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A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

This study is currently recruiting participants.
Verified November 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02411448
First Posted: April 8, 2015
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
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).

Condition Intervention Phase
Metastatic Non-Small Cell Lung Cancer Drug: Ramucirumab Drug: Placebo Drug: Erlotinib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 33 Months) ]
  • Number of Participants with One or More Drug Related Adverse Events (AEs) or Any Serious AEs [ Time Frame: Cycle 1 Day 1 through End of Study (Estimated as 34 Months) ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization to Date of Death from Any Cause (Estimated as 47 Months) ]
  • Objective Response Rate (ORR) [ Time Frame: Randomization to Disease Progression (Estimated as 33 Months) ]
  • Disease Control Rate (DCR) [ Time Frame: Randomization to Disease Progression (Estimated as 33 Months) ]
  • Duration of Response (DoR) [ Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated as 33 Months) ]
  • Pharmacokinetics (PK): Minimum Concentration (CMIN) of Ramucirumab [ Time Frame: Cycle 2 Predose through Cycle 14 Predose (Estimated as 28 Months) ]
  • Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Cycle 1 Predose through Follow-up (Estimated as 34 Months) ]
  • Change from Baseline on the Lung Cancer Symptom Scale (LCSS) [ Time Frame: Baseline, End of Study (Estimated as 33 Months) ]
  • Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, End of Study (Estimated as 33 Months) ]

Estimated Enrollment: 462
Study Start Date: May 2015
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab + Erlotinib

(Part A) 10 milligrams per kilogram (mg/kg) ramucirumab every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

(Part B) 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally . Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Ramucirumab
Administered IV
Other Name: LY3009806
Drug: Erlotinib
Administered orally
Placebo Comparator: Placebo + Erlotinib

(Part A) Not Applicable

(Part B) Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Placebo
Administered IV
Drug: Erlotinib
Administered orally

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
  • Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R).
  • Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable.
  • At least one measurable lesion.
  • Life expectancy of at least 3 months.

Exclusion Criteria:

  • Known T790M EGFR mutation.
  • Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
  • Serious illness or medical condition.
  • Ongoing treatment with CYP3A4 inducers or strong inhibitors.
  • Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
  • History of gross hemoptysis.
  • Significant bleeding disorders.
  • Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
  • Radiographic evidence of intratumor cavitation.
  • History of gastrointestinal perforation within last 6 months.
  • History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
  • History of any arterial thrombotic event within 6 months prior to enrollment.
  • The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411448


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 119 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02411448     History of Changes
Other Study ID Numbers: 15540
I4T-MC-JVCY ( Other Identifier: Eli Lilly and Company )
2014-004824-22 ( EudraCT Number )
First Submitted: April 3, 2015
First Posted: April 8, 2015
Last Update Posted: November 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ramucirumab
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action