Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2023-10-30
2025-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
IN10018
orally taken once daily
Tislelizumab
200mg D1, Q3W, intravenously
Carboplatin
AUC 5 mg/ml/min, D1, Q3W, intravenously
Etoposide
Etoposide 100 mg/m2, D1-D3, Q3W, intravenously
Control group
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
Tislelizumab
200mg D1, Q3W, intravenously
Carboplatin
AUC 5 mg/ml/min, D1, Q3W, intravenously
Etoposide
Etoposide 100 mg/m2, D1-D3, Q3W, intravenously
Interventions
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IN10018
orally taken once daily
Tislelizumab
200mg D1, Q3W, intravenously
Carboplatin
AUC 5 mg/ml/min, D1, Q3W, intravenously
Etoposide
Etoposide 100 mg/m2, D1-D3, Q3W, intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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InxMed (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jun Zhao
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Shandong Province Cancer Hospital
Jinan, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yuping Sun
Role: primary
Peng Chen
Role: primary
Shundong Cang
Role: primary
Other Identifiers
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IN10018-019
Identifier Type: -
Identifier Source: org_study_id
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