NCT06007937

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

A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety of the combination of ramucirumab and lorlatinib. The researchers will test one or two different doses of lorlatinib in combination with ramucirumab to find the drug combination dose that causes few or mild side effects in participants. Once the researchers find this dose, they can test it in future participants to see if it is effective in treating their metastatic ALK-rearranged NSCLC. The researchers are also looking to see whether there are specific genes or DNA sequences associated with a response to treatment with lorlatinib and ramucirumab.

Conditions

• Non Small Cell Lung Cancer
• Metastatic
• Recurrent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-17
• Primary completion: 2028-08-17
• Completion: 2028-08-17
• First posted: 2023-08-23
• Last updated: 2026-04-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study