A Phase 2 interventional study of ArmA:GFH375 and Arm B:GFH375 in NSCLC (Advanced Non-small Cell Lung Cancer), sponsored by Genfleet Therapeutics (Shanghai) Inc.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China — 763 open to participants now, 986 under way, 203 of them phase 3. Carcinoma, Non-Small-Cell Lung · China.
Among the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, this one is the 831st largest by planned enrollment of the 1,592 interventional ones that give a count, is one of 189 that started in 2026, is one of 650 in phase 2, reaches primary completion later than 535 of the 985 other live ones, and was the 1,757th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →763 of the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China are open now. Recruiting first, the newest first:
Jiangsu Hansoh Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Sichuan Baili Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Ruijin Hospital · Sites in China
Ages 18+
Daiichi Sankyo · Sites in China, United States, Argentina and 10 more countries
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,878 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 360 · Phase 2 847 · Phase 3 404 · Phase 4 40
First in 1996; this study’s year is marked. 189 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 100 across the 1,592 interventional studies, 200 across the 286 observational. Of the 453 that completed or were terminated, 130 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
803 of 1,878 have an industry lead sponsor. The 10 most frequent:
Genfleet Therapeutics (Shanghai) Inc. is the lead sponsor of 18 studies on the registry; 14 are open to participants now.
Genfleet Therapeutics (Shanghai) Inc. has 5 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
225 of the studies in Carcinoma, Non-Small-Cell Lung with a site in China that are under way reach primary completion within a year, 33 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06448312Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT06704620Phase 3Tianjin Medical University Cancer Institute and HospitalStudy of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT05429463Phase 3Second Affiliated Hospital, Zhejiang University, School of MedicineNeoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ） | 2026-11-30 |
| NCT06711900Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer | 2026-12 |
| NCT06382129Phase 3Sichuan Baili Pharmaceutical Co., Ltd.A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02) | 2026-12 |
Add all 225 to your calendar (.ics) → With an account.
Among the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
9. of at least 3 months as assessed by the investigator. 10.Adequate organ function.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm A :will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Drug: ArmA:GFH375
Arm B will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Drug: Arm B:GFH375
Arm C will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Drug: Arm C:GFH375
GFH375 once daily (QD) 28 days as a cycle.
Also known as: GFH375
GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
Also known as: Cetuximab
GFH375 once daily (QD) .Pemetrexed disodium will be administered via intravenous infusion at a dose of 500 mg/m² every 3 weeks.
Also known as: Pemetrexed disodium
the efficacy of GFH375 as monotherapy and in combination therapy
Objective response rate (ORR) assessed by RECIST 1.1 according to researchers
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Apr 2027, 11 months later.
Of 317 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's planned 11 months is below that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: KRAS G12D Inhibitor VS-7375
Carcinoma, Non-Small-Cell Lung →
Genfleet Therapeutics (Shanghai) Inc. →