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Kinase Inhibitor

Tepotinib + Ramucirumab for Lung Cancer

Phase 2

Recruiting

Led By Paul K Paik

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC

Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization,

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from date of sub-study randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of drugs, tepotinib and ramucirumab, for treating patients with advanced non-small cell lung cancer that has spread or come back. Tepotin

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that has spread or returned, and have a specific gene change (MET Exon 14 skipping). They must have had at least one prior treatment, measurable disease by CT or MRI, no other major actionable mutations, and be stable after any brain metastases treatments. Participants need to show progression after the last therapy and can't have unresolved severe side effects from previous treatments.

What is being tested?

The study tests tepotinib alone or combined with ramucirumab in patients. Tepotinib is a kinase inhibitor targeting abnormal MET protein to slow tumor growth; ramucirumab aims to stop tumors from growing new blood vessels. The combination's effectiveness against stage IV or recurrent lung cancer is being evaluated.

What are the potential side effects?

Tepotinib may cause liver issues, fatigue, nausea, swelling of limbs/body parts due to fluid retention. Ramucirumab can lead to high blood pressure, bleeding problems, infusion-related reactions like fever/chills and potential risk of wound healing complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one treatment for stage IV or recurrent non-small cell lung cancer.

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My cancer spread has been treated and stable for at least 3 days after targeted or 14 days after full brain radiation.

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My cancer does not have any known genetic changes that can be targeted by specific treatments.

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I have recovered from previous treatment side effects, except for hair loss or skin color loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years from date of sub-study randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years from date of sub-study randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from date of sub-study randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

Duration of response

Frequency of treatment-related peripheral edema

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: (Ramucirumab and tepotinib)Experimental Treatment6 Interventions

Patients receive ramucirumab IV over 30-60 minutes on day 1 of each cycle and tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.

Group II: Arm B: (Tepotinib)Active Control5 Interventions

Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ramucirumab

2017

Completed Phase 3

~5050

Computed Tomography

2017

Completed Phase 2

~2790