A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC

NCT05386888 | Completed Phase 2

• 1 other identifier: GFH018X1202
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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 non-small cell lung cancer (NSCLC).

Conditions

NSCLC, Stage III

Keywords

Locally Advanced; Unresectable NSCLC; TGF-βRI; PD-1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate (ORR) is defined as the percentage of patients with objective response (OR). OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response (Complete Response (disappearance of all target and non-target lesions; no new lesions) or Partial Response (≥decrease in the sum of the largest diameters of target lesions; no new lesions)) across all assessment points from enrollment to termination of trial treatment. Radiological tumour assessment was performed using CT scans.

  From the date of enrolment of the first patient up to 28 months , which is also16 months after the enrolment of the last patient

Study Arms (1)

treatment

EXPERIMENTAL

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

Drug: GFH018; Drug: Toripalimab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Radiation: Thoracic Radiation Therapy (TRT)

Interventions

GFH018 DRUG

Administered as oral

treatment

Toripalimab DRUG

Administered as an IV infusion

treatment

Paclitaxel DRUG

Administered as an IV infusion

treatment

Carboplatin DRUG

Administered as an IV infusion

treatment

Cisplatin DRUG

Administered as an IV infusion

treatment

Pemetrexed DRUG

Administered as an IV infusion

treatment

Thoracic Radiation Therapy (TRT) RADIATION

Thoracic Radiation Therapy (TRT)

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genfleet Therapeutics (Shanghai) Inc.: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab; Paclitaxel; Carboplatin; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Primary Purpose: ORR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 23, 2022
• Study Start: September 9, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)