← Back to Search

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
Select...
I have had at least one treatment for stage IV or recurrent non-small cell lung cancer.
Select...
My cancer spread has been treated and stable for at least 3 days after targeted or 14 days after full brain radiation.
Select...
My cancer does not have any known genetic changes that can be targeted by specific treatments.
Select...
I have recovered from previous treatment side effects, except for hair loss or skin color loss.

Timeline

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
Computed Tomography
2017
Completed Phase 2
~2740
Ramucirumab
2017
Completed Phase 3
~5050
Lymphoscintigraphy
2012
Completed Phase 2
~530
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 3
~2020
Tepotinib
2018
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
396 Previous Clinical Trials
265,396 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,887 Previous Clinical Trials
41,020,957 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,658 Previous Clinical Trials
3,225,114 Total Patients Enrolled
~37 spots leftby May 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top