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

Advanced Non-squamous Non-small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416410
• Other study ID #: JAB-21822-3002
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 17, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: May 2024
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 86-10-56315466
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 392
• Est. completion date: February 28, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Advanced Non-squamous Non-small-cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-squamous Non Small Cell Lung Cancer

Intervention

Drug:
• JAB-21822
JAB-21822 administered orally as a tablet
• Tislelizumab
Tislelizumab administered as an intravenous (IV) infusion
• JAB-3312
JAB-3312 administered orally as a tablet or capsule
• Pemetrexed
Pemetrexed administered as an intravenous (IV) infusion
• Carboplatin
Carboplatin administered as an intravenous (IV) infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Self-Evaluation Results (PRO)	To be assessed by EORTC OLO-LC13	From Baseline up to 4 years
Other	Patient Self-Evaluation Results (PRO)	To be assessed by EORTC OLO-C30	From Baseline up to 4 years
Other	Patient Self-Evaluation Results (PRO)	To be assessed by EuroQoL(EQ)5D	From Baseline up to 4 years
Primary	Outcome Progression-free Survival (PFS)	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).	From Baseline up to 4 years
Secondary	Objective Response Rate (ORR)	Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1	From Baseline up to 4 years
Secondary	Overall Survival (OS)	OS is defined as the time from randomization until death due to any cause	From Baseline up to 4 years
Secondary	Number of Participants With Treatment-Emergent Adverse Events		From Baseline up to 4 years
Secondary	Number of Participants With Clinically Significant Changes in Vital Signs		From Baseline up to 4 years
Secondary	Time to Maximum Plasma Concentration (Tmax)		Pre-dose Day 1 up to Day 64
Secondary	Half life (t1/2)		Pre-dose Day 1 up to Day 64