New pill takes on tough lung cancer mutation
NCT ID NCT07668752
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Apr 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shanghai Lung Cancer Center, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 201210, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a targeted pill after surgery keep early lung cancer from returning?
- Can a new immune drug outsmart Hard-to-Treat tumors?
- Can a pill plus immunotherapy and targeted radiation shrink lung tumors before surgery?
- Can a targeted drug combo boost chemoradiation in EGFR-Positive lung cancer?