Actively Recruiting
Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC
Led by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Updated on 2026-04-13
30
Participants Needed
20
Research Sites
360 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead Sponsor
G
Groupe Francais De Pneumo-Cancerologie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Repotrectinib is a new-generation TKI designed against ROS1 or NTRK rearranged malignancies (Drilon 2018). Early phase clinical data support activity of repotrectinib in patients with NSCLC harboring such gene rearrangements (TRIDENT-1 study), but there are limited evidence in frail populations, such as poor performance status patients and/or elderly patients, who are classically excluded from clinical trials or underrepresented. The present study aims to assess the activity and tolerability of repotrectinib in frail (PS ≥2) and/or elderly patients with ROS1-rearranged advanced NSCLC.
CONDITIONS
Official Title
Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a performance status of 2 or higher and/or be 70 years or older
- Age 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC with an ROS1 gene rearrangement
- Able and willing to provide informed consent
- At least one measurable target lesion according to RECIST v1.1 (including CNS-only measurable disease)
- Prior cytotoxic chemotherapy allowed with appropriate washout periods and resolved side effects
- Prior immunotherapy allowed with appropriate washout periods and resolved side effects
- No prior ROS1 TKI for TKI-naive cohort; prior ROS1 TKI allowed for pretreated cohort (up to 30% of patients) with appropriate washout and resolved side effects
- Patients with symptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis eligible
- Life expectancy of at least 3 months
- Affiliated with a social security system
- Adequate blood counts and organ function as defined by laboratory values
- Adequate contraception use during treatment period for females and males as specified
You will not qualify if you...
- Other malignancies within 2 years prior to inclusion, except low-risk cancers treated with curative intent
- Active hepatitis B or C infection
- Active tuberculosis
- Severe infections within 2 weeks prior to inclusion
- Significant cardiovascular disease within 3 months prior to inclusion
- Major surgery within 28 days prior to inclusion or planned during study
- Any disease or condition that contraindicates investigational drug use or affects study results
- Conditions interfering with understanding or compliance
- Concurrent participation in another therapeutic clinical trial
- Legal restrictions such as being deprived of liberty or under guardianship
- Investigator assessment of inability or unwillingness to comply with protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
CH Aix-en-Provence
Aix-en-Provence, Bouches Du Rhône, France
Actively Recruiting
2
AP-HM
Marseille, Bouches Du Rhône, France
Actively Recruiting
3
HIA Sainte Anne
Toulon, Var, France
Actively Recruiting
4
CHU Angers
Angers, France
Actively Recruiting
5
CHU Bordeaux
Bordeaux, France
Actively Recruiting
6
CHU Brest
Brest, France
Actively Recruiting
7
Centre François Baclesse
Caen, France
Actively Recruiting
8
CH Chambéry
Chambéry, France
Actively Recruiting
9
Hôpitaux civils de Colmar
Colmar, France
Actively Recruiting
10
CHI Créteil
Créteil, France
Actively Recruiting
11
CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
12
CHRU Lille
Lille, France
Actively Recruiting
13
CHU Limoges
Limoges, France
Actively Recruiting
14
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
15
CH Cornouaille
Quimper, France
Actively Recruiting
16
CHU Rennes
Rennes, France
Actively Recruiting
17
CHU Rouen
Rouen, France
Actively Recruiting
18
Hôpital Foch
Suresnes, France
Actively Recruiting
19
CHU Toulouse
Toulouse, France
Actively Recruiting
20
Hôpitaux Nord-Ouest
Villefranche-sur-Saône, France
Actively Recruiting
Research Team
S
Sophie Lafond
CONTACT
S
Soizic Ferlandin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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