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.
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;
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;
Parallel
Lorlatinib
Druglorlatinib 100 mg orally once daily (QD)
sacituzumab tirumotecan plus lorlatinib
Druglorlatinib 100 mg orally once daily (QD) plus sacituzumab tirumotecan 4 mg/kg administered as an intravenous infusion on Day 1 and Day 15 of each 4-week cycle (Q4W) for 4 cycles
1-year PFS rate
PFS is defined as the time from the start of study treatment to the first documented radiographic disease progression or death from any cause, whichever occurs first (according to RECIST v1.1). The Kaplan-Meier method will be used to estimate the median PFS and its 95% confidence interval, to generate survival curves, and to calculate the 1-year PFS rate
PFS
PFS is defined as the time from the start of study treatment to the first documented radiographic disease progression or death from any cause, whichever occurs first (according to RECIST v1.1). The Kaplan-Meier method will be used to estimate the median PFS and its 95% confidence interval, to generate survival curves.
ORR
The objective response rate (ORR) is defined as the proportion of subjects in the analysis population who achieve a complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST version 1.1 criteria.
DCR
The disease control rate (DCR) is defined as the proportion of subjects who achieve complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to RECIST version 1.1 criteria.
TTR
Time to response (TTR) is defined as the interval from the first dose to the first documented complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1 criteria.
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