JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation

Summary

This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Eligibility

Inclusion Criteria:

* A signed written informed consent is required before performing any study-related operations
* Age greater than or equal to 18 years old
* Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab
* No history of systemic anticancer therapy to the local advanced/metastatic disease
* Expected survival period greater than or equal to 3 months
* Having at least one target lesion according to RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria:

* Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types
* Carry other driver gene mutations with available target therapy, or carry other KRAS mutations
* Subjects with untreated central nervous system (CNS) metastases were excluded;
* Uncontrolled pleural effusion, pericardial effusion, and ascites
* Subjects with impaired heart function or clinically significant heart disease

Conditions4

Interventions5

Related trials

• A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation. — Allist Pharmaceuticals, Inc.
• A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 — Allist Pharmaceuticals, Inc.
• Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation — Allist Pharmaceuticals, Inc.
• A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies — Shanghai Junshi Bioscience Co., Ltd.
• A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors — CStone Pharmaceuticals
• A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer — HC Biopharma Inc.
• A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC — Sichuan Baili Pharmaceutical Co., Ltd.
• A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer — Peking University Cancer Hospital & Institute

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