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ALK Inhibitor

Lorlatinib + Ramucirumab for Lung Cancer

Q: To what extent is the population participating in this research endeavor?

Affirmative. Clinicaltrials.gov attests that this clinical trial, which was made available on 8/17/2023 is actively recruiting. A total of 56 participants are required from 6 distinct medical services sites.

Q: Are there any vacancies at present for this clinical trial?

Affirmative, according to clinicaltrials.gov the experiment is still enrolling volunteers. This study was initiated on August 17th 2023 and has been recently updated with the same date. The trial needs 56 participants from 6 sites elsewhere in the country.

Q: Are there any locations in North America currently conducting this clinical trial?

This trial is currently being conducted at 6 different medical locations, such as Montvale, Commack and Harrison. Participants should select the nearest site to reduce travel requirements.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Ramucirumab

2017

Completed Phase 3

~5050

Lorlatinib

2018

Completed Phase 4

~440

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,842 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,620 Previous Clinical Trials

3,216,543 Total Patients Enrolled

Gregory Riely, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

62 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the population participating in this research endeavor?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was made available on 8/17/2023 is actively recruiting. A total of 56 participants are required from 6 distinct medical services sites."

Answered by AI

Are there any vacancies at present for this clinical trial?

"Affirmative, according to clinicaltrials.gov the experiment is still enrolling volunteers. This study was initiated on August 17th 2023 and has been recently updated with the same date. The trial needs 56 participants from 6 sites elsewhere in the country."

Answered by AI

Are there any locations in North America currently conducting this clinical trial?

"This trial is currently being conducted at 6 different medical locations, such as Montvale, Commack and Harrison. Participants should select the nearest site to reduce travel requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007937.