A Phase 2, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Lorlatinib Monotherapy in Crizotinib and Platinum-based Chemotherapy Treated Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer Subjects in China

NCT05297890 Phase 2 ACTIVE_NOT_RECRUITING

A Phase 2, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Lorlatinib Monotherapy in Crizotinib and Platinum-based Chemotherapy Treated Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)Subjects in China

Details

Lead sponsor	CStone Pharmaceuticals
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	70
Start date	2022-05-27
Completion	2026-05

Conditions

• Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

Interventions

• Lorlatinib

Primary outcomes

• Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Independent Central Radiology (ICR) assessment — From the date of first dose of first subject to 6 months after the first dose of last subject, assessed up to approximately 19 months

Countries

China