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Combining JAB-21822 and JAB-3312 for advanced lung cancer with KRAS mutation

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

Phase 3 Interventional Allist Pharmaceuticals, Inc. · NCT06416410

This study is testing if a new combination of JAB-21822 and JAB-3312 can help people with advanced lung cancer that has a specific KRAS mutation do better than the usual treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment392 (estimated)
Ages18 Years and up
SexAll
SponsorAllist Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionstislelizumab
Locations37 sites (Hefei, Anhui and 36 other locations)
Trial IDNCT06416410 on ClinicalTrials.gov

What this trial studies

This Phase 3 study evaluates the effectiveness of a combination of JAB-21822 and JAB-3312 compared to standard treatment with tislelizumab, pemetrexed, and carboplatin for patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS p.G12C mutation. The trial aims to determine if this new combination can provide better outcomes than the current standard of care. Participants will be monitored for their response to treatment and any side effects experienced during the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed KRAS p.G12C mutated advanced or metastatic non-squamous NSCLC who have not received prior systemic therapy.

Not a fit: Patients with other driver gene mutations that have available targeted therapies or those with untreated central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with advanced lung cancer and KRAS mutations.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, but this specific combination approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Hefei, Anhui and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Non-squamous Non-small-cell Lung CancerMetastatic Non-squamous Non Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.