A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer

A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer
Experimental: Lorlatinib and ramucirumab

The phase 1 safety portion of the study will assess whether a dose of lorlatinib 100 mg orally daily and ramucirumab 10 mg/kg intravenous infusion once every three weeks is a tolerable and safe dose. Six patients will be enrolled at this dose level and assessed for dose limiting toxicities (DLTs) for one full cycle (21 days). Once the phase 1 portion of the study is complete, patients will be enrolled in the phase 2 portion of the study, cohort expansion at the MTD. Patients will be enrolled in two patient cohorts: cohort 1, treatment-naïve and cohort 2, patients who have progressed on prior second-generation ALK TKI. A cycle will be 21 days in length. Response to therapy will initially be assessed by interval imaging every 2 cycles.

Drug: Lorlatinib

Lorlatinib 100 mg orally daily

Drug: Ramucirumab

Ramucirumab 10 mg/kg intravenous infusion once every three weeks is a tolerable and safe dose.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

September 5, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
Comments