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

NSCLC, Stage III Clinical Trial

Official title:

A Phase 2 Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy for Patients With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05386888
• Other study ID #: GFH018X1202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 9, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: Genfleet Therapeutics (Shanghai) Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: January 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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, TGFß 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC, Stage III

Intervention

Drug:
• 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

Radiation:
• Thoracic Radiation Therapy (TRT)
Thoracic Radiation Therapy (TRT)

Drug:
• GFH018
Administered as an IV infusion

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Genfleet Therapeutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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