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).
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
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)
Parallel
IN10018 in combination with D-1553
DrugIN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle
anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed
DrugTislelizumab 200mg Q3W IV + Carboplatin AUC 5 mg/mL/min or Cisplatin 75mg/m² Q3W IV+ Pemetrexed 500mg/m² Q3W IV
Progression-Free Survival (PFS)
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).
Objective Response Rate (ORR)
Defined as complete response (PR) + partial response (PR) assessed per RECIST v1.1 by BICR
Overall Survival (OS)
Defined as time from randomization to death by any cause
Disease Control Rate (DCR)
Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by BICR
Duration of Response (DoR)
Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first. assessed per RECIST v1.1 by BICR
PK: Cmax of IN10018 and D-1553
Maximum concentration (Cmax)
PK: Cmin of IN10018 and D-1553
Minimum concentration (Cmin)
PK: AUC of IN10018 and D-1553
Area under the concentration-time curve (AUC)
Patient-reported outcome (PRO) questionnaire
Reports of health status directly from patients
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