Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti-PD-1/L1 Therapy

NCT07022301 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-ethics-48
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.

Conditions

Small Cell Lung Cancer Extensive Stage; Resistance to Immunotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  the rate of patients with PR and CR

  24 months

Secondary Outcomes (3)

• OS

  24 months

• PFS

  24 months

• AE

  24 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Drug: Sintilimab combined with anlotinib

Drug: sintilimab combined with anlotinib

Interventions

sintilimab combined with anlotinib DRUG

Patients who met the inclusion criteria were treated with Sintilimab plus anlotinib every 3 weeks until disease progression or intolerable adverse reactions or death(up to 24 months).

Experimental arm

Eligibility Criteria

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

You may qualify if:

• \. At the time of signing the informed consent form, both men and women must be at least 18 years old.
• \. Widespread recurrent small cell lung cancer diagnosed by histology or cytology and progressing after 3 months of standard immunization.
• \. According to RECIST 1.1 criteria, patients must have at least one measurable lesion (lesions that have undergone radiotherapy must show clear progression in order to be considered measurable lesions).
• \. ECOG PS score: 0-1 points.
• \. Expected survival period ≥ 3 months.
• \. Important organ functions must meet the following standards:
• \) Blood routine examination: (No blood transfusion or use of cytokine drugs such as G-CSF for corrective treatment within 2 weeks before screening)
• Hemoglobin (HB) ≥ 90 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\*9/L;
• Platelet count (PLT) ≥ 90 × 10\*9/L;
• White blood cell count (WBC) ≥ 3.0 × 109/L and\<15 × 10\*9/L; 2) Other tests: (did not receive human serum albumin injection within 14 days before screening)
• AST and ALT ≤ 3 x ULN;
• ALP ≤ 2.5 x ULN (≤ 5 x ULN if there is bone metastasis);
• TBiL≤1x ULN；
• ALB≥30g/L；

You may not qualify if:

• \. Imaging shows that the tumor has invaded large blood vessels or has unclear boundaries with blood vessels.
• \. Imaging shows the presence of obvious pulmonary hollow or necrotic tumors.
• \. Symptomatic central nervous system metastases (such as brain metastases or meningeal metastases).
• \. Patients with conditions such as malignant meningitis and spinal cord compression.
• \. Persons who have suffered from other malignant tumors in the past or at the same time, unless they are skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, cervical carcinoma in situ or other carcinoma in situ that have achieved complete remission at least 5 years before screening and do not need or are not expected to need other treatment during the study period.
• \. Those who have had or currently have objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonitis (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, or screening period CT showing active pneumonia or lung function examination confirming severe impairment of lung function.
• \. Individuals with any active, known or suspected autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitary inflammation, hyperthyroidism, etc.). Type I diabetes patients who are allowed to receive stabilizing dose insulin treatment, hypothyroidism patients who only need hormone replacement treatment, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and have no acute deterioration within 1 year before the screening period.
• \. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention.
• \. Patients with hypertension who cannot achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
• \. Urine routine showed urinary protein ≥++, and 24-hour urinary protein quantification was confirmed to be\>1.0 g through quantitative detection of urinary protein.
• \. For individuals with a tendency towards thrombosis or undergoing thrombolytic/anticoagulant therapy, prophylactic use of low-dose aspirin (≤ 100mg/d) and low molecular weight heparin (≤ 40mg/d) is allowed.
• \. Within the first 6 months of randomization, there have been arterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
• \. Individuals with a daily cough/hemoptysis volume greater than 2.5mL within the first month of randomization. Individuals with a history of hereditary or acquired bleeding or coagulation dysfunction. Within the first 3 months of randomization, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc.
• \. Participants who have experienced severe infections within the previous month prior to randomization, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc; Subjects with any active infection, or experiencing unexplained fever\>38.5 ℃ during screening or before the first dose.
• \. Patients who have received anti-tumor vaccines or other immunomodulatory drugs (such as interleukin-2, thymosin, shiitake polysaccharides, etc.) within the previous month of randomization, or patients who will receive attenuated live vaccines.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

Related Links

• Related Info

MeSH Terms

Interventions

anlotinib

Central Study Contacts

Yiping Zhu

CONTACT

0553-5738279; zhuyiping@wnmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06