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