Active not recruiting
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC
I4T-MC-JVCY - ClinicalTrials.gov - NCT02411448
The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B). The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.
How long will I be in the trial?
You can participate in this study for as long as your study doctor determines is appropriate
Active not recruiting
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC
I4T-MC-JVCY - ClinicalTrials.gov - NCT02411448
The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B). The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.
How long will I be in the trial?
You can participate in this study for as long as your study doctor determines is appropriate
Key Requirements
Age :
18+
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18+
Sex
All
Participants must
Participant must have diagnosis of Stage IV NSCLC
Participant must have documented evidence of a tumor with an activating EGFR mutation and be eligible for first-line treatment with erlotinib
Participant must be able to provide adequate archived Stage IV NSCLC tissue sample or tissue samples other than Stage IV NSCLC may be acceptable (optional for part C)
Participant must have ECOG performance status of 0 or 1 where 0 = Fully active, able to carry on all pre-disease performance without restriction and 1 = Restricted in physically strenuous activity but able to walk and carry out light work, e.g., light house work, office work
Participant must have one measurable lesion
Participants must NOT
Participant must not have a known T790M mutation
Participant must not have brain metastases
Participant must not have a history of significant bleeding disorders or blood clots in the arteries
Participant must not have any known significant abnormalities of the surface of the eye
Trial Summary
Conditions the trial is for
Non-small Cell Lung Cancer
What the trial is testing?
Ramucirumab, Placebo, Erlotinib, Gefitinib, Osimertinib
Could I receive a Placebo?
yes
Enrollment Goal
562
Trial Dates
May 2015 - February 2024
Trial Phase
3
Enter your postal code to find the nearest site
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18+
Sex
All
Participants must
Participant must have diagnosis of Stage IV NSCLC
Participant must have documented evidence of a tumor with an activating EGFR mutation and be eligible for first-line treatment with erlotinib
Participant must be able to provide adequate archived Stage IV NSCLC tissue sample or tissue samples other than Stage IV NSCLC may be acceptable (optional for part C)
Participant must have ECOG performance status of 0 or 1 where 0 = Fully active, able to carry on all pre-disease performance without restriction and 1 = Restricted in physically strenuous activity but able to walk and carry out light work, e.g., light house work, office work
Participant must have one measurable lesion
Participants must NOT
Participant must not have a known T790M mutation
Participant must not have brain metastases
Participant must not have a history of significant bleeding disorders or blood clots in the arteries
Participant must not have any known significant abnormalities of the surface of the eye
Trial Summary
Conditions the trial is for
Non-small Cell Lung Cancer
What the trial is testing?
Ramucirumab, Placebo, Erlotinib, Gefitinib, Osimertinib
Could I receive a Placebo?
yes
Enrollment Goal
562
Trial Dates
May 2015 - February 2024
Trial Phase
3
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Trial Locations
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