Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for … (NCT07750704) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLC
China153 participantsStarted 2026-09
Plain-language summary
This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of lorlatinib plus sacituzumab tirumotecan based on peripheral blood ctDNA as first-line treatment for ALK fusion NSCLC.
Who can participate
Age range
18 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
. Patients aged ≥ 18 years at the time of signing the informed consent, regardless of gender;
. Histologically/cytologically confirmed NSCLC, Stage III (locally advanced) or IV (metastatic), unsuitable for curative surgery and/or curative radiotherapy, with or without prior concurrent/sequential chemotherapy;
. No prior systemic therapy for locally advanced or metastatic NSCLC, patients previously treated with curative-intent adjuvant/neoadjuvant chemo or concurrent/sequential chemoradiotherapy for non-metastatic disease are eligible if progression occurred ≥ 12 months after the last treatment;
. Confirmation of ALK fusion by tumor histology, cytology, or blood-based testing;
. Patients must have at least one measurable lesion according to RECIST v1.1. Lesions that have been previously irradiated should not be selected as target lesions. Subjects with only skin lesions or bone lesions are not eligible for inclusion;
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.
What they're measuring
1
1-year PFS rate
Timeframe: From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 1 year.
. ECOG performance status score of 0 or 1 within 7 days prior to the first dose of study drug;
. Estimated survival of ≥ 12 weeks;
. Adequate organ and bone marrow function, without having received blood transfusion, recombinant human thrombopoietin, or colony-stimulating factors within 2 weeks prior to the first dose of study drug.
Exclusion criteria
. Histological or cytological confirmation of mixed small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma components;
. Prior receipt of any of the following therapies (including in the adjuvant or neoadjuvant setting): a) TROP2-targeted therapy; b) Any therapy containing topoisomerase I, including antibody-drug conjugate (ADC) therapy; c) Lorlatinib targeted therapy;
. Presence of factors affecting oral drug administration;
. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that precludes or delays corneal healing;
. Presence of spinal cord compression. Subjects who have received adequate local treatment (surgery or radiotherapy) and have clinical evidence of symptom relief for ≥ 1 week prior to the first dose may be enrolled;
. Presence of active central nervous system (CNS) metastases. Subjects with stable asymptomatic CNS metastases may be enrolled;
. Presence of other malignancy within 3 years prior to the first dose (except for tumors cured by local therapy or in situ carcinomas that do not require immediate treatment);
. Presence of severe cardiovascular or cerebrovascular disease or cardiovascular risk factors;