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Small Cell Lung CancerPhase 4NCT06951841

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

A Phase 4 study testing Liposome Irinotecan, Platinum and Tislelizumab in people with Small Cell Lung Cancer, run by China Medical University, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Liposome Irinotecan, Platinum and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
30 Apr 2025to 30 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Female participants had to agree not to breastfeed during the study period or for 180 days after the last dose of study treatment

Who cannot join

  • 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
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  • 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
  • Major surgery, open biopsy, or significant trauma were performed within 28 days prior to enrollment
  • Aortic/venous thrombosis occurred within 6 months
  • The researchers assessed possible risk of severe hemoptysis, bleeding events, or wearing
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Pregnant or lactating women; Fertile patients who are unwilling or unable to use effective contraception
  • Allergic reaction to any investigational drug or its ingredients
  • Any condition that the investigator believes is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yunpeng Liu contact

13898865122

cmuliuyunpeng@hotmail.com

China1 site

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

Other trials in China

About this study

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

Read the detailed description
  1. Irinotecan hydrochloride liposome injection combined with platinum and tislelizumab therapy in a 3-week treatment cycle , 4 cycles Drug: Liposome irinotecan(50mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle 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 Drug: Tislelizumab (200mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle
  2. Maintenance treatment, to disease progression or AE Drug: Tislelizumab (200mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle 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
Being tested
Liposome Irinotecan, Platinum, Tislelizumab, Anlotinib
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposome IrinotecanDrug

    Also called duoenyi

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

  • PlatinumDrug

    Also called Carboplatin/Cisplatin

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

  • TislelizumabDrug

    Also called immune checkpoint inhibitors

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

  • AnlotinibDrug

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

Study groups in NCT06951841
Study groupRoleWhat they receive
treatment groupExperimental1. 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
Receives: Drug: Liposome Irinotecan; Drug: Platinum; Drug: Tislelizumab; Drug: Anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 months

Secondary outcomes (4)

  1. Objective response rate (ORR)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 months

  2. Disease Control Rate (DCR)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 months

  3. overall survival (OS)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 12 months

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

    To identify the incidence of AE and SAE in clinical trial

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start30 Apr 2025 (estimated)
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06951841
Sponsor's protocol ID
CSPC-DEY-SCLC-LN01
Status last verified
Apr 2025
First submitted
23 Apr 2025
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposome Irinotecan, Platinum and Tislelizumab in people with Small Cell Lung Cancer, run by China Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yunpeng Liu (13898865122, cmuliuyunpeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: baseline up to approximately 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06951841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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