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New cocktail of drugs and radiation takes on tough lung cancer

NCT ID NCT05386888

Disease control Sponsor: Genfleet Therapeutics (Shanghai) Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding two newer drugs—GFH018 and toripalimab—to standard chemoradiotherapy could help people with stage III non-small cell lung cancer that cannot be surgically removed. The study enrolled 65 adults and measured how many patients saw their tumors shrink or disappear. The goal is to find a more effective way to control this advanced cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GFH018 (a targeted drug) and toripalimab (an immunotherapy) combined with chemotherapy (paclitaxel, carboplatin, cisplatin, or pemetrexed) and radiation therapy
What this could lead to
If successful, this combination could offer a new treatment option to shrink or control advanced lung cancer that cannot be removed by surgery.
What could go wrong
This is an early phase 2 trial with only 65 participants, so results may not apply to everyone. Adding multiple drugs and radiation raises the risk of serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

65 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC, stage III

Contacts and locations

Locations

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.