Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction

NCT06951841 | Not Yet Recruiting Phase 4

• 1 other identifier: CSPC-DEY-SCLC-LN01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of liposome irinotecan combined with platinum and immune checkpoint inhibitor combined with antirotinib maintenance therapy after first-line induction

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To evaluate the efficacy of anti-tumor

  baseline up to approximately 6 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  baseline up to approximately 6 months

• Disease Control Rate (DCR)

  baseline up to approximately 6 months

• overall survival (OS)

  baseline up to approximately 12 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From the initiation of the first dose to 14 days after the last dose

Study Arms (1)

treatment group

EXPERIMENTAL

1. Irinotecan hydrochloride liposome injection combined with platinum and tislelizumab therapy in a 3-week treatment cycle , 4 cycles 2. Maintenance treatment, to disease progression or AE

Drug: Liposome Irinotecan; Drug: Platinum; Drug: Tislelizumab; Drug: Anlotinib

Interventions

Liposome Irinotecan DRUG

Liposome irinotecan(50mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

Also known as: duoenyi

treatment group

Platinum DRUG

Carboplatin (AUC 4-5) or Cisplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

Also known as: Carboplatin/Cisplatin

treatment group

Tislelizumab DRUG

Tislelizumab (200mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

Also known as: immune checkpoint inhibitors

treatment group

Anlotinib DRUG

Anlotinib (8mg) will be administered orally in a 3-week treatment cycle, once a day from day 1 to day 14 of each cycle

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to join the study, sign the informed consent and sign the date, have good compliance, and cooperate with follow-up
• Age≥18 years
• Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed histologically or pathologically (according to American Veterans Lung Cancer Association, VALG staging)
• ECOG 0-2
• Subjects had not received any systemic treatment for ES-SCLC in the past (including chemotherapy, use of similar VEGFR inhibitors and immune checkpoint inhibitors, etc.)
• Subjects with limited-stage small cell lung cancer (LS-SCLC) have received radiotherapy, chemotherapy, or chemoradiotherapy for more than 6 months
• Expected survival ≥ 3 months
• Must have measurable target lesions that meet RECIST1.1 criteria (CT scan length of tumor lesion \>10mm); In patients with initial asymptomatic brain metastases, craniocerebral radiotherapy may be performed during induction chemotherapy
• If the major organs are functioning normally, the following criteria are met:
• Blood routine examination must meet (no blood transfusion within 14 days, no hematopoietic factor and no drug correction) : ANC ≥ 1.5×10\^9/L; HB ≥ 90 g/L; PLT ≥ 100×10\^9/L
• Biochemical examination must meet the following criteria: TBIL ≤ 1.5ULN; ALT and AST≤ 2.5ULN;
• Renal function must meet the following criteria: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min (using the standard Cockcroft-Gault formula)
• Coagulation function must meet: INR≤1.5 and APTT≤1.5ULN
• Female who are fertile must have a serum or urine pregnancy test within 72 hours before the first medication and the result is negative. Fertile female and male subjects whose partners are fertile female must agree to a highly effective method of avoiding and breastfeeding during the study period until 90 days after the last dose of the study drug. The investigator or designee, in consultation with the subject, shall confirm that the subject understands the proper and consistent use of contraceptive methods
• For males, they should be surgically sterilized or consent to a highly effective method of avoidance during the trial and for 90 days after the last administration of the experimental drug

You may not qualify if:

• Patients with meningeal metastases or symptomatic brain metastases
• Previous T cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other targeting T cell drugs;
• Past treatment with anlotinib
• Factors affecting oral medication, such as inability to swallow, post-GI resection, chronic diarrhea, intestinal obstruction, etc
• Uncontrollable pleural effusion or ascites
• Have any active autoimmune disease or history of autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Patients with skin conditions (such as vitiligo, psoriasis, or alopecia) that have been in complete remission from childhood asthma and do not require any intervention in adulthood and do not require systemic treatment may be included. Patients who require medical intervention with bronchodilators may not be included
• Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C
• Urine routine suggests urinary protein ≥(++), or 24h urinary protein ≥2g or severe hepatic and renal insufficiency
• Patients requiring systemic therapy with corticosteroids (\>10mg/ day of prednisone or equivalent) or other immunosuppressants within 14 days prior to initial medication. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses \>10 mg/ day of prednisone efficacy
• Patients who have been treated with anti-tumor vaccine or other immunostimulating anti-tumor agents (interferon, interleukin, thymosin, immunocell therapy, etc.) within 1 month prior to initial medication
• Other malignant neoplasms were present within 5 years prior to admission, except for adequately treatable carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery
• There is evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, radiologically proven active pneumonia, and severe impairment of lung function
• Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90mmHg, despite optimal medical treatment
• Patients with grade II or higher myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in women). According to the NYHA criteria, patients with grade III to Ⅳ cardiac insufficiency, or those with left ventricular ejection fraction (LVEF) \< 50% indicated by color Doppler ultrasound had myocardial infarction in the 6 months prior to enrollment, heart failure of New York Heart Society grade II or above, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, and myocardial infarction. Or electrocardiogram suggests acute ischemia or abnormal active conduction system
• Concurrent severe infection within 4 weeks prior to first dosing, or unexplained fever \>38.5°C during screening/prior to first dosing

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Platinum; Carboplatin; Cisplatin; tislelizumab; Immune Checkpoint Inhibitors; anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Yunpeng Liu

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Liu

CONTACT

13898865122; cmuliuyunpeng@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)