A Phase 1/2 Study of Lorlatinib Plus Ramucirumab in People With Advanced Lung Cancer

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Full Title

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

Purpose

Researchers want to find the best dose of lorlatinib to give with ramucirumab in people with lung cancer. They are also seeing how well this drug combination works. The people in this study have non-small cell lung cancer (NSCLC) that has metastasized (spread). In addition, their cancers have a fusion involving the ALK gene. A fusion gene is made when parts of two different genes in your body join together.

Lorlatinib works to prevent cancer spread by interfering with cancer cell growth. Ramucirumab blocks a protein that can cause tumors to grow. Giving them together may be effective for treating NSCLC with ALK gene fusions. Lorlatinib is taken orally (by mouth) and ramucirumab is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have NSCLC that has metastasized and has an ALK gene fusion.
  • Have completed prior chemotherapy at least 3 weeks before getting the study treatment. Major surgery or immunotherapy must have finished at least 4 weeks before.
  • Not have previously had treatment with lorlatinib or ramucirumab.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Gregory Riely’s office at 646-608-3913.

Protocol

23-131

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06007937