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Completed

NCT Number: NCT05386888

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

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).

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Key information

Conditions

NSCLC, Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFH018

Drug

Administered as oral

Toripalimab

Drug

Administered as an IV infusion

paclitaxel

Drug

Administered as an IV infusion

carboplatin

Drug

Administered as an IV infusion

Cisplatin

Drug

Administered as an IV infusion

Pemetrexed

Drug

Administered as an IV infusion

Thoracic Radiation Therapy (TRT)

Radiation

Thoracic Radiation Therapy (TRT)

Primary outcomes

  1. Objective Response Rate (ORR)

    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

    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.

Sponsors and collaborators

Lead sponsor

Genfleet Therapeutics (Shanghai) Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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