Your session is about to expire
← Back to Search
Monoclonal Antibodies
Ramucirumab + Atezolizumab for Lung Cancer (RamAtezo-1 Trial)
Phase 2
Waitlist Available
Led By Daniel Morgensztern, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed squamous or non-squamous non-small cell lung cancer
Patients with known EGFR or ALK mutations are eligible only if they have received at least one line of targeted therapy for these mutations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 weeks
Awards & highlights
RamAtezo-1 Trial Summary
This trial will test whether combining two drugs, ramucirumab and atezolizumab, is more effective than traditional therapy in treating non-small cell lung cancer in patients who have previously received immune checkpoint blockers.
Who is the study for?
Adults with advanced-stage non-small cell lung cancer (NSCLC) who have previously been treated with immune checkpoint blockers. They must have a biopsy available, normal organ and bone marrow function, no severe infections or recent thromboembolic events, not be on certain medications, and agree to use contraception. Excluded are those with uncontrolled hypertension, significant liver disease, known allergies to study drugs, autoimmune diseases, untreated brain metastases among other conditions.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining ramucirumab and atezolizumab in NSCLC patients who didn't respond well to previous immune therapies. It's a pilot study where participants will receive both drugs and undergo regular monitoring through blood tests and biopsies.See study design
What are the potential side effects?
Potential side effects include high blood pressure from ramucirumab; allergic reactions; fatigue; liver issues; bleeding problems; protein in urine indicating possible kidney issues. Atezolizumab can cause similar side effects plus potential inflammation of organs.
RamAtezo-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed by lab tests to be non-small cell type.
Select...
I have EGFR or ALK mutations and have undergone at least one targeted therapy.
Select...
My cancer can be measured by scans or physical exam.
Select...
I have previously been treated with drugs that boost the immune system.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
RamAtezo-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 weeks
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 (ORR)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Overall Survival (OS)
Progression-free Survival (PFS)
+1 moreSide 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%
Dyspepsia
6%
Dehydration
6%
Pain
6%
Haemoptysis
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Metastatic pain
1%
Hyponatraemia
1%
Chronic obstructive pulmonary disease
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
RamAtezo-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: Ramucirumab + AtezolizumabExperimental Treatment4 Interventions
Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg.
Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Ramucirumab
2017
Completed Phase 3
~5050
Peripheral blood draw
2017
Completed Phase 2
~60
Biopsy
2014
Completed Phase 4
~850
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,688 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,613 Previous Clinical Trials
3,200,908 Total Patients Enrolled
Daniel Morgensztern, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to drugs that are similar to the ones being used in the study.I haven't taken strong immune system medications in the last 2 weeks.I have a history of lung scarring or inflammation not caused by infections.I have not coughed up a significant amount of blood recently nor does my cancer invade major blood vessels.I haven't had any serious wounds, ulcers, or bone fractures in the last 28 days.I have active tuberculosis.I have not received a live flu vaccine within the last 4 weeks.I haven't had severe infections or needed antibiotics in the last 2 weeks.I have had a serious blood clot in the last 3 months.I am 18 years old or older.My high blood pressure has not been controlled for over 4 weeks despite treatment.I haven't had any cancer, except for certain low-risk types, in the last 3 years.My brain metastases are stable, and I haven't needed steroids or had recent brain treatments.I haven't had a heart attack, stroke, or similar event in the last 6 months.I have not had severe bleeding in my stomach or intestines in the last 3 months.I haven't had a GI perforation or fistula, or risk factors for one, in the last 6 months.I have not had major surgery in the last 28 days or minor surgery in the last 7 days.I do not have significant liver disease or active hepatitis B or C.My lung cancer is confirmed by lab tests to be non-small cell type.I have EGFR or ALK mutations and have undergone at least one targeted therapy.My cancer can be measured by scans or physical exam.I have previously been treated with drugs that boost the immune system.I have an autoimmune disease but it's either stable or controlled.I can provide previous biopsy samples or am willing to have a new biopsy for the study.I am fully active or can carry out light work.I am on a daily aspirin or similar blood-thinning medication, but no more than 325 mg/day.I am HIV-positive.You have normal blood and organ function, and you are not pregnant or at risk of becoming pregnant during the study. You also need to understand and agree to the study's rules.
Research Study Groups:
This trial has the following groups:- Group 1: Ramucirumab + Atezolizumab
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.
Is this medical experiment the inaugural of its kind?
"Hoffmann-La Roche's Ramucirumab has been trialled in 397 studies, spread across 74 countries and 1771 cities. The inaugural test of this drug was conducted back in 2008, involving 720 patients; it successfully passed its Phase 2 clinical trial phase. Since then, a further 185 trials have been completed."
Answered by AI
In what contexts is Ramucirumab typically employed?
"Ramucirumab is traditionally administered to treat small cell lung cancer (SCLC), but can also be used in instances of non-small cell lung carcinoma, malignancy, and postoperative healing."
Answered by AI
Has Ramucirumab been the subject of any other investigations?
"Presently, 397 clinical trials for Ramucirumab are in progress with 78 of those studies on Phase 3. The majority are located in Pittsburgh, Pennsylvania; however, 21761 sites across the country offer this medication as part of a medical trial."
Answered by AI
What adverse effects has Ramucirumab been associated with?
"Ramucirumab was assessed to have a safety rating of 2 on the 1-3 scale due to its standing in Phase 2, with some data pertaining to safety but none for efficacy."
Answered by AI
Are there any open vacancies for participation in this research project?
"Information published on clinicaltrials.gov states that this study is not currently enrolling participants; the initial posting was June 5th 2019 and it has most recently been updated August 10th 2022. Although, there are over two thousand other studies actively seeking volunteers at present."
Answered by AI
What is the scope of enrollment for this research endeavor?
"Unfortunately, this trial is no longer enrolling. It was first posted on June 5th 2019 and last updated August 10th 2022. For those seeking other trials to participate in, there are 2082 studies with carcinoma non-small cell lung actively recruiting and 397 involving Ramucirumab that are open for enrollment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger