Status:
RECRUITING
IN10018 Combination Therapy in Treatment-naïve ES-SCLC
Lead Sponsor:
InxMed (Shanghai) Co., Ltd.
Conditions:
Small Cell Lung Cancer Extensive Stage
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antib...
Detailed Description
This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the PK parameters, safety and recommended phase II dose (RP2D) of IN10018 in combination with anti-PD-1/L1 monoclonal anti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06030258
Start Date
October 30 2023
End Date
December 24 2025
Last Update
April 30 2025
Active Locations (3)
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1
Shandong Province Cancer Hospital
Jinan, China
2
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
3
Henan Provincial People's Hospital
Zhengzhou, China