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

Allist Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Non-squamous Non Small Cell Lung Cancer; Advanced Non-squamous Non-small-cell Lung Cancer

Treatments: Drug: JAB-3312; Drug: Tislelizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: JAB-21822

Study type: Interventional

Funder types: Industry

Identifiers

NCT06416410

JAB-21822-3002

Details and patient eligibility

About

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).

Enrollment: 392 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 2 patient groups

JAB-21822+JAB-3312

Experimental group

Description:

JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle

Treatment:

Drug: JAB-21822

Drug: JAB-3312

Tislelizumab combined with Pemetrexed + Carboplatin

Active Comparator group

Description:

Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Drug: Tislelizumab