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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

NCT06416410

RecruitingPhase 3

Sponsor: Allist Pharmaceuticals, Inc.

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

Interventions: JAB-21822, Tislelizumab, JAB-3312, Pemetrexed, Carboplatin

Countries: China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (37)

Hefei, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Nanning, Guangxi, China
Cangzhou, Hebei, China
Haerbin, Heilongjiang, China
Zhengzhou, Henan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Wuxi, Jiangsu, China
Jilin City, Jilin, China
Shenyang, Liaoning, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Linyi, Shandong, China
Qingdao, Shandong, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Taiyuan, Shanxi, China
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