🏛️ Verified NIH Record • Updated 2026-08-12

A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer (NCT06007937)

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

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (22 items).

Location: Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey

Age range: 19 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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
  • New or history of diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE) or other significant thromboembolic event in the 12 weeks prior to first dose of protocol therapy. Patients with thromboembolic events diagnosed \>12 weeks prior to protocol therapy are eligible if on stable doses of anticoagulation as outlined above. Venous port or catheter thrombosis or superficial venous thrombosis are not considered significant events
  • GI perforation and/or fistula or bowel obstruction within 6 months or risk factors for perforation prior to enrollment
  • Child-Pugh B or greater cirrhosis or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
  • Uncontrolled hypertension, defined as systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg, prior to initiating study treatment, despite hypertensive intervention

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 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
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre, New York

📞 Contact the Study Coordinator

Phone: (800) 525-2225

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗