IN10018 Combination Therapy in Treatment-naïve ES-SCLC

Inclusion criteria

• Male or female aged 18-75 years old at the time of signing informed consent.
• Be able to understand and be willing to sign informed consent.
• Histologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group (VALG) staging system), which is not suitable for locally radical therapy.
• Has not received any systemic antitumor therapy for ES-SCLC.
• Has at least one measurable tumor lesion per RECIST 1.1.
• Has an ECOG performance status of 0 or 1.
• Estimated life expectancy is more than 3 months.
• 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.
• AEs due to prior antitumor therapy must be recovered to ≤ Grade 1 (CTCAE v5.0) or a steady state as assessed by investigators
• 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

• Has known active or untreated central nervous system (CNS) metastases, and/or carcinomatous meningitis.
• 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.
• Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.
• Symptomatic hypercalcemia.
• Malignancies other than the study disease within 3 years prior to the first dose of study treatment/randomization.
• Have received palliative radiotherapy for bone metastasis within 14 days prior to the first dose of study treatment/randomization.
• Have had allogeneic haematopoietic stem cell transplantation or organ transplantation.
• 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.
• 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.
• History of idiopathic pulmonary fibrosis, idiopathic pneumonia and organizing pneumonia, and interstitial pneumonitis or active pneumonia diagnosed per imaging examination at baseline.
• Have had FAK inhibitors treatment.
• Has a history of major cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment/randomization.
• Have malabsorption syndrome or cannot take study drugs orally.
• Any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
• Active pulmonary tuberculosis
• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
• Known hypersensitivity or allergy to IN10018, anti-PD-1/L1 monoclonal antibodies, carboplatin or etoposide or to their drug components.
• Pregnant or lactating women or are expected to be pregnant or lactating during study treatment.