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A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer

A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers

NCT06007937•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

19 - No limit years

Sex

ALL

Healthy Volunteers

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 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
•°The patient's urinary protein is ≤1+ on dipstick or routine urinalysis (UA); if urine dipstick or routine analysis is ≥2+, a 24-hour urine collection for protein must demonstrate \<1000 mg of protein in 24 hours to allow participation in this protocol).
•Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin for a minimum of 14 days prior to trial enrollment without signs of active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor invading major vessels or known varices). Patients on warfarin must have an INR ≤ 3.0
+19 more criteria

Exclusion Criteria

•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
•Major surgery within 4 weeks of starting treatment on protocol or minor surgery/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy
•Less than 3 weeks since previous chemotherapy, 4 weeks since immunotherapy, and 2 weeks from any investigational therapy
•Significant bleeding disorders or grade ≥3 bleeding episode within 12 weeks prior to enrollment. Patients with history of gross hemoptysis (defined as bright red blood of ≥1/2 teaspoon) within 8 weeks prior to enrollment will be excluded

Locations (6)

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering West Harrison (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

Key Dates

Start Date

August 17, 2023

Primary Completion Date

August 17, 2028

Completion Date

August 17, 2028

Last Updated

February 5, 2026

Enrollment

ESTIMATED participants

Conditions

Non Small Cell Lung CancerMetastaticRecurrent

Interventions

Lorlatinib

DRUG

Ramucirumab

DRUG

Contacts

Gregory Riely, MD, PhD

CONTACT

646-608-3913 rielyg@mskcc.org

Alexander Drilon, MD

CONTACT

646-608-3758

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer

Inclusion Criteria

Exclusion Criteria

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors