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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Association of Clinical Trials

About this trial

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

Eligibility criteria

Qualifiers

Study Population: Patients with histologically or cytologically confirmed diagnosis of ALK-positive, lung adenocarcinoma who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer [IASLC]).

Tumor Requirements: At least 1 measurable target lesion per RECIST v. 1.1

Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1. Life expectancy at least 12weeks at Day1.

Age ≥18 years.

Disqualifiers

Previously received any ALK-TKIs or any thoracic radiotherapy

Active infection, including Bacteria, fungi or viruses

Any evidence of severe or uncontrolled systemic diseases, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol

Inadequate bone marrow reserve or organ function.

Trial design

Treatments tested in this trial

  • lorlatinib
  • concurrent/sequential platinum-based chemoradiotherapy

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

This trial has no locations