A Randomized, Open-label, Multicenter, Phase III Study of Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy As Definitive Treatment in Patients with Locally Advanced, Unresectable Stage III ALK Positive Lung Adenocarcinoma

NCT06858410 Phase 3 NOT_YET_RECRUITING

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

Details

Lead sponsor	Guangdong Association of Clinical Trials
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	36
Start date	2025-03
Completion	2030-08

Conditions

• Neoadjuvant Non-Small Cell Lung Cancer

Interventions

• lorlatinib
• concurrent/sequential platinum-based chemoradiotherapy

Primary outcomes

• Progression Free Survival (PFS) — up to 36 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
  Progression Free Survival (PFS) is defined as the time from start of lorlatinib treatment to the date of disease progression as defined by RECIST v1.1 per investigator review or death due to any cause, whichever occurred first