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

• Status: Not yet recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II trial assessing the efficacy and safety of GFH018 in combination with Toripalimab given concurrently with platinum-based chemoradiotherapy (CRT) in patients with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genfleet Therapeutics (Shanghai) Inc.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Histologically or cytologically confirmed non small cell lung carcinoma 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:

• Patient with mixed small-cell and non-small-cell histologic features Patient with pleural or pericardial effusions proven to be malignant Prior or current cancer treatment, including but not limited to, chemotherapy, radiotherapy or molecular targeted therapy for 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.