Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung C… (NCT07632209) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment
46 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1: Aged 18-75 years, without gender restriction.
2: 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.
3: Has received at least two lines of prior systemic antitumor therapy.
4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.
5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6: 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.
7: Expected survival time ≥ 3 months.
8: Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.
Exclusion Criteria:
* 1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.
2: Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is for small cell lung cancer that has already stopped responding to second-line treatment or beyond — given where I am in my treatment journey, is this trial's eligibility something my care team thinks fits my current situation?
2Since this is a Phase 2 trial combining lomustine with anlotinib, what do we currently know about the safety profile of using these two drugs together, and what side effects should I be most prepared for?
3The trial hasn't started recruiting yet — how long might it realistically be before it opens, and is waiting for it the right move, or are there other options I should be pursuing in the meantime?
4The main thing this trial is measuring is objective response rate, meaning whether the tumor shrinks — but how does that translate into what it might mean for my quality of life or how long I might live?
5Lomustine is an older chemotherapy drug while anlotinib is a newer targeted therapy — can you explain why combining them makes scientific sense for resistant extensive-stage small cell lung cancer, and how this approach compares to other salvage treatments that might already be available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: 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