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New pill takes on tough lung cancer mutation

NCT ID NCT07668752

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 2 times

Summary

This phase 3 trial tests a new daily pill, GFH375, against standard chemotherapy (docetaxel) in 300 people with advanced KRAS G12D lung cancer that has worsened after prior treatments. The drug is designed to block the specific cancer-driving mutation. Participants are randomly assigned to receive either the pill or chemo, and researchers will compare how well each shrinks tumors and delays cancer growth.

What this could mean

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

Active substance
GFH375 (a targeted drug that blocks the KRAS G12D mutation)
What this could lead to
If successful, GFH375 could offer a more effective and less toxic treatment option for people with KRAS G12D lung cancer who have run out of standard options.
What could go wrong
This is an early look at GFH375 in a large trial; it may not prove better than chemo, and side effects are possible. The drug is still experimental.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Apr 2031

An estimate. End dates often move.

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: * 1\. Voluntary participation in the study and signed informed consent form (ICF). * 2\. Age ≥ 18 years at the time of signing the ICF; male or female. * 3\. Histologically or cytologically confirmed locally advanced unresectable or metastatic non small cell lung cancer (NSCLC). * 4\. Participants must provide adequate and qualified tumor tissue slides samples or agree to undergo tumor biopsy to obtain tissue samples for central laboratory confirmation of KRAS G12D mutation. * 5\. Disease progression or intolerance to toxicity after at least one prior line of platinum based chemotherapy and anti PD 1/PD L1 antibody therapy. * 6\. At least one measurable target lesion according to RECIST version 1.1. * 7\. Investigator assessed life expectancy ≥ 12 weeks. * 8\. Adequate organ function. * 9\. Ability to communicate well, comply with scheduled follow up visits, and adhere to protocol requirements. Exclusion Criteria: * 1\. Presence of other driver gene mutations in NSCLC, or concurrent other KRAS or RAS mutations. * 2\. Other malignancy that has progressed or required treatment within 3 years prior to randomization. * 3\. Leptomeningeal metastasis, or symptomatic or progressive central nervous system (CNS) metastasis. * 4\. Existing or potential severe bone injury due to bone metastasis, or uncontrolled pain related to bone metastasis. * 5\. Prior treatment with KRAS G12D targeted therapy or pan RAS/KRAS targeted therapy. * 6\. Prior treatment with docetaxel as part of systemic therapy. * 7\. Radiotherapy within 4 weeks prior to randomization, or other local anti tumor therapy within 4 weeks prior to randomization. * 8\. Other anti tumor therapy within 28 days or 5 half lives prior to randomization, or cell therapy within 3 months prior to randomization. * 9\. Clinically significant severe cardiovascular disease. * 10\. Stroke or other severe cerebrovascular disease within 6 months prior to randomization. * 11\. Major acute or chronic infectious disease. * 12\. Other poorly controlled systemic diseases. * 13\. Severe psychiatric or psychological disorder, or history of drug abuse, or severe alcohol abuse. * 14\. Pregnancy or breastfeeding. * 15\. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Lung Cancer Center, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 201210, China

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