Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment

NCT07632209 | Not Yet Recruiting Phase 2

• 2 other identifiers: 2026LY0102MR-31-26-032631
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.

Conditions

SCLC, Extensive Stage

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib

  Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months

Secondary Outcomes (4)

• progression free survival

  Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months

• Disease Control Rate (DCR)

  Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first，assessed up to approximately 24 months

• Adverse Event (AE)

  From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months

• Quality of Life Score（QOL Score）

  At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months

Study Arms (1)

lomustine combined with anlotinib

EXPERIMENTAL

Oral lomustine 60 mg/m² once daily on day 1 every 6 weeks, combined with oral anlotinib. The initial dose of anlotinib is determined by the investigator, with optional doses of 12 mg, 10 mg or 8 mg once daily on days 1 to 14 every 3 weeks.

Drug: Lomustine; Drug: Anlotinib

Interventions

Lomustine DRUG

Oral lomustine 60 mg/m² once daily on day 1, every 6 weeks

lomustine combined with anlotinib

Anlotinib DRUG

Oral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle

lomustine combined with anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Aged 18-75 years, without gender restriction.
• : Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), classified as extensive-stage disease according to the Veterans Administration Lung Study Group (VALSG) staging system.
• : Has received at least two lines of prior systemic antitumor therapy.
• : Has at least one measurable lesion as defined by RECIST 1.1 criteria.
• : Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• : Adequate organ function meeting the following criteria: Hematological function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 100×10⁹/L; hemoglobin (Hb) ≥ 90 g/L. Hepatic and renal function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); serum creatinine (Cr) ≤ 1.5×ULN; estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m². Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
• : Expected survival time ≥ 3 months.
• : Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.

You may not qualify if:

• : Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.
• : Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy).
• : Active bleeding or high bleeding risk (e.g., history of massive gastrointestinal hemorrhage or cerebral hemorrhage within the past 6 months, or presence of unhealed wounds or ulcers).
• : Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or severe cardiovascular diseases (e.g., myocardial infarction, severe arrhythmia, heart failure within the past 6 months).
• : Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases).
• : Pregnant or lactating females. Female participants must use effective contraception during treatment and for 6 months after the last dose of study treatment; male participants must use effective contraception during treatment and for 3 months after the last dose of study treatment.
• : History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and other cured malignancies.
• : Known hypersensitivity to lomustine, anlotinib, or any excipient in their formulations.
• : Any other condition deemed inappropriate for participation in this study by the investigator (e.g., mental disorders, inability to comply with follow-up procedures).

Sponsors & Collaborators

• Yayi He: lead

MeSH Terms

Interventions

Lomustine; anlotinib

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study with no masking applied to any parties involved in the trial.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single-center, single-arm, open-label, non-randomized, exploratory interventional study.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05