Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06416410

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Non-squamous Non-small-cell Lung Cancer Metastatic Non-squamous Non Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Province cancer hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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

  1. Objective Response Rate (ORR)

    Time frame: 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

  2. Overall Survival (OS)

    Time frame: From Baseline up to 4 years

    OS is defined as the time from randomization until death due to any cause

  3. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: From Baseline up to 4 years

  4. Number of Participants With Clinically Significant Changes in Vital Signs

    Time frame: From Baseline up to 4 years

  5. Time to Maximum Plasma Concentration (Tmax)

    Time frame: Pre-dose Day 1 up to Day 64

  6. Half life (t1/2)

    Time frame: Pre-dose Day 1 up to Day 64

Other outcomes

  1. Patient Self-Evaluation Results (PRO)

    Time frame: From Baseline up to 4 years

    To be assessed by EORTC OLO-LC13

  2. Patient Self-Evaluation Results (PRO)

    Time frame: From Baseline up to 4 years

    To be assessed by EORTC OLO-C30

  3. Patient Self-Evaluation Results (PRO)

    Time frame: From Baseline up to 4 years

    To be assessed by EuroQoL(EQ)5D

Study contacts

Contact information is provided by the study sponsor or research team.

Shanghai Allist Pharmaceuticals Co., Ltd

CONTACT

[email protected]

021-80423288

Sponsors and collaborators

Lead sponsor

Allist Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 16, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.