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Monoclonal Antibodies

Ramucirumab + Pembrolizumab for 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

No Placebo-Only Group

Approved for 10 Other Conditions

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to a maximum of 3 years or death

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

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

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DOR)

Investigator Assessed-progression-free Survival (IA-PFS)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

0 / 22Eligibility criteria met