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Monoclonal Antibodies

Pembrolizumab for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Karen L Reckamp
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
Patients must not have any history of organ transplant that requires use of immunosuppressives
Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to a maximum of 3 years or death
Awards & highlights

Study Summary

This trial is studying ramucirumab and pembrolizumab to see how well they work compared to standard of care in treating patients with non-small cell lung cancer.

Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer who have had one prior anti-PD-1/PD-L1 therapy. They must not be pregnant, nursing, or have certain mutations (EGFR, ALK, ROS 1, BRAF V600E) unless they've progressed after standard treatments. No active autoimmune diseases requiring recent treatment, no organ transplants needing immunosuppression, and no serious infections like tuberculosis are allowed.Check my eligibility
What is being tested?
The trial tests the combination of ramucirumab and pembrolizumab against standard chemotherapy drugs (docetaxel, gemcitabine hydrochloride, pemetrexed). It aims to see if this immunotherapy combo is more effective in stopping tumor growth compared to conventional treatments in patients with advanced non-small cell lung cancer.See study design
What are the potential side effects?
Possible side effects include immune system reactions that can affect organs; infusion-related symptoms; fatigue; gastrointestinal issues such as bleeding or perforation; blood clots; liver problems like hepatitis B/C flare-ups; and increased risk of infection due to HIV.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had an organ transplant requiring immunosuppressives.
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My cancer does not have specific genetic changes or has progressed despite treatment.
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I do not have severe liver problems or complications from liver disease.
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I have not had severe side effects from previous immunotherapy.
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I haven't had a serious wound, ulcer, or bone fracture in the last 28 days.
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My liver enzymes are within the normal range.
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I haven't had chemotherapy, immunotherapy, or experimental drugs in the last 3 weeks.
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I have not had severe gastrointestinal bleeding in the last 3 months.
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I do not have symptoms of active tuberculosis.
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My blood pressure has been under control with medication for over 4 weeks.
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I haven't needed treatment for an autoimmune disease in the last 2 years.
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I have never needed steroids for lung inflammation not caused by an infection.
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I haven't had a heart attack or stroke in the last 6 months.
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I do not have severe heart disease, recent heart attacks, or uncontrolled heart rhythm problems.
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I do not have acute hepatitis or any active infections.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I have not had major surgery in the last 28 days or a device placed under my skin in the last 7 days.
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I haven't coughed up a significant amount of blood recently and my cancer hasn't invaded major blood vessels.
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I've had one round of specific immune therapy for over 84 days.
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My kidney function, measured by creatinine levels or clearance, is within normal limits.
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I am not planning to receive any other cancer treatments while on this study.
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I haven't had radiotherapy in the last 14 days or lung radiation over 30 Gy in the past 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to a maximum of 3 years or death
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to a maximum of 3 years or death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Investigator Assessed-progression-free Survival (IA-PFS)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (ramucirumab, pembrolizumab)Experimental Treatment2 Interventions
Patients receive ramucirumab IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)Active Control6 Interventions
Patients receive docetaxel IV over 10-30 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 or ramucirumab IV over 60 minutes and docetaxel IV over 10-30 minutes on day 1. Patients with non-squamous NSCLC receiving docetaxel and gemcitabine hydrochloride, also receive pemetrexed IV over 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lexatumumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,004 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,645 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,205 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03971474 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm B (ramucirumab, pembrolizumab), Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03971474 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03971474 — Phase 2

Frequently Asked Questions

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

What are some of the potential side effects associated with Ramucirumab?

"Because there is only some data supporting its safety, Ramucirumab was given a score of 2."

Answered by AI

Are there any current vacancies for this research program?

"No, this particular trial is not currently looking for new participants. Although the listing on clinicaltrials.gov says it was most recently updated on October 8th, 2021, recruitment for this study actually ended long ago on May 28th, 2019. There are however other 4,860 studies that patients can take part in."

Answered by AI

How many individuals are enrolled in this clinical trial?

"This research is no longer enrolling patients. The study was first advertised on May 28th, 2019 and received its last update on October 8th, 2021. If you are interested in other studies, there are 2998 clinical trials actively recruiting for patients with non-small cell lung carcinoma and 1862 studies for Ramucirumab that still need participants."

Answered by AI

Could you direct me to other scientific research on Ramucirumab's efficacy?

"As of right now, there are 1862 different ongoing studies that include Ramucirumab with 410 trials in the third stage. Many clinical trials for Ramucirumab take place in Shanghai, but there are 78280 locations researching this medication."

Answered by AI

For what medical conditions is Ramucirumab commonly given to patients?

"Ramucirumab is most often used to treat malignant neoplasms, however it can also be effective for treating microsatellite instability high, non-small cell lung carcinoma, and unresectable melanoma."

Answered by AI

Are there different research facilities conducting this trial in North America?

"One hundred sites are running this clinical trial presently. They are situated in Goshen, Sioux Falls and Richmond among other cities. If you choose to participate in the trial, it would be beneficial to select a site closest to your location to reduce travel time commitments."

Answered by AI

Who else is applying?

What site did they apply to?
Novant Health Oncology Specialists-Wilkesboro
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)
2019. "Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03971474.
All > Vermont
~28 spots leftby May 2025
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