Status:
UNKNOWN
Glumetinib Combined With Toripalimab in the Treatment of Relapsed or Metastatic Non-small Cell Lung Cancer.
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Relapsed or Metastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, multicenter Phase Ib/II registration clinical study, consisting of two parts: the Phase Ib dose-climbing study and the Phase II efficacy exploration study. Phase Ib : Phase Ib...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subsubjects with histologically or cytologically confirmed NSCLC, clinically diagnosed as locally advanced (stage IIIB or IIIC) and stage IV NSCLC (according to AJCC 8th edition staging), EGFR wild-type, negative for ALK and ROS1 rearrangement, and no Met exon14 skipping mutation; genetic testing is not mandatory for subjects with squamous cell cancer;
- PD - L1 expression of 1% or higher.
- Non-small cell lung cancer patients following failure of or were intolerance to previous standard treatment (chemotherapy and immunotherapy alone or in combination) and received no more than third-line treatment;
- At least 1 measurable tumor lesion according to RECIST1.1 criteria.
- Subjects must provide valid and qualified tissue samples (fresh biopsy or preserved tumor tissue samples are acceptable, but fresh biopsy samples are preferred).
- ECOG score ≤1 point;
- Sufficient function of bone marrow, liver and kidney organs.
- Exclusion criteria:
- Pathological diagnosis confirmed the presence of small cell lung cancer;
- The patient was currently participating in and receiving other studies or had previously received another c-Met inhibitor;
- There are mutations/rearrangements of EGFR, ALK, ROS1, Met14 exon skipping;
Exclusion
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 26 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04797702
Start Date
April 15 2021
End Date
February 26 2024
Last Update
March 15 2021
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510180