Advanced Non-squamous Non-small-cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer
Conditions
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).
Interventions
DRUGJAB-21822
JAB-21822 administered orally as a tablet
DRUGTislelizumab
Tislelizumab administered as an intravenous (IV) infusion
DRUGJAB-3312
JAB-3312 administered orally as a tablet or capsule
DRUGPemetrexed
Pemetrexed administered as an intravenous (IV) infusion
DRUGCarboplatin
Carboplatin administered as an intravenous (IV) infusion
Sponsors
Allist Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome Progression-free Survival (PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From Baseline up to 4 years | Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1 |
| Overall Survival (OS) | From Baseline up to 4 years | OS is defined as the time from randomization until death due to any cause |
| Number of Participants With Treatment-Emergent Adverse Events | From Baseline up to 4 years | — |
| Number of Participants With Clinically Significant Changes in Vital Signs | From Baseline up to 4 years | — |
| Time to Maximum Plasma Concentration (Tmax) | Pre-dose Day 1 up to Day 64 | — |
| Half life (t1/2) | Pre-dose Day 1 up to Day 64 | — |
Countries
China
Contacts
CONTACTShanghai Allist Pharmaceuticals Co., Ltd
PRINCIPAL_INVESTIGATORWang Jie M.D.
Cancer Institute and Hospital
Outcome results
None listed