Actively Recruiting
A Phase Ib/II Trial Evaluating IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2025-04-30
120
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of IN10018 with an anti-PD-1/L1 antibody (Tislelizumab) and chemotherapy (carboplatin and etoposide) as a first treatment in people with extensive-stage small cell lung cancer (ES-SCLC). This open-label, randomized phase Ib/II study aims to assess the anti-tumor effects, safety, tolerability, and how the body processes IN10018 in this patient group. The study is sponsored by InxMed (Shanghai) Co., Ltd and aims to find the best dose and compare treatment effects over up to three years. The trial is divided into two parts: the first part to confirm the dose and safety of IN10018 combined with Tislelizumab, carboplatin, and etoposide; the second part to compare the experimental combination to the control group receiving Tislelizumab with carboplatin and etoposide. IN10018 is taken orally once daily, while Tislelizumab, carboplatin, and etoposide are given intravenously on a three-week cycle with specified doses and schedules. Participants will undergo assessments including tumor measurements, safety evaluations, and pharmacokinetic studies to monitor how the drug behaves in the body. Researchers will follow progression-free survival, response rates, duration of response, disease control, overall survival, and adverse events for up to three years. Eligibility includes adults aged 18 to 75 with confirmed ES-SCLC who have not received prior systemic therapy. The study involves regular visits for treatment administration, monitoring, and data collection throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
IN10018 Combination Therapy in Treatment-naïve ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-75 years old at the time of signing informed consent.
- Able to understand and willing to sign informed consent.
- Histologically confirmed extensive-stage small cell lung cancer (ES-SCLC) not suitable for locally radical therapy.
- No prior systemic antitumor therapy for ES-SCLC.
- At least one measurable tumor lesion per RECIST 1.1.
- ECOG performance status of 0 or 1.
- Estimated life expectancy of more than 3 months.
- Adequate organ function of bone marrow, liver, kidney, and coagulation with tests within 7 days prior to first dose.
- Adverse events due to prior antitumor therapy recovered to grade 1 or steady state.
- Agreement to use contraception during treatment and for 3 months after last dose if of childbearing potential.
You will not qualify if you...
- Known active or untreated central nervous system metastases or carcinomatous meningitis.
- Spinal cord compression without surgery or radiation, or unstable disease for at least 7 days prior to first dose.
- Clinically symptomatic pleural, pericardial, or abdominal effusion requiring drainage.
- Symptomatic hypercalcemia.
- Other malignancies within 3 years prior to first dose.
- Palliative radiotherapy for bone metastasis within 14 days prior to first dose.
- Prior allogeneic hematopoietic stem cell or organ transplantation.
- History of active autoimmune disease requiring systemic treatment within past 2 years.
- Immunodeficiency or recent systemic steroid or immunosuppressant therapy within 7 days prior to first dose.
- History of idiopathic pulmonary fibrosis, pneumonia, interstitial pneumonitis, or active pneumonia at baseline.
- Prior FAK inhibitors treatment.
- Major cardiovascular or cerebrovascular disease within 6 months prior to first dose.
- Malabsorption syndrome or inability to take oral study drugs.
- Active infection requiring systemic therapy within 14 days prior to first dose.
- Active pulmonary tuberculosis.
- HIV infection, active hepatitis B or C infection.
- Known allergy to study drugs or components.
- Pregnant or lactating women or expecting pregnancy during study treatment.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive a combination of drugs as first-line treatment for extensive-stage small cell lung cancer. This includes oral IN10018 taken once daily, and intravenous Tislelizumab, carboplatin, and etoposide administered every 3 weeks in cycles.
Repeated visits every 3 weeks for drug administration and monitoring
Trial Site Locations
Total: 3 locations
1
Shandong Province Cancer Hospital
Jinan, China
Actively Recruiting
2
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Not Yet Recruiting
3
Henan Provincial People's Hospital
Zhengzhou, China
Not Yet Recruiting
Research Team
S
Shu Fang
L
Lily Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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