OncoMatch/Clinical Trials/NCT06007937
A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer
Is NCT06007937 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Lorlatinib and Ramucirumab for non small cell lung cancer.
Treatment: Lorlatinib · Ramucirumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: ALK fusion
Disease stage
Required: Stage IV
Metastatic disease required
Metastatic or recurrent, biopsy-proven non-small cell lung cancer
Prior therapy
Must have received: second-generation ALK inhibitor (alectinib, brigatinib, ceritinib)
Patients in cohort 2 will have progressed or be intolerant of at least one second generation ALK TKI, including alectinib, brigatinib, or ceritinib. Patients may have received multiple ALK TKIs as well as chemotherapy, but one of these treatments must have been with a second-generation ALK TKI.
Cannot have received: ALK inhibitor (lorlatinib)
Prior lorlatinib or ramucirumab exposure
Cannot have received: VEGFR inhibitor (ramucirumab)
Prior lorlatinib or ramucirumab exposure
Lab requirements
Blood counts
ANC ≥1.5 × 10^9 /L, platelets ≥100 × 10^9/L, hemoglobin ≥ 9 g/dL
Kidney function
Cr ≤1.5 ULN or CrCl ≥ 40 mL/min. If Cr is ≥ 1.5x ULN, a 24-hr urine collection to calculate creatinine clearance must be performed
Liver function
total bilirubin ≤ 1.5 × ULN (Gilbert's syndrome: ≤2.0 × ULN and direct bilirubin within normal limits permitted), AST ≤ 3 × ULN, ALT ≤ 3 × ULN or ≤ 5 x ULN in the setting of liver metastases
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 times ULN and direct bilirubin within normal limits are permitted), AST ≤ 3 × ULN, ALT ≤ 3 × ULN or ≤ 5 x ULN in the setting of liver metastases, Cr ≤1.5 ULN or CrCl ≥ 40 mL/min. If Cr is ≥ 1.5x ULN, a 24-hr urine collection to calculate creatinine clearance must be performed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify