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

Recruiting Phase 3 Interventional Study
Non-Small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
InxMed (Shanghai) Co., Ltd. · Industry
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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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 la…
Contacts

Shu Fang Project Manager, bachelor

86-15933968623

shu.fang@inxmed.com

CONTACT

Jack Zhang Clinical Trial Manager, bachelor

jack.zhang@inxmed.com

CONTACT