Combination therapy for treatment-naïve extensive stage small cell lung cancer

A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer

This study is testing a new combination of treatments for people with extensive-stage small cell lung cancer to see if it works better than the usual options.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: InxMed (Shanghai) Co., Ltd. (industry)
• Drugs / interventions: radiation, prednisone, Tislelizumab, chemotherapy
• Locations: 3 sites (Jinan and 2 other locations)
• Trial ID: NCT06030258 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label clinical study evaluates the efficacy, safety, and tolerability of IN10018 in combination with Tislelizumab, carboplatin, and etoposide as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The study consists of two phases: the first phase focuses on dose confirmation and pharmacokinetics, while the second phase assesses the antitumor efficacy compared to a control group receiving standard treatment. Participants will be monitored for safety and response to treatment throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed extensive-stage small cell lung cancer who have not received prior systemic therapy.

Not a fit: Patients with locally radical therapy options or those who have previously received systemic antitumor therapy for ES-SCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a more effective first-line treatment option for patients with extensive-stage small cell lung cancer.

How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in treating small cell lung cancer with immunotherapy and chemotherapy.

Eligibility criteria

Inclusion Criteria

1. Male or female aged 18-75 years old at the time of signing informed consent.
2. Be able to understand and be willing to sign informed consent.
3. Histologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group (VALG) staging system), which is not suitable for locally radical therapy.
4. Has not received any systemic antitumor therapy for ES-SCLC.
5. Has at least one measurable tumor lesion per RECIST 1.1.
6. Has an ECOG performance status of 0 or 1.
7. Estimated life expectancy is more than 3 months.
8. Has adequate organ function of bone marrow, liver, kidney, and coagulation. Relative laboratory tests must be performed within 7 days prior to first dose of study treatment/randomization.
9. AEs due to prior antitumor therapy must be recovered to ≤ Grade 1 (CTCAE v5.0) or a steady state as assessed by investigators
10. Subjects (male and female) with childbearing potential must agree to use contraception during the treatment phase and through 3 months after the last dose of study treatment.

Exclusion Criteria

1. Has known active or untreated central nervous system (CNS) metastases, and/or carcinomatous meningitis.
2. Spinal cord compression without surgery and/or radiation therapy, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 7 days prior to the first dose of study treatment/randomization.
3. Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.
4. Symptomatic hypercalcemia.
5. Malignancies other than the study disease within 3 years prior to the first dose of study treatment/randomization.
6. Have received palliative radiotherapy for bone metastasis within 14 days prior to the first dose of study treatment/randomization.
7. Have had allogeneic haematopoietic stem cell transplantation or organ transplantation.
8. History of active autoimmune disease required systemic treatment (including but not limited to drugs for disease control, corticosteroids, or immunosuppressive drugs) within the past 2 years.
9. Have an immunodeficiency disorder or have received systemic steroid therapy (prednisone or equivalent corticosteroid \> 10 mg/day) or other immunosuppressants within 7 days prior to the first dose of study treatment/randomization.
10. History of idiopathic pulmonary fibrosis, idiopathic pneumonia and organizing pneumonia, and interstitial pneumonitis or active pneumonia diagnosed per imaging examination at baseline.
11. Have had FAK inhibitors treatment.
12. Has a history of major cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment/randomization.
13. Have malabsorption syndrome or cannot take study drugs orally.
14. Any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
15. Active pulmonary tuberculosis
16. Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
17. Known hypersensitivity or allergy to IN10018, anti-PD-1/L1 monoclonal antibodies, carboplatin or etoposide or to their drug components.
18. Pregnant or lactating women or are expected to be pregnant or lactating during study treatment.

Where this trial is running

Jinan and 2 other locations

• Shandong Province Cancer Hospital — Jinan, China (RECRUITING)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (NOT_YET_RECRUITING)
• Henan Provincial People's Hospital — Zhengzhou, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Jun Zhao — Peking University Cancer Hospital & Institute
• Study coordinator: Shu Fang

Conditions: Small Cell Lung Cancer Extensive Stage, First-line