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Ramucirumab + Erlotinib for Lung Cancer (RELAY Trial)
RELAY Trial Summary
This trial is evaluating the efficacy and safety of ramucirumab in combination with erlotinib or gefitinib as compared to placebo in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation.
RELAY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 1253 Patients • NCT01168973RELAY Trial Design
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- You are expected to live for at least 3 more months.You are able to receive erlotinib as your first treatment if your tumor has certain mutations in the EGFR gene.You need to provide tissue samples from your lung cancer. If you don't have stage IV lung cancer, other tissue samples may be accepted.You have been diagnosed with Stage IV non-small cell lung cancer according to specific guidelines from 2009.You have at least one spot that can be measured to see how the treatment is working.You have been diagnosed with Stage IV non-small cell lung cancer according to specific medical guidelines.You have at least one visible and measurable area of concern for the study.You have been taking nonsteroidal anti-inflammatory drugs for more than 2 months.You are expected to live for at least 3 more months.You have a history of coughing up a lot of blood.There are visible holes inside the tumor on the imaging tests.You have a specific T790M mutation in your EGFR gene.You have cancer spread to the covering of the brain or the spinal cord, or uncontrolled spinal cord pressure.You are currently taking certain medications that affect how other drugs work in your body.You have any important eye surface problems.You can receive erlotinib as your first treatment if your tumor has specific genetic mutations.The cancer has spread to major blood vessels.You must provide tissue samples from your lung cancer, or other tissue samples may be acceptable.You have a history of bowel blockage or extensive surgery on your intestines.You had a blood clot in an artery within the last 6 months before joining the study.You had a hole in your stomach or intestines in the last 6 months.You have a serious bleeding problem.
- Group 1: Ramucirumab + Gefitinib or Osimertinib
- Group 2: Ramucirumab + Erlotinib
- Group 3: Placebo + Erlotinib
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
For what medical condition is Ramucirumab most often prescribed as a treatment?
"Ramucirumab is an effective medical intervention for patients suffering from malignant neoplasms, adenocarcinoma, and disease progression after chemotherapy."
Why was this research project undertaken?
"The purpose of this study is to assess the effect of lenalidomide on overall survival in patients with progressive disease or death from any cause. Secondary outcomes include Part B: Best Change From Baseline on the Lung cancer Symptom Scale (LCSS) and Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score. The goal is toNumber of Participants With Treatment-Emergent Adverse Events and Overall Survival (OS)."
Are we still able to enroll people in this experiment?
"Unfortunately, this study is no longer recruiting patients as of April 18th, 2022. This is according to the clinicaltrials.gov listing, which also reports that the trial was originally posted on May 6th, 2015. However, there are over 2000 other trials that are still accepting patients."
How many people are included in this clinical trial at most?
"Currently, this particular study is not recruiting any more patients. It was initially posted on May 6th, 2015 but the most recent edit occurred on April 18th, 2022. However, there are 1,961 other clinical trials for lung cancer and 222 for Ramucirumab that are still looking for participants."
Does Ramucirumab have FDA approval for therapeutic use?
"Ramucirumab has been through multiple rounds of testing and there is some data supporting its efficacy, so it received a score of 3."
Could you please tell us what other research has been conducted utilizing Ramucirumab?
"Ramucirumab was first studied 18 years ago at Mayo Clinic in Rochester. Including the original research, a total of 18875 studies have been completed. At the moment, there are 222 clinical trials actively recruiting participants, many of which are based in Edmonton, Alberta."
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