A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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 criteria
Qualifiers
Written informed consent
Age >18 years old
Metastatic or recurrent, biopsy-proven non-small cell lung cancer
ALK fusion identified by next generation sequencing (NGS) or IHC on material obtained from tumor or plasma
Disqualifiers
Prior lorlatinib or ramucirumab exposure
Symptomatic, unstable brain metastasis requiring therapy with steroids or radiation therapy. Patients with clinically stable brain metastases (previously treated or untreated) are eligible
Women who are breastfeeding or pregnant
Major radiotherapy within 2 weeks of starting treatment on protocol
Trial design
Treatments tested in this trial
- Lorlatinib
- Ramucirumab
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov