Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensi… (NCT07501169) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
China33 participantsStarted 2026-04-01
Plain-language summary
This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients.
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.Voluntary participation with written informed consent obtained prior to any study-specific procedures.
* 2.Age ≥ 18 years and ≤ 75 years, regardless of sex.
* 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 4.Life expectancy of at least 3 months.
* 5.Histologically or cytologically confirmed small cell lung cancer (SCLC) based on pathology and immunohistochemistry/immunophenotyping results; disease staged as extensive-stage SCLC (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) staging system.
* 6.Disease progression (at the time of enrollment) after at least two cycles of platinum-based systemic therapy with or without PD-1/L1 inhibitors; no more than two prior lines of therapy.
Note: Adjuvant therapy is considered one prior line if disease progression occurs during treatment or within 6 months of the last adjuvant dose.
* 7.At least one measurable lesion as defined by RECIST version 1.1. Lesions previously treated with local therapy may be considered target lesions only if progression has been clearly documented at that site post-treatment. Brain lesions as sole target lesions are not acceptable.
* 8.Adequate bone marrow function without transfusion or growth factor support within 14 days prior to screening: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
* 9.Adequate hepatic function: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), o…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.