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New treatment option for NSCLC
Official title 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
ClinicalTrials.gov ID: NCT06620835
What this study is testing
What is Blood samples for Hematology?
Blood samples for Hematology is an investigational medicine, being studied as a potential treatment for nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Stable disease or response after initiation brigatinib treatment (at least 3 to 9 months) according to RECIST 1.1
You likely can't join if
- 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...
- Serious concurrent conditions during the previous 6 months (severe or unstable angina pectoris, coronary or peripheral artery bypass graft of \<6...
See the full eligibility 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...
- 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...
- 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...
- 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...
- Signed informed consent to participate in the study
- Affiliation with or benefit from French social security
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Caen, France
- Chambéry, France
- Colmar, France
- Créteil, France
- Dijon, France
- Épagny, France
- La Chaussée-Saint-Victor, France
- La Roche-sur-Yon, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nancy, France
- Nice, France
- Nîmes, France
- Orléans, France
- Paris, France
- Pessac, France
- Rennes, France
- Rouen, France
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Caen, France; Chambéry, France; Colmar, France; Créteil, France; Dijon, France and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.