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Monoclonal Antibodies
Ramucirumab + Pembrolizumab for Lung Cancer
Phase 2
Waitlist Available
Led By Erin M Bertino, M.D.
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to see if they're more effective than one of the drugs alone in treating lung cancer that has come back or spread.
Who is the study for?
Adults aged ≥18 with recurrent or metastatic non-small cell lung cancer harboring EGFR mutations can join this trial. They must have adequate organ function, no prior PD/PD-L1 inhibitor treatment, and be willing to use effective contraception if of childbearing potential. Excluded are those with recent live vaccines, pneumonitis history, uncontrolled hypertension, significant thromboembolic events within the past 3 months, active infections requiring systemic therapy, or known hypersensitivity to study drugs.Check my eligibility
What is being tested?
The trial is testing a combination of ramucirumab and pembrolizumab for treating EGFR mutant non-small cell lung cancer that has returned or spread. Ramucirumab may block tumor growth by cutting off blood supply while pembrolizumab might boost the immune system's response against cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site; high blood pressure; bleeding issues; increased risk of infection due to immune system suppression; possible liver problems indicated by abnormal tests; fatigue and weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Clinical benefit rate (complete response + partial response + stable disease)
Incidence of adverse events
Overall survival
+1 moreOther outcome measures
Change in circulating VEGF levels
Circulating immune cell profiles in response to treatment and in relation to clinical response
Tumor immunoprofile
Side effects data
From 2016 Phase 3 trial • 1253 Patients • NCT0116897346%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Peripheral sensory neuropathy
12%
Back pain
11%
Dysgeusia
11%
Hypertension
11%
Insomnia
11%
Headache
11%
Arthralgia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Dizziness
7%
Nail discolouration
6%
Dehydration
6%
Pain
6%
Dyspepsia
6%
Haemoptysis
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Lobar pneumonia
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ramucirumab, pembrolizumab)Experimental Treatment2 Interventions
Patients receive ramucirumab IV over 60 minutes and 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Ramucirumab
2017
Completed Phase 3
~5050
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,161 Total Patients Enrolled
Erin M Bertino, M.D.Principal InvestigatorOhio State University Comprehensive Cancer Center
Asrar Alahmadi, MBBS, MAS-CRPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a live vaccine within the last 30 days before starting the study. This includes vaccines for diseases like measles, mumps, rubella, and chicken pox. You can still participate if you got a flu shot that was injected, but not if you got the nasal spray flu vaccine.You have had a lung condition called pneumonitis that needed steroids, or you currently have pneumonitis.You have had a hole or abnormal connection in your digestive system in the last 6 months, or you are at risk for this kind of problem.You have small cell or mixed (small cell/non-small cell) lung cancer.You have been treated with certain types of immunotherapy drugs before.You have had active tuberculosis in the past.Your organs and blood must work properly according to the study's guidelines.Your high blood pressure is not well managed with medication.You have severe liver cirrhosis or complications from cirrhosis, like hepatic encephalopathy or significant fluid buildup in the abdomen.You have had a serious blood clot in the past 3 months. This includes deep vein thrombosis, pulmonary embolism, or other major blood clots.You had severe bleeding in your digestive system within the last 3 months before starting the study treatment.You have a current infection that needs treatment with medication throughout your body.You have a disease that can be measured using specific criteria.You are able to perform everyday activities without any problem, or with a little restriction.You can have had treatment for cancer before, but not with certain specific drugs. If you took these drugs, you need to wait for a certain amount of time before joining the trial.You have an autoimmune disease that has needed strong medicine in the past 2 years to manage it.You are taking certain medications like dipyridamole or clopidogrel, but you can still participate if you are taking a low dose of aspirin once a day.You have coughed up a noticeable amount of bright red blood within 2 months before starting the treatment, or the cancer has grown into major blood vessels.You had a heart attack, stroke, or other serious heart-related event in the last 6 months.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.You must be 18 years or older.You have a specific type of lung cancer that has come back or spread, and you have certain genetic mutations in the cancer cells.You have a serious wound, ulcer, or bone fracture that has not healed within the last 28 days.You have HIV/AIDS, active Hepatitis B, or active Hepatitis C. If you have a history of Hepatitis B or C, you are also excluded.You have taken ramucirumab before.You have untreated brain metastases, or you have been treated for brain metastases but have not been stable for a certain period of time.If you are a woman who can have children, you need to have a negative pregnancy test within 3 days before starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ramucirumab, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the official status of Ramucirumab in America?
"Ramucirumab's safety is only supported by Phase 2 trial data, so it received a score of 2."
Answered by AI
What are some of the primary conditions that Ramucirumab is used to treat?
"Ramucirumab is indicated for the treatment of patients with unresectable malignant neoplasms, microsatellite instability high, and unresectable melanoma."
Answered by AI
Are researchers currently looking for new participants in this trial?
"This clinical trial, which was posted on June 17th 2020 and last updated on October 28th 2022, is currently seeking participants according to the information available on clinicaltrials.gov."
Answered by AI
What are some previous examples of research done with Ramucirumab?
"At present, there are 1039 on-going clinical trials for Ramucirumab with 129 of them being Phase 3 research. While a large quantity of the work is based in Rochester, Minnesota; 38292 locations worldwide are conducting studies involving Ramucirumab."
Answered by AI
How many test subjects are currently a part of this experiment?
"That is accurate. The details available on clinicaltrials.gov show that this research is actively seeking volunteers. This particular trial was first publicized on June 17th, 2020 with the most recent update being October 28th, 2022. Currently, 51 individuals are needed at a single location."
Answered by AI
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