Actively Recruiting
A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-08
56
Participants Needed
6
Research Sites
261 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age greater than 18 years
- Metastatic or recurrent non-small cell lung cancer confirmed by biopsy
- ALK fusion identified by next generation sequencing or immunohistochemistry
- Measurable tumor lesion not previously treated with radiation
- Karnofsky performance status of 70% or higher
- Adequate organ function including specific blood counts and liver and kidney tests
- Stable full-dose anticoagulation use if applicable, with no active bleeding
- Recovery from prior therapy side effects except minor alopecia or peripheral neuropathy
- Cohort 1: no prior metastatic treatment; adjuvant chemotherapy allowed
- Cohort 2: progressed on or intolerant to at least one second-generation ALK tyrosine kinase inhibitor
- At least one prior treatment with a second-generation ALK tyrosine kinase inhibitor
- Use of effective contraception or postmenopausal status for sexually active patients
- Negative pregnancy test within 7 days before starting treatment for women of childbearing potential
You will not qualify if you...
- Previous treatment with lorlatinib or ramucirumab
- Symptomatic or unstable brain metastases needing steroids or radiation
- Pregnant or breastfeeding women
- Major radiotherapy within 2 weeks before starting treatment
- Major surgery within 4 weeks or minor surgery within 7 days before starting treatment
- Less than 3 weeks since last chemotherapy, 4 weeks since immunotherapy, or 2 weeks since investigational therapy
- Significant bleeding disorders or major bleeding events within 12 weeks before enrollment
- Recent deep vein thrombosis, pulmonary embolism, or other significant clotting events within 12 weeks
- Gastrointestinal perforation, fistula, or bowel obstruction within 6 months or high risk for perforation
- Moderate to severe liver cirrhosis or related complications
- Uncontrolled high blood pressure despite treatment
- Serious or non-healing wounds, ulcers, or fractures within 28 days before enrollment
- Evidence of major blood vessel invasion or tumor cavitation
- Active serious infections requiring intravenous antibiotics or known active viral infections
- Serious arterial thrombotic events within 6 months before enrollment
- Planned elective or major surgery during the trial
- Recent use of antiplatelet agents except aspirin up to 325 mg/day
- Serious uncontrolled medical or psychological conditions impacting study participation
- Use of strong CYP3A inducers or inhibitors that cannot be avoided
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
2
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
4
Memorial Sloan Kettering West Harrison (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
6
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States, 11570
Actively Recruiting
Research Team
G
Gregory Riely, MD, PhD
CONTACT
A
Alexander Drilon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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