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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Hubert CURCIO contact

+330231455160

h.curcio@baclesse.unicancer.fr

Soizic FERLANDIN contact

+330663224789

soizic_ferlandin@yahoo.fr

27 sites in 1 country

France27 sites, 25 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

    Not yet recruiting

  • Centre Leon Bérard

    Lyon, 69373

    Withdrawn

  • Hôpital Nord

    Marseille, 13915

    Laurent GREILLIER, laurent.GREILLIER@ap-hm.fr

    Laurent GREILLIER

    Not yet 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

    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

    Not yet recruiting

  • Hôpital Tenon

    Paris, 75020

    Vincent FALLET, +33 (0)1 56 01 62 18, vincent.fallet@aphp.fr

    Recruiting

  • CHU de Bordeaux Haut Lévêque

    Pessac, 33800

    Withdrawn

  • 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

    Not yet recruiting

Other trials in France

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 groups in NCT06620835
Study groupRoleWhat they receive
Clinical Trial populationExperimentalAll 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.

  1. 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)

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted1 Oct 2024
  2. Study start19 Jun 2025
  3. Primary completion1 Oct 2030 (estimated)
  4. Study completion1 Oct 2030 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT06620835.

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.

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