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Tests treatment safety and results for NSCLC Stage IV
Official title Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC
ClinicalTrials.gov ID: NCT06552234
What this study is testing
What is Repotrectinib?
Repotrectinib is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for nsclc stage iv.
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
- ROS1 rearrangements are rare, accounting for only 1-2% of NSCLC cases, but have been associated with response to ROS1 inhibitors, such as crizotinib and entrectinib. However, many patients develop resistance to the tyrosine-kinase inhibitors (TKIs), creating a need for new treatments.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Eligible patients are defined as patients with
- Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 at the time of inclusion and/or
- Age ≥ 70 years
- Age ≥ 18 years
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an ROS1 gene rearrangement as by any nucleic...
You likely can't join if
- Malignancies other than NSCLC within 2 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g...
- Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis...
- Active tuberculosis
- Severe infections within 2 weeks prior to inclusion, including, but not limited to, hospitalization for complications of infection, bacteremia, or...
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or...
- Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the...
See the full eligibility criteria
Who can join
- Eligible patients are defined as patients with
- Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 at the time of inclusion and/or
- Age ≥ 70 years
- Age ≥ 18 years
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an ROS1 gene rearrangement as by any nucleic acid-based diagnostic testing method (e.g., next-generation sequencing...
- Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent.
- At least 1 measurable target lesion according to RECIST (v1.1). CNS-only measurable disease as defined by RECIST (v1.1) is allowed.
- Prior cytotoxic chemotherapy for advanced or metastatic disease is allowed. At the time of starting treatment with repotrectinib, at least 14 days or 5 half-lives (whichever is shorter) must have elapsed after...
- Prior immunotherapy (e.g., anti-PD-1, anti-PDL1, anti-TIM3, anti-OX40) is allowed. At the time of starting treatment with repotrectinib, at least 14 days must have elapsed after discontinuation of prior immunotherapy...
- No prior ROS1 TKI is allowed for the TKI naïve cohort.
- Prior ROS1 TKI is allowed for the TKI pretreated cohort (max 30% of patients). At least 7 days or 5 half-lives (whichever is shorter) must have elapsed since completion of treatment with the last ROS1i prior to starting...
- Prior ROS1i allowed include crizotinib, ceritinib, lorlatinib, brigatinib, entrectinib, ensartinib, cabozantinib.
- people with symptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
- Life expectancy ≥3 months
- Subject affiliated to an appropriate social security system
- Adequate hematologic and end-organ function, defined by the following laboratory
- ANC ≥ 1500 /mm3 without granulocyte colony-stimulating factor support
- Lymphocyte count ≥ 500/mm3
- Platelet count ≥ 100,000/mm3 without transfusion
- Hemoglobin ≥ 9.0 g/dL. Patients may be transfused to meet this criterion.
- INR or aPTT ≤ 1.5, upper limit of normal (ULN)
- This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be receiving a stable dose.
- ASAT, ALAT, and alkaline phosphatase ≤ 2.5xULN, with the following exceptions:
- Patients with documented liver metastases: ASAT and/or ALAT ≤ 5xULN
- Patients with documented liver or bone metastases: alkaline phosphatase \< 5xULN
- Serum bilirubin ≤1.25xULN
- Patients with known Gilbert disease who have serum bilirubin level ≤ 3xULN may be enrolled.
- Calculated creatinine clearance (CRCL) ≥ 45 mL/min
- Adequate method of contraception during the treatment period
- For Females: All women of childbearing potential (WOCBP) must agree to avoid pregnancy during the study and must use a highly effective method of contraception during study treatment with repotrectinib and for at least...
- For Males: Male participants with WOCBP partners must use latex condoms during treatment with repotrectinib and for 4 months following the final dose even if the participant has undergone a successful vasectomy or if...
What rules you out
- Malignancies other than NSCLC within 2 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS ≥ 90%) treated with expected curative outcome (such as...
- Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved...
- Active tuberculosis
- Severe infections within 2 weeks prior to inclusion, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to inclusion, unstable arrhythmias...
- Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the course of the study
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or...
- Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures.
- Concurrent participation in any therapeutic clinical trial
- Patient deprived of liberty or placed under the authority of a tutor or a curator
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, Bouches Du Rhône, France
- Marseille, Bouches Du Rhône, France
- Toulon, Var, France
- Angers, France
- Bordeaux, France
- Brest, France
- Caen, France
- Chambéry, France
- Colmar, France
- Créteil, France
- La Roche-sur-Yon, France
- Lille, France
- Limoges, France
- Lyon, France
- Quimper, France
- Rennes, France
- Rouen, France
- Suresnes, France
- Toulouse, France
- Villefranche-sur-Saône, France
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 Aix-en-Provence, Bouches Du Rhône, France; Marseille, Bouches Du Rhône, France; Toulon, Var, France; Angers, France; Bordeaux, France; Brest, France and 14 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.