A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC). GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation. Preclinical studies showed GFH375 strongly blocks KRAS-driven signaling and cancer cell growth, and demonstrated anti-tumor activity in NSCLC animal models. Docetaxel is a chemotherapy drug for locally advanced or metastatic NSCLC. This is an open-label, randomized controlled trial. Both participant and study doctor will know which study medication each participant receives. After enrollment, participant will be randomly assigned to either the GFH375 group or docetaxel group by chance. Neither participant nor study doctor can pick your treatment group. You have a two-thirds chance to receive GFH375 and a one-third chance to receive docetaxel. * GFH375 group: Take GFH375 tablets by mouth once daily as scheduled; each treatment cycle lasts 21 days. * Docetaxel group: Receive docetaxel via intravenous infusion at 75 mg/m² once every 3 weeks. Study treatment will continue until cancer gets worse, participant can't tolerate the study treatment, or other conditions make participant unable to keep receiving study treatment. Some participants on docetaxel may be able to switch to GFH375 during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and participant 's wellbeing throughout the study. Participants will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After participant's cancer becomes worse, clinic staff will telephone participant every 3 mouths to check on their cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony zaawansowany rak płuca, który nie może być usunięty chirurgicznie
- •Mutacja KRAS G12D potwierdzona w próbce nowotworu
- •Wcześniej leczony chemioterapią i immunoterapią bez skutku lub ze skutkami ubocznymi
- •Co najmniej jedno widoczne ognisko nowotworu na badaniach obrazowych
- •Spodziewana długość życia co najmniej 12 tygodni
- •Funkcjonowanie wątroby, nerek i serca na poziomie wystarczającym do udziału w badaniu
- •Możliwość regularnego uczestnictwa w wizytach i stosowania się do instrukcji badania
✗ Disqualifies
- •Inne mutacje genetyczne w komórkach nowotworu lub inne mutacje KRAS
- •Inny nowotwór leczony lub postępujący w ostatnich 3 latach
- •Przerzuty do opon mózgowych lub postępujące przerzuty do mózgu
- •Poważne uszkodzenia kości z powodu przerzutów lub ból kości, którego nie da się kontrolować
- •Wcześniejsze leczenie lekami na KRAS G12D lub innymi lekami na KRAS
- •Wcześniejsze leczenie docetaxelem
- •Poważne choroby serca lub udar w ostatnich 6 miesiącach
- •Aktywne ciężkie infekcje bakteryjne, wirusowe lub grzybicze
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Shanghai Lung Cancer Center, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Trial contact
Junnan Dong
Yolanda Zeng
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/11/2026.
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