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NCT05386888CompletedPhase 2

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

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)

Source: ClinicalTrials.gov · Last updated 2 Oct 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
65 (actual)
First submitted
12 May 2022
Start date
9 Sept 2022
Primary completion date
31 Dec 2023
Lead sponsor
Genfleet Therapeutics (Shanghai) Inc.
Diseases
Lung cancer
NCT number
NCT05386888

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 65
  • From 9 Sept 2022 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements.
  • Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.