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

Genfleet Therapeutics (Shanghai) Inc.65 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSCLC, Stage III

Interventions

GFH018DRUG

Administered as oral

ToripalimabDRUG

Administered as an IV infusion

PaclitaxelDRUG

Administered as an IV infusion

Carboplatin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

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