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

Study arms

• Experimental
  JAB-21822+JAB-3312

  JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle

  Drug: JAB-21822 · Drug: JAB-3312

• Active comparator
  Tislelizumab combined with Pemetrexed + Carboplatin

  Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle

  Drug: Tislelizumab · Drug: Pemetrexed · Drug: Carboplatin

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

Primary outcomes

1. 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).

   Time frame: From Baseline up to 4 years

Secondary outcomes

1. 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

   Time frame: From Baseline up to 4 years

2. Overall Survival (OS)

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

   Time frame: From Baseline up to 4 years

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)

   To be assessed by EORTC OLO-LC13

   Time frame: From Baseline up to 4 years

2. Patient Self-Evaluation Results (PRO)

   To be assessed by EORTC OLO-C30

   Time frame: From Baseline up to 4 years

3. Patient Self-Evaluation Results (PRO)

   To be assessed by EuroQoL(EQ)5D

   Time frame: From Baseline up to 4 years