Clinical trial · Interventional
A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
NCT07174908CI-TRIAL-00104478recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed | Drug | — | UNRESOLVED |
| IN10018 in combination with D-1553 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IN10018 plus D-1553
- description
- Subjects receive IN10018 100mg orally once daily (QD) and D-1553 600mg orally twice daily (BID) on Days 1-21 of each 21-day cycle, until disease progression or unacceptable toxicity.
- interventionNames
- Drug: IN10018 in combination with D-1553
- type
- ACTIVE_COMPARATOR
- label
- Tislelizumab plus Platinum and Pemetrexed
- description
- Subjects receive Tislelizumab 200mg intravenously (IV) once every 3 weeks (Q3W) until disease progression, plus Carboplatin (AUC = 5 mg/mL/min, Q3W, IV) or Cisplatin (75 mg/m², Q3W, IV) for up to 4 cycles, in combination with Pemetrexed (500 mg/m², Q3W, IV) until disease progression.
- interventionNames
- Drug: anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Able and willing to provide informed consent and comply with study requirements * Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC * Aged 18-80 years at the time of consent * Has KRAS G12C mutation confirmed by central laboratory * Has not received prior systemic therapy for advanced or metastatic NSCLC * Has at least one measurable lesion per RECIST v1.1 * ECOG performance status of 0-1 * Has adequate organ function * Life expectancy ≥3 months in the opinion of the Investigator * Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment Exclusion Criteria: * Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine) * Has active or untreated CNS metastases or carcinomatous meningitis * Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors * Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1) * Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy * Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ) * Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable) * Has known active hepatitis B, hepatitis C, or HIV infection * Has received a live vaccine within 30 days before first dose of study drug * Pregnant or breastfeeding women * Has psychiatric or substance abuse disorders that would interfere with study compliance * Is participating in another interventional clinical study * Any condition that, in the opinion of the Investigator, would interfere with participation or study results
References
Publications (1)
- DERIVEDSong Z, Li X, Lin R, Shi H, Yuan Y, Liu Y, Luo Y, Lv T, Zhang Y, Zhu L, Zhu Y, Zhang L, Wang Z. Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. Lancet Respir Med. 2026 Jul 7:S2213-2600(26)00142-6. doi: 10.1016/S2213-2600(26)00142-6. Online ahead of print. PMID 42413526