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ALK Inhibitor

Lorlatinib + Ramucirumab for Lung Cancer

Phase 1 & 2
Recruiting
Led By Gregory Riely, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic or recurrent, biopsy-proven non-small cell lung cancer
Adequate organ function as defined: 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
Must not have
Less than 3 weeks since previous chemotherapy, 4 weeks since immunotherapy, and 2 weeks from any investigational therapy
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial will test the safety of a combination of drugs to treat metastatic ALK-rearranged NSCLC. Researchers will find the dose that causes few side effects, then test it in future participants to see if it works. They'll also look for genes associated with response.

Who is the study for?
This trial is for adults over 18 with ALK-rearranged non-small cell lung cancer that's metastatic or recurrent. They must have specific gene fusions, measurable lesions not previously treated with radiation, and good organ function. Prior chemotherapy is okay if recovered from side effects (except mild neuropathy or hair loss). Participants need stable anticoagulation if applicable and can't be pregnant or breastfeeding. Those in cohort 2 must have tried a second-generation ALK inhibitor.
What is being tested?
The study tests different doses of lorlatinib combined with ramucirumab to find the safest dose level for future trials on effectiveness against advanced lung cancer. It also explores genetic factors linked to treatment response.
What are the potential side effects?
Potential side effects include those common to cancer treatments such as fatigue, nausea, blood clotting issues, and possible reactions at infusion sites. The exact profile will be clearer once the safest dose is determined.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer has spread or come back and is confirmed by a biopsy.
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My blood tests show my organs are functioning well.
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I am able to care for myself but may not be able to do active work.
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My cancer has an ALK fusion found through specific testing.
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I have a tumor that can be measured and hasn't been treated with radiation.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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It's been less than 3 weeks since my last chemotherapy, 4 weeks since my last immunotherapy, and 2 weeks since any experimental treatment.
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I haven't had major surgery in the last 4 weeks or minor surgery in the last 7 days.
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I haven't had a GI perforation, fistula, or bowel obstruction in the last 6 months.
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I am planning to have a major surgery during the trial.
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I am not pregnant or breastfeeding.
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I have not had major radiotherapy in the last 2 weeks.
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I have previously been treated with lorlatinib or ramucirumab.
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My blood pressure is not controlled, even with treatment.
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I am not taking any strong medications that affect drug metabolism.
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My cancer is affecting major blood vessels or has caused holes in the tumor.
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I do not have an active serious infection or HIV with active hepatitis B or C.
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I have severe liver disease with complications like confusion or fluid in my abdomen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) (Phase I)
Progression-free survival (Phase II)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lorlatinib and ramucirumabExperimental Treatment2 Interventions
The phase 1 safety portion of the study will assess whether a dose of lorlatinib 100 mg orally daily and ramucirumab 10 mg/kg intravenous infusion once every three weeks is a tolerable and safe dose. Six patients will be enrolled at this dose level and assessed for dose limiting toxicities (DLTs) for one full cycle (21 days). Once the phase 1 portion of the study is complete, patients will be enrolled in the phase 2 portion of the study, cohort expansion at the MTD. Patients will be enrolled in two patient cohorts: cohort 1, treatment-naïve and cohort 2, patients who have progressed on prior second-generation ALK TKI. A cycle will be 21 days in length. Response to therapy will initially be assessed by interval imaging every 2 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorlatinib
2018
Completed Phase 4
~460
Ramucirumab
2017
Completed Phase 3
~5050

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,500 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,640 Previous Clinical Trials
3,221,588 Total Patients Enrolled
Gregory Riely, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
101 Total Patients Enrolled
~37 spots leftby Aug 2028
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