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New treatment option for Small Cell Lung Cancer Extensive Stage
Official title IN10018 Combination Therapy in Treatment-naïve ES-SCLC
ClinicalTrials.gov ID: NCT06030258
What this study is testing
What is IN10018?
IN10018 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for small cell lung cancer extensive stage.
Also referred to as BI 853520.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Has not received any systemic antitumor therapy for ES-SCLC.
- Has at least one measurable tumor lesion per RECIST 1.1.
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- people (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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, China
- Tianjin, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, China; Tianjin, China; Zhengzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.