Study on Lorlatinib and Ramucirumab Combination for Lung Cancer

Inclusion Criteria

• Must provide written consent to participate.
• Be over 18 years old.
• Have lung cancer that has spread or returned, confirmed by a biopsy.
• Have a specific genetic change in the cancer, identified by tests on tumor or blood samples.
• Have at least one tumor that can be measured and has not been treated with radiation.
• Be in good general health, with a performance status score of 70% or higher.
• Have adequate organ function based on specific blood test results.
• If on blood thinners, must be on a stable dose for at least 14 days before joining the trial.
• Must have recovered from any side effects of previous treatments, except for hair loss or mild nerve damage.
• For one group, must not have had treatment for cancer that has spread. Previous chemotherapy is allowed.
• For another group, must have tried and not responded to or tolerated at least one second-generation ALK inhibitor.
• Must use effective birth control if sexually active, as the effects of ramucirumab on pregnancy are unknown.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

• Have previously taken lorlatinib or ramucirumab.
• Have unstable brain cancer that needs treatment with steroids or radiation.
• Be pregnant or breastfeeding.
• Have had major radiation therapy within 2 weeks of starting the study.
• Have had major surgery within 4 weeks or minor surgery within 7 days before starting the study.
• Have had chemotherapy within 3 weeks, immunotherapy within 4 weeks, or any experimental treatment within 2 weeks before starting the study.
• Have significant bleeding disorders or recent major bleeding.
• Have had blood clots in the last 12 weeks, unless stable on blood thinners.
• Have had gastrointestinal perforation or fistula within 6 months.
• Have significant liver disease or uncontrolled high blood pressure.
• Have serious wounds or fractures that are not healing.
• Have cancer invading major blood vessels or cavities in tumors.
• Have active infections requiring IV antibiotics.
• Have had recent heart attacks, strokes, or severe heart failure.
• Plan to have major surgery during the study.
• Be on certain medications that affect blood clotting or liver enzymes.
• Have serious medical or psychological conditions that could interfere with the study.