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Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLC

NCT07750704 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • ALK Positive Non-small Cell Lung Cancer

Interventions

DRUG

Lorlatinib

lorlatinib 100 mg orally once daily (QD)

DRUG

sacituzumab tirumotecan plus lorlatinib

lorlatinib 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

Sponsors & Collaborators

  • Guangdong Association of Clinical Trials

    lead OTHER

Principal Investigators

  • Yi-Long Wu, MD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-09-30
Completion
2030-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07750704 on ClinicalTrials.gov