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

ConditionsNon Small Cell Lung Cancer Metastatic Recurrent

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age19+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

Lorlatinib
Drug
Lorlatinib 100 mg orally daily
Ramucirumab
Drug
Ramucirumab 10 mg/kg intravenous infusion once every three weeks is a tolerable and safe dose.

Treatment groups

56 Participants

are divided into 1 treatment group

Group A: Lorlatinib and ramucirumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Maximum tolerated dose (MTD) (Phase I)

Dose limiting toxicities using the NCI Common Terminology Criteria for Adverse Events Version 5 (NCI-CTCAE) will be used to grade toxicities during the trial.

Time frame

1 year

Progression-free survival (Phase II)

by RECIST

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Eli Lilly and Company

Collaborator

Source ClinicalTrials.gov

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