A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInxMed (Shanghai) Co., Ltd.

About this trial

This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).

Eligibility criteria

Qualifiers

Able and willing to provide informed consent and comply with study requirements

Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC

Aged 18-80 years at the time of consent

Has KRAS G12C mutation confirmed by central laboratory

Disqualifiers

Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)

Has active or untreated CNS metastases or carcinomatous meningitis

Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors

Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)

Trial design

Treatments tested in this trial

  • IN10018 in combination with D-1553
  • anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators