A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation

Condition(s) studied

Investigational drug(s) / intervention(s)

GFH375: GFH375 administered orally at the protocol-specified dose once daily. Each treatment cycle is 21 days.

Docetaxel: Receive docetaxel via intravenous infusion at 75 mg/m² once every 3 weeks.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Objective Response Rate(ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR) — From the first dose until the date of first documented CR or PR, assessed up to 24 months
  ORR is the proportion of participants whose best response is either complete response (CR) or partial response (PR) per RECIST v1.1 assessed by BICR.
• Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR) — 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.
  PFS is defined as the time from the date of randomization until the date of documented radiographic disease progression per RECIST v1.1, as assessed by BICR or until death due to any cause, whichever comes first.
• Overall Survival (OS) — From the first dose until the date of death from any cause, whichever came first, assessed up to 36~48 months
  OS is defined as the time from the date of randomization until the date of death from any cause.

Trial sites (1)

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