A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC
NCT ID: NCT05386888
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2022-09-09
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment
GFH018 80mg 7-Day on/ 7-Day off and 4 doses of Toripalimab 240mg Q3W concurrently with standard chemo-radiotherapy, followed by GFH018 80mg 14-Day on/ 14-Day off and Toripalimab 3mg/kg Q2W for up to 48 weeks
GFH018
Administered as oral
Toripalimab
Administered as an IV infusion
Paclitaxel
Administered as an IV infusion
Carboplatin
Administered as an IV infusion
Cisplatin
Administered as an IV infusion
Pemetrexed
Administered as an IV infusion
Thoracic Radiation Therapy (TRT)
Thoracic Radiation Therapy (TRT)
GFH018
Administered as an IV infusion
Interventions
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GFH018
Administered as oral
Toripalimab
Administered as an IV infusion
Paclitaxel
Administered as an IV infusion
Carboplatin
Administered as an IV infusion
Cisplatin
Administered as an IV infusion
Pemetrexed
Administered as an IV infusion
Thoracic Radiation Therapy (TRT)
Thoracic Radiation Therapy (TRT)
GFH018
Administered as an IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Genfleet Therapeutics (Shanghai) Inc.
INDUSTRY
Responsible Party
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Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Other Identifiers
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GFH018X1202
Identifier Type: -
Identifier Source: org_study_id
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