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

GenFleet Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: NSCLC, Stage III

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05386888

GFH018X1202

Details and patient eligibility

About

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).

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

treatment

Experimental group

Description:

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

Treatment:

Drug: GFH018

Radiation: Thoracic Radiation Therapy (TRT)

Drug: Toripalimab

Drug: Paclitaxel

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Drug: GFH018