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Recruiting 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

Phase III Interventional Advanced Non-squamous Non-small-cell Lung Cancer Metastatic Non-squamous Non Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JAB-21822, Tislelizumab, JAB-3312, Pemetrexed.
Who it may be relevant to
Registry conditions: Advanced Non-squamous Non-small-cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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

Primary outcome measures

  • Outcome Progression-free Survival (PFS) [Time frame: From Baseline up to 4 years]
Secondary outcome measures (6)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 37 centers
  • Anhui Province cancer hospital — Hefei
  • Pecking Union Medical College Hospital — Beijing
  • Cancer Hospital Chinese Academy Of Medical Sciences — Beijing
  • Beijing Tiantan Hospital, Captal Medical University — Beijing
  • Beijing Cancer Hospital — Beijing
  • Peking University Third Hospital — Beijing
  • Beijing Chest Hospital ,Capital Medical University — Beijing
  • Fujian cancer Hospital — Fuzhou
  • … and 29 more centers

Identifiers

NCT: NCT06416410 · JAB-21822-3002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗