will be considered for the endpoint. Patients alive without progression will be censored at the last radiological assessment.
5 secondary outcomes
Progression free survival (PFS) locally assessed
Time frame: From the start date of treatment up to the disease progression as per local reading or for a maximum of 3 years.
Overall survival (OS)
Time frame: From the start of treatment until death or lost of follow-up or for a maximum of 3 years
Median PFS
Time frame: From the start of treatment until death or lost of follow-up or for a maximum of 3 years
Safety and tolerability
Time frame: From the enrolment of the participant up to until 90 days after the last administration of radiotherapy or until 60 days after the last surgery / thermal ablation
Duration of Treatment (DOR)
Time frame: From the start date of treatment up to stop date of treatment or for a maximum of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Bernard AULIAC principal investigator
Centre Hospitalier Intercommunal de Créteil Service Pneumologie
Isabelle MARTEL LAFAY principal investigator
Centre Léon Bérard Service Radiothérapie
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blood samples for Hematology, Blood samples for Chemistry and Blood sample for liver function tests in people with NSCLC, run by Groupe Francais De Pneumo-Cancerologie at 27 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hubert CURCIO (+330231455160, h.curcio@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) centrally assessed (time frame: From the start date of treatment up to the disease progression as per central reading or for a maximum of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.