A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers
Memorial Sloan Kettering Cancer Center
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
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Measurable (RECIST 1.1) indicator lesion not previously irradiated * Karnofsky performance status (KPS) ≥ 70% * Adequate organ function defined as follows: ANC ≥1.5 × 10\^9 /L, platelets ≥100 × 10\^9/L, hemoglobin ≥ 9 g/dL, INR ≤ 1.5, PTT or aPTT \<1.5x ULN, total bilirubin ≤ 1.5 × ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2.0 tim…
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
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)Commack, New York
- Memorial Sloan Kettering West Harrison (All Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York
- Memorial Sloan Kettering Nassau (All Protocol Activities)Rockville Centre, New York