RecruitingPhase 1Phase 2NCT06007937

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

56 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding ramucirumab (a drug that blocks tumor blood vessel growth) to lorlatinib (a targeted therapy) can improve outcomes in patients with non-small cell lung cancer (NSCLC) that has an ALK gene rearrangement — a specific mutation that drives cancer growth. **You may be eligible if:** - You are over 18 years old - You have metastatic or recurrent NSCLC with a confirmed ALK gene rearrangement - You have at least one measurable tumor on imaging - You are in generally good health (Karnofsky score 70% or higher) - You are either treatment-naive in the metastatic setting (Cohort 1) or have progressed on at least one second-generation ALK inhibitor (Cohort 2) **You may NOT be eligible if:** - You have active or uncontrolled brain metastases - You have significant bleeding problems or recent blood clots - Your organ function (kidney, liver, blood) does not meet the required levels - You have not recovered from side effects of prior cancer treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLorlatinib

Lorlatinib 100 mg orally daily

DRUGRamucirumab

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


Locations(6)

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering West Harrison (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06007937