Actively Recruiting
A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2026-03-03
400
Participants Needed
11
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of IN10018 and D-1553 compared to the standard anti-PD-1 monoclonal antibody therapy with platinum and pemetrexed for treating adults with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This phase III, randomized, open-label study is based on earlier data showing that IN10018 combined with D-1553 may enhance antitumor activity and delay resistance through multiple biological mechanisms. Participants are randomly assigned to one of two treatment groups. One group receives IN10018 100 mg orally once daily and D-1553 600 mg orally twice daily in 21-day cycles until disease progression or unacceptable side effects. The other group receives Tislelizumab 200 mg intravenously every 3 weeks combined with either Carboplatin or Cisplatin intravenously every 3 weeks for up to 4 cycles plus Pemetrexed intravenously every 3 weeks until disease progression. During the study, participants will have regular assessments to monitor tumor response, side effects, and survival. Key outcome measures include progression-free survival over 36 months, response rates, overall survival up to 60 months, and safety evaluations. The study aims to track disease control and duration of response while monitoring adverse events throughout the treatment period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent and comply with study requirements
- Histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
- Aged 18 to 80 years at the time of consent
- KRAS G12C mutation confirmed by central laboratory
- No prior systemic therapy for advanced or metastatic NSCLC
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 or 1
- Adequate organ function
- Life expectancy of at least 3 months as judged by Investigator
- Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment
You will not qualify if you...
- Other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)
- Active or untreated CNS metastases or carcinomatous meningitis
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors
- Presence of another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)
- Uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease needing systemic therapy
- History of another malignancy within 5 years except curatively treated low-risk cases
- Gastrointestinal conditions that may interfere with oral drug absorption
- Known active hepatitis B, hepatitis C, or HIV infection
- Receipt of live vaccine within 30 days before first dose
- Pregnant or breastfeeding women
- Psychiatric or substance abuse disorders interfering with study compliance
- Participation in another interventional clinical study
- Any condition judged by Investigator to interfere with participation or study results
Research Team
S
Shu Fang Project Manager, bachelor
J
Jack Zhang Clinical Trial Manager, bachelor
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