Trials / Completed
CompletedNCT03909971
A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China
A PHASE 2, MULTI-CENTER, OPEN-LABEL, DUAL-COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LORLATINIB (PF-06463922) MONOTHERAPY IN ALK INHIBITOR-TREATED LOCALLY ADVANCED OR METASTATIC ALK-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS IN CHINA
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2, multi center, open label, dual cohort study to evaluate the efficacy and safety of lorlatinib (PF 06463922) monotherapy in ALK inhibitor treated locally advanced or metastatic ALK positive non small cell lung cancer patients in China
Detailed description
This is a Phase 2, China only, multi center, open label, dual cohort study, in ALK positive locally advanced or metastatic NSCLC patients will be enrolled to receive lorlatinib monotherapy. * (in Cohort 1) Disease progression after crizotinib as the only ALK inhibitor. * (in Cohort 2) Disease progression after one ALK inhibitor other than crizotinib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lorlatinib | ALK inhibitor-treated ALK-positive NSCL treatment |
Timeline
- Start date
- 2019-04-28
- Primary completion
- 2020-08-10
- Completion
- 2024-10-21
- First posted
- 2019-04-10
- Last updated
- 2025-11-05
- Results posted
- 2021-10-26
Locations
21 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03909971. Inclusion in this directory is not an endorsement.