Actively Recruiting
Study on the Mechanism of Acquired Resistance of Entrectinib
Led by Fudan University · Updated on 2025-09-30
38
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to learn about the mechanism of acquired resistance in first line trearment of ROS1-positive NSCLC with entrectinib. The main question it aims to answer is: what is the acquired resistant mechanism of entrectinib as first line treatment setting in patients? Tissue or blood samples of participants who have already taken entrectinib as their regular medical care for NSCLC will send for Next gene sequencing for genomic profiles and bioinformatic analysis.
CONDITIONS
Official Title
Study on the Mechanism of Acquired Resistance of Entrectinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with non-small cell lung cancer (NSCLC) by tissue or cell analysis
- Clinical stage IIIB-IV, unresectable locally advanced, recurrent, or metastatic NSCLC
- ROS1 fusion detected by molecular tests (FISH, RT-PCR, NGS, etc.) in tissue or fluid samples
- At least one measurable tumor lesion per RECIST 1.1 criteria
- No previous systemic anti-cancer treatment for advanced/metastatic disease; prior platinum-based chemo/radiotherapy allowed if progression occurred over 6 months ago
- Patients who progressed or are currently on first-line entrectinib treatment with available tissue or blood samples before and/or after treatment
- Newly diagnosed patients needing first-line entrectinib and agreeing to provide samples before treatment and at progression
- Willing to provide clinical, pathological, imaging data, biological samples, and consent to data use for the study
You will not qualify if you...
- Presence of mixed small cell lung cancer components
- Presence of other druggable targets such as EGFR mutations, ALK fusions, RET fusions, KRAS, BRAF V600E, NTRK fusions, ERBB2 insertions, MET alterations, etc.
- Previous systemic treatment for cancer (chemotherapy, targeted therapy, immunotherapy, anti-angiogenic therapy)
- Other malignancies within past 5 years except low-risk cancers like early-stage prostate or breast cancer
- Contraindications to entrectinib treatment
- Unable to understand or unwilling to sign informed consent, or unable to cooperate with sample collection or follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jialei Wang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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