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
Email
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
Email

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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Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?