Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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25 March 2024 |
Main ID: |
NCT02411448 |
Date of registration:
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03/04/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
RELAY |
Scientific title:
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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 |
Date of first enrolment:
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May 6, 2015 |
Target sample size:
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545 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT02411448 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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France
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Germany
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Greece
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Hong Kong
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Italy
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Japan
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Korea, Republic of
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Romania
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Spain
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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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) |
Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metastatic Non-Small Cell Lung Cancer
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Intervention(s)
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Drug: Placebo
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Drug: Ramucirumab
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Drug: Osimertinib
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Drug: Erlotinib
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Drug: Gefitinib
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Primary Outcome(s)
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Part B: Progression Free Survival (PFS)
[Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)]
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Number of Participants With Treatment-Emergent Adverse Events
[Time Frame: Cycle 1 Day 1 through End of Study (Up To 3 Years)]
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Secondary Outcome(s)
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Part B: 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 (Up To 37 Months)]
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Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
[Time Frame: Baseline, Cycle 10 (each cycle is 2 weeks)]
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Part B: Number of Participants With Anti-Ramucirumab Antibodies
[Time Frame: Cycle 1 Predose through Follow-up (Up To 37 Months)]
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Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
[Time Frame: Baseline, Cycle 40 (each cycle is 2 weeks)]
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Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
[Time Frame: Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1]
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Part B: Overall Survival (OS)
[Time Frame: Randomization to Date of Death from Any Cause (Up To 37 Months)]
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Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
[Time Frame: Randomization to Progressive Disease (Up To 37 Months)]
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Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
[Time Frame: Baseline, End of Study (Up To 37 Months)]
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Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
[Time Frame: Baseline, Cycle 28 (each cycle is 2 weeks)]
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Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
[Time Frame: Randomization to Progressive Disease (Up To 37 Months)]
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Secondary ID(s)
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15540
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2014-004824-22
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I4T-MC-JVCY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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