Clinical trial · Interventional
A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sosimerasib in combination with IN10018 | Drug | — | UNRESOLVED |
| Tislelizumab + Carboplatin + Pemetrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Arm
- description
- Sosimerasib in combination with IN10018
- interventionNames
- Drug: Sosimerasib in combination with IN10018
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- anti-PD-1 monoclonal antibody in combination with chemotherapy
- interventionNames
- Drug: Tislelizumab + Carboplatin + Pemetrexed
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 30 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease. 2. Has KRAS G12C mutation confirmed by central laboratory. 3. Measurable disease according to RECIST 1.1. 4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1. 5. Adequate organ function. 6. Life expectancy ≥3 months in the opinion of the Investigator 7. Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment Exclusion Criteria: 1. Has another known driver mutation with approved first-line targeted therapy. 2. Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled. 3. Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors. 4. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies. 5. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption. 6. Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease. 7. Any condition that, in the opinion of the Investigator, would interfere with participation or study results
References
Publications (0)
Data not yet available