NSCLC, Stage IIIPhase 2NCT05386888

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

A Phase 2 study testing GFH018, Toripalimab and Paclitaxel in people with NSCLC, Stage III, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC, Stage III
What is being tested?: GFH018, Toripalimab and Paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteChina
Study dates: 9 Sep 2022to 31 Dec 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

China1 site

West China Hospital, Sichuan University
Chengdu, Sichuan, 610000

Other trials in China

About this study

Official 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)

Conditions: NSCLC, Stage III
Being tested: GFH018, Toripalimab, Paclitaxel, Carboplatin, Cisplatin
Keywords: Locally Advanced, Unresectable NSCLC, TGF-βRI, PD-1
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GFH018Drug
Administered as oral
ToripalimabDrug
Administered as an IV infusion
PaclitaxelDrug
Administered as an IV infusion
CarboplatinDrug
Administered as an IV infusion
CisplatinDrug
Administered as an IV infusion
PemetrexedDrug
Administered as an IV infusion
Thoracic Radiation Therapy (TRT)Radiation
Thoracic Radiation Therapy (TRT)
GFH018Drug
Administered as an IV infusion

Study groups in NCT05386888
Study group	Role	What they receive
treatment	Experimental	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 Receives: Drug: GFH018; Drug: Toripalimab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Radiation: Thoracic Radiation Therapy (TRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 202231 Dec 2023

First posted23 May 2022
Study start9 Sep 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLC, Stage IIIStudies of the same condition, open and under way.
More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Primary Purpose: ORR
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05386888
Sponsor's protocol ID: GFH018X1202
Status last verified: Sep 2025
First submitted: 12 May 2022
Last updated: 2 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT05386888
Acronym / sponsor ID: GFH018X1202
Conditions: NSCLC, Stage III
Keywords: Locally Advanced, Unresectable NSCLC, TGF-βRI, PD-1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
Study start: 9 Sep 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 23 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Primary Purpose: ORR

Arm	Type	Receives
treatment	Experimental	Drug: GFH018, Drug: Toripalimab, Drug: Paclitaxel, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Radiation: Thoracic Radiation Therapy (TRT)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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GFH018Administered as oral	Drug	treatment
ToripalimabAdministered as an IV infusion	Drug	treatment
PaclitaxelAdministered as an IV infusion	Drug	treatment
CarboplatinAdministered as an IV infusion	Drug	treatment
CisplatinAdministered as an IV infusion	Drug	treatment
PemetrexedAdministered as an IV infusion	Drug	treatment
Thoracic Radiation Therapy (TRT)Thoracic Radiation Therapy (TRT)	Radiation	treatment
GFH018Administered as an IV infusion	Drug	treatment

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GFH018, Toripalimab and Paclitaxel in people with NSCLC, Stage III, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.