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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02411448
Recruitment Status : Active, not recruiting
First Posted : April 8, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE April 8, 2015
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE May 6, 2015
Actual Primary Completion Date January 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 37 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 38 Months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • 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) ]
Change History Complete list of historical versions of study NCT02411448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • 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 37 Months) ]
  • Disease Control Rate (DCR) [ Time Frame: Randomization to Disease Progression (Estimated as 37 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 37 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 38 Months) ]
  • Change from Baseline on the Lung Cancer Symptom Scale (LCSS) [ Time Frame: Baseline, End of Study (Estimated as 37 Months) ]
  • Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, End of Study (Estimated as 37 Months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC
Official Title  ICMJE 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
Brief Summary

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 those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Ramucirumab
    Administered IV.
    Other Name: LY3009806
  • Drug: Placebo
    Administered IV.
  • Drug: Erlotinib
    Administered orally.
  • Drug: Gefitinib
    Administered orally.
  • Drug: Osimertinib
    Administered orally.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Ramucirumab
    • Drug: Erlotinib
  • 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.

    Interventions:
    • Drug: Placebo
    • Drug: Erlotinib
  • Experimental: (Part C) Ramucirumab + Gefitinib or Osimertinib

    (Period 1) Ramucirumab given IV and gefitinib given orally.

    (Period 2) Ramucirumab given IV and osimertinib given orally.

    Interventions:
    • Drug: Ramucirumab
    • Drug: Gefitinib
    • Drug: Osimertinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2018)
543
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2015)
462
Estimated Study Completion Date  ICMJE September 1, 2022
Actual Primary Completion Date January 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 [exon 19 deletion or exon 21 (L858R) substitution mutation].
  • Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C).
  • At least one measurable lesion.
  • Life expectancy of at least 3 months.

Exclusion Criteria:

  • Known T790M EGFR mutation (not applicable for Part C Period 2).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Greece,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Romania,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02411448
Other Study ID Numbers  ICMJE 15540
I4T-MC-JVCY ( Other Identifier: Eli Lilly and Company )
2014-004824-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date February 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP