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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2NCT07554859

GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer

A Phase 2 study testing ArmA:GFH375, Arm B:GFH375 and Arm C:GFH375 in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Genfleet Therapeutics (Shanghai) Inc. at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ArmA:GFH375, Arm B:GFH375 and Arm C:GFH375
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesChina
Study dates
20 May 2026to 30 Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily agree to participate in this study and sign the written informed consent form.
  • Male or female, aged 18 to 75 years at the time of signing the informed consent form.
  • Pathologically (histologically or cytologically) confirmed advanced (Stage IV) or locally advanced non-squamous non-small cell lung cancer that is not amenable to radical surgery or radiotherapy.
  • Have a written report confirming KRAS G12D mutation positive.
  • Able to provide an archival tumor tissue sample [formalin-fixed, paraffin-embedded (FFPE) block or unstained FFPE tumor sections] or to undergo a tumor biopsy prior to treatment.
  • No prior systemic anti-tumor therapy for advanced disease; or not eligible for standard of care therapy; or in the investigator's judgment, may benefit more from GFH375 monotherapy or combination therapy than from available standard therapy.
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  • Have at least one measurable lesion outside the central nervous system (CNS) per RECIST v1.1. Lesions that have received prior local radiotherapy can be considered measurable only if they have demonstrated clear progression after radiotherapy; otherwise, they are not considered measurable.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
  • 9.Life expectancy of at least 3 months as assessed by the investigator. 10.Adequate organ function.

Who cannot join

  • Has had another invasive malignancy that progressed or required treatment within 3 years prior to randomization, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, squamous cell carcinoma in situ, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.
  • Pathologically (histologically or cytologically) confirmed squamous cell lung cancer, adenosquamous carcinoma, neuroendocrine carcinoma (including small cell lung cancer and large cell neuroendocrine carcinoma), or mixed small cell lung cancer.
  • Known to harbor other targetable driver gene alterations.
  • Has active or symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression.
  • Has clinically significant severe cardiovascular disease.
  • Has had a stroke or other serious cerebrovascular event within 6 months prior to randomization.
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  • Has a history of deep vein thrombosis or other severe thromboembolism within 3 months prior to randomization.
  • Has pleural effusion, ascites, or pericardial effusion requiring frequent drainage (≥2 times per month) or associated with moderate to severe symptoms.
  • Has clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.
  • At high risk of gastrointestinal bleeding or perforation.
  • Has pyloric obstruction, persistent or recurrent vomiting (≥3 episodes within 24 hours); is unable or unwilling to swallow tablets; or has other impaired gastrointestinal function or gastrointestinal disease that may significantly affect the absorption of GFH375.
  • History of chronic diarrhea.
  • Has a major acute or chronic infectious disease.
  • Has other uncontrolled systemic medical conditions.
  • Planned major surgery as determined by the investigator.
  • History of organ transplantation or preparing to undergo organ transplantation (except corneal transplantation).
  • Known allergy to the investigational drug or its components.
  • Received or planned to receive a live attenuated vaccine within 28 days prior to randomization or during the administration of the investigational drug.
  • Having severe mental or psychological disorders, a history of substance abuse, or a history of severe alcoholism.
  • Pregnant or breastfeeding women.
  • Other conditions deemed by the investigator to be inappropriate for participation in the study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yolanda Zeng contact

+8618073129952

yaozeng@genfleet.com

Dandan Li contact

+8615357948985

ddli@genfleet.com

China2 sites

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Chongrui Xu

Other trials in China

About this study

Official title: A Multicenter, Open-label, Randomized Clinical Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of GFH375 Monotherapy and Combination Therapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer Harboring KRAS G12D Mutation.

This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed (Cohort 3).Every cohort will recruit 30 participants.

Read the detailed description

This study is a multicenter, open-label, randomized clinical trial designed to evaluate the efficacy and safety of three treatment regimens in patients with previously untreated advanced NSCLC harboring KRAS G12D mutations: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed (Cohort 3).

The study population consists of participants with advanced, previously untreated NSCLC carrying KRAS G12D mutations. Participants must not have received any prior systemic anti-tumor therapy. After enrollment, participants will be randomized to one of the following cohorts:

Cohort 1: GFH375 monotherapy (600 mg, QD, oral), approximately 30 participants. Cohort 2: GFH375 (600 mg, QD, oral) combined with cetuximab (500 mg/m², Q2W, intravenous), approximately 30 participants.

Cohort 3: GFH375 (600 mg, QD, oral) combined with pemetrexed (500 mg/m², Q3W, intravenous), approximately 30 participants.

A total of approximately 90 participants will be enrolled in this study, and each participant will be randomized to only one cohort.

Being tested
ArmA:GFH375, Arm B:GFH375, Arm C:GFH375
Keywords
KRAS G12D Mutations
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.

  • ArmA:GFH375Drug

    Also called GFH375

    GFH375 once daily (QD) 28 days as a cycle.

  • Arm B:GFH375Drug

    Also called Cetuximab

    GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.

  • Arm C:GFH375Drug

    Also called Pemetrexed disodium

    GFH375 once daily (QD) .Pemetrexed disodium will be administered via intravenous infusion at a dose of 500 mg/m² every 3 weeks.

Study groups in NCT07554859
Study groupRoleWhat they receive
Arm A:GFH375ExperimentalArm A :will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Receives: Drug: ArmA:GFH375
Arm B:GFH375 in combination with CetuximabExperimentalArm B will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Receives: Drug: Arm B:GFH375
Arm C:GFH375 in combination with PemetrexedExperimentalArm C will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Receives: Drug: Arm C:GFH375

What is being measured

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

  1. the efficacy of GFH375 as monotherapy and in combination therapy

    Objective response rate (ORR) assessed by RECIST 1.1 according to researchers

    Measured: From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Timeline

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

  1. First posted28 Apr 2026
  2. Study start20 May 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07554859
Sponsor's protocol ID
GFH375X1302
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ArmA:GFH375, Arm B:GFH375 and Arm C:GFH375 in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Genfleet Therapeutics (Shanghai) Inc. at 2 sites 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 9 inclusion and 21 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yolanda Zeng (+8618073129952, yaozeng@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the efficacy of GFH375 as monotherapy and in combination therapy (time frame: From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 NCT07554859.

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 28 Apr 2026.

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