--- title: 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 nct_id: NCT06416410 overall_status: RECRUITING phase: PHASE3 sponsor: Allist Pharmaceuticals, Inc. study_type: INTERVENTIONAL primary_condition: Advanced Non-squamous Non-small-cell Lung Cancer countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06416410.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06416410" ct_last_update_post_date: 2025-04-04 last_seen_at: "2026-05-12T06:54:18.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **Official Title:** An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation **NCT ID:** [NCT06416410](https://clinicaltrials.gov/study/NCT06416410) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 392 - **Lead Sponsor:** Allist Pharmaceuticals, Inc. - **Conditions:** Advanced Non-squamous Non-small-cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer - **Start Date:** 2024-08-07 - **Completion Date:** 2027-02-28 - **CT.gov Last Update:** 2025-04-04 ## Brief 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **JAB-21822+JAB-3312** (EXPERIMENTAL) — JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle - **Tislelizumab combined with Pemetrexed + Carboplatin** (ACTIVE_COMPARATOR) — Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle ## Interventions - **JAB-21822** (DRUG) — JAB-21822 administered orally as a tablet - **Tislelizumab** (DRUG) — Tislelizumab administered as an intravenous (IV) infusion - **JAB-3312** (DRUG) — JAB-3312 administered orally as a tablet or capsule - **Pemetrexed** (DRUG) — Pemetrexed administered as an intravenous (IV) infusion - **Carboplatin** (DRUG) — Carboplatin administered as an intravenous (IV) infusion ## Primary Outcomes - **Outcome Progression-free Survival (PFS)** _(time frame: From Baseline up to 4 years)_ — PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC). ## Secondary Outcomes - **Objective Response Rate (ORR)** _(time frame: From Baseline up to 4 years)_ - **Overall Survival (OS)** _(time frame: From Baseline up to 4 years)_ - **Number of Participants With Treatment-Emergent Adverse Events** _(time frame: From Baseline up to 4 years)_ - **Number of Participants With Clinically Significant Changes in Vital Signs** _(time frame: From Baseline up to 4 years)_ - **Time to Maximum Plasma Concentration (Tmax)** _(time frame: Pre-dose Day 1 up to Day 64)_ - **Half life (t1/2)** _(time frame: Pre-dose Day 1 up to Day 64)_ ## Locations (37) - Anhui Province cancer hospital, Hefei, Anhui, China — _NOT_YET_RECRUITING_ - Pecking Union Medical College Hospital, Beijing, Beijing Municipality, China — _NOT_YET_RECRUITING_ - Cancer Hospital Chinese Academy Of Medical Sciences, Beijing, Beijing Municipality, China — _RECRUITING_ - Beijing Tiantan Hospital, Captal Medical University, Beijing, Beijing Municipality, China — _NOT_YET_RECRUITING_ - Beijing Cancer Hospital, Beijing, Beijing Municipality, China — _RECRUITING_ - Peking University Third Hospital, Beijing, Beijing Municipality, China — _RECRUITING_ - Beijing Chest Hospital ,Capital Medical University, Beijing, Beijing Municipality, China — _RECRUITING_ - Fujian cancer Hospital, Fuzhou, Fujian, China — _NOT_YET_RECRUITING_ - The first Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China — _NOT_YET_RECRUITING_ - Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center, Shenzhen, Guangdong, China — _NOT_YET_RECRUITING_ - Guangxi Medical University Cancer hospital & Guangxi Cancer Institute, Nanning, Guangxi, China — _NOT_YET_RECRUITING_ - Cangzhou hospital of integrated TCM-WM Hebei, Cangzhou, Hebei, China — _RECRUITING_ - Harbin Medical University Cancer Hospital-Mammary gland of internal, Haerbin, Heilongjiang, China — _NOT_YET_RECRUITING_ - Henan Cancer Hospital, Zhengzhou, Henan, China — _NOT_YET_RECRUITING_ - The First Affiliated Hosipital Of Zhengzhou University, Zhengzhou, Henan, China — _NOT_YET_RECRUITING_ - Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China — _NOT_YET_RECRUITING_ - Tongji Hospital Tongji Medical College of Hust, Wuhan, Hubei, China — _NOT_YET_RECRUITING_ - Hubei cancer hospital, Wuhan, Hubei, China — _NOT_YET_RECRUITING_ - Hunan Cancer Hospital, Changsha, Hunan, China — _NOT_YET_RECRUITING_ - Jiangsu province hospital, Nanjing, Jiangsu, China — _NOT_YET_RECRUITING_ - Wuxi People's Hospital, Wuxi, Jiangsu, China — _NOT_YET_RECRUITING_ - Jilin cancer hospital, Jilin, Jilin, China — _NOT_YET_RECRUITING_ - The First Hospital Of China Medical University, Shenyang, Liaoning, China — _NOT_YET_RECRUITING_ - Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China — _NOT_YET_RECRUITING_ - Shandong Cancer Hospital, Jinan, Shandong, China — _RECRUITING_ - LinYi Cancer Hospital, Linyi, Shandong, China — _NOT_YET_RECRUITING_ - The affiliated hospital of Qingdao university, Qingdao, Shandong, China — _NOT_YET_RECRUITING_ - Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China — _NOT_YET_RECRUITING_ - Shanghai Pulmonary Hospital, Shanghai, Shanghai Municipality, China — _NOT_YET_RECRUITING_ - Shanxi province cancer hospital, Taiyuan, Shanxi, China — _NOT_YET_RECRUITING_ - The First Affiliated Hospital of Xi'An Jiaotong University, Xi’an, Shanxi, China — _NOT_YET_RECRUITING_ - Sichuan province cancer hospital, Chengdu, Sichuan, China — _NOT_YET_RECRUITING_ - West China Hospital Sichuan University, Chengdu, Sichuan, China — _NOT_YET_RECRUITING_ - Tianjin Medical University Cancer Institute Hospital, Tianjin, Tianjin Municipality, China — _NOT_YET_RECRUITING_ - The First affiliated hospital Zhejiang university school of medicine, Hangzhou, Zhejiang, China — _NOT_YET_RECRUITING_ - The Second Affiliated Hospital Zhejiang School of Medicine, Hangzhou, Zhejiang, China — _NOT_YET_RECRUITING_ - Taizhou Hospital Zhejiang Province, Taizhou, Zhejiang, China — _NOT_YET_RECRUITING_ ## Recent Field Changes (last 30 days) - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.peking university third hospital|beijing|beijing municipality|china` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.anhui province cancer hospital|hefei|anhui|china` — added _(2026-05-12)_ - `locations.pecking union medical college hospital|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.cancer hospital chinese academy of medical sciences|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing tiantan hospital, captal medical university|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing cancer hospital|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing chest hospital ,capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.fujian cancer hospital|fuzhou|fujian|china` — added _(2026-05-12)_ - `locations.the first affiliated hospital, sun yat-sen university|guangzhou|guangdong|china` — added _(2026-05-12)_ - `locations.cancer hospital chinese academy of medical sciences shenzhen center|shenzhen|guangdong|china` — added _(2026-05-12)_ - `locations.guangxi medical university cancer hospital & guangxi cancer institute|nanning|guangxi|china` — added _(2026-05-12)_ - `locations.cangzhou hospital of integrated tcm-wm hebei|cangzhou|hebei|china` — added _(2026-05-12)_ - `locations.harbin medical university cancer hospital-mammary gland of internal|haerbin|heilongjiang|china` — added _(2026-05-12)_ - `locations.henan cancer hospital|zhengzhou|henan|china` — added _(2026-05-12)_ - `locations.the first affiliated hosipital of zhengzhou university|zhengzhou|henan|china` — added _(2026-05-12)_ - `locations.union hospital tongji medical college huazhong university of science and technology|wuhan|hubei|china` — added _(2026-05-12)_ - `locations.tongji hospital tongji medical college of hust|wuhan|hubei|china` — added _(2026-05-12)_ - `locations.hubei cancer hospital|wuhan|hubei|china` — added _(2026-05-12)_ - `locations.hunan cancer hospital|changsha|hunan|china` — added _(2026-05-12)_ - `locations.jiangsu province hospital|nanjing|jiangsu|china` — added _(2026-05-12)_ - `locations.wuxi people's hospital|wuxi|jiangsu|china` — added _(2026-05-12)_ - `locations.jilin cancer hospital|jilin|jilin|china` — added _(2026-05-12)_ - `locations.the first hospital of china medical university|shenyang|liaoning|china` — added _(2026-05-12)_ - `locations.liaoning cancer hospital & institute|shenyang|liaoning|china` — added _(2026-05-12)_ - `locations.shandong cancer hospital|jinan|shandong|china` — added _(2026-05-12)_ - `locations.linyi cancer hospital|linyi|shandong|china` — added _(2026-05-12)_ - `locations.the affiliated hospital of qingdao university|qingdao|shandong|china` — added _(2026-05-12)_ - `locations.fudan university shanghai cancer center|shanghai|shanghai municipality|china` — added _(2026-05-12)_ - `locations.shanghai pulmonary hospital|shanghai|shanghai municipality|china` — added _(2026-05-12)_ - `locations.shanxi province cancer hospital|taiyuan|shanxi|china` — added _(2026-05-12)_ - `locations.the first affiliated hospital of xi'an jiaotong university|xi’an|shanxi|china` — added _(2026-05-12)_ - `locations.sichuan province cancer hospital|chengdu|sichuan|china` — added _(2026-05-12)_ - `locations.west china hospital sichuan university|chengdu|sichuan|china` — added _(2026-05-12)_ - `locations.tianjin medical university cancer institute hospital|tianjin|tianjin municipality|china` — added _(2026-05-12)_ - `locations.the first affiliated hospital zhejiang university school of medicine|hangzhou|zhejiang|china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06416410.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06416410* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*