Lorlatinib + Ramucirumab for Lung Cancer
Trial Summary
The trial does not specify if you must stop all current medications, but you cannot take certain medications like antiplatelet agents or strong CYP3A inducers or inhibitors within 7 days of enrollment. If you're on full-dose anticoagulation, you must be on a stable dose for at least 14 days before joining the trial.
Research shows that Ramucirumab, when combined with other drugs, has shown some effectiveness in treating advanced non-small-cell lung cancer (NSCLC), improving survival in certain cases. Additionally, combining Ramucirumab with other targeted therapies has been used to overcome resistance in lung cancer treatments.
12345Ramucirumab, used in combination with other drugs for lung cancer, is generally tolerable but can cause serious side effects like low white blood cell counts, fever, high blood pressure, and bleeding. It's important for these side effects to be monitored and managed by healthcare professionals.
13567The combination of Lorlatinib and Ramucirumab for lung cancer is unique because it pairs Lorlatinib, a targeted therapy for specific genetic mutations in lung cancer, with Ramucirumab, an anti-angiogenic drug that blocks blood vessel growth in tumors. This combination aims to target cancer cells directly while also cutting off their blood supply, potentially offering a novel approach compared to standard treatments.
13567Eligibility Criteria
This trial is for adults over 18 with ALK-rearranged non-small cell lung cancer that's metastatic or recurrent. They must have specific gene fusions, measurable lesions not previously treated with radiation, and good organ function. Prior chemotherapy is okay if recovered from side effects (except mild neuropathy or hair loss). Participants need stable anticoagulation if applicable and can't be pregnant or breastfeeding. Those in cohort 2 must have tried a second-generation ALK inhibitor.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive lorlatinib 100 mg orally daily and ramucirumab 10 mg/kg intravenous infusion once every three weeks to assess safety and dose limiting toxicities
Phase 2 Treatment
Participants receive the maximum tolerated dose determined in Phase 1 to assess effectiveness in treating metastatic ALK-rearranged NSCLC
Follow-up
Participants are monitored for safety and effectiveness after treatment
Participant Groups
Lorlatinib is already approved in United States, European Union, Japan, Canada for the following indications:
- Metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement
- Advanced non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement
- Unresectable, advanced/recurrent non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement
- Metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement