Status:
COMPLETED
A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC
Lead Sponsor:
Genfleet Therapeutics (Shanghai) Inc.
Conditions:
NSCLC, Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II trial assessing the efficacy and safety of GFH018 and Toripalimab in combination with concurrent chemoradiotherapy (cCRT) in patients with unresectable, locally advanced, Stage III ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Newly diagnosed, pathologically (histologically or cytologically) confirmed, locally advanced, unresectable stage III NSCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Measurable disease (according to RECIST v1.1 criteria)
- Life expectancy \> 6 months
Exclusion
- Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements.
- Has received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for Stage III NSCLC
- Prior exposure to immune-mediated therapy, including but not limited to, TGFβ inhibitors, anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies.
- Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
- Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05386888
Start Date
September 9 2022
End Date
December 31 2023
Last Update
October 2 2025
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000