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Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma

NCT06858410 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-05

No results posted yet for this study

Summary

The project is a Phase III, randomized, open-label, multicenter study in which approximately 36 patients with unresectable Stage III ALK positive Lung Adenocarcinoma will be randomized 1:1 to receive lorlatinib or concurrent/sequential platinum-based chemoradiotherapy

Conditions

  • Neoadjuvant Non-Small Cell Lung Cancer

Interventions

DRUG

lorlatinib

Eligible patients will be registered to receive oral lorlatinib 100mg qd for 36 months during the treatment phase.

OTHER

concurrent/sequential platinum-based chemoradiotherapy

The choice of chemotherapy and will be determined by the investigator prior to treatment allocation and the radiotherapy also according to the clinical therapy regimen decided by the investigator.

Sponsors & Collaborators

  • Guangdong Association of Clinical Trials

    lead OTHER

Principal Investigators

  • E E Ke, M.D. · 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
2025-03-31
Primary Completion
2030-03-31
Completion
2030-08-31

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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 NCT06858410 on ClinicalTrials.gov