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



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:May 6, 2015
End Date:September 1, 2022

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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

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.


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.
We found this trial at
10
sites
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Moses Raj
Phone: 412-359-6220
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Bend, Oregon 97701
Principal Investigator: Robert Boone
Phone: 541-706-5800
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Bend, OR
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Charlotte, North Carolina 28204
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Charlotte, NC
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Denver, Colorado 80203
Principal Investigator: SMO Pharmatech Oncology Inc
Phone: 720-917-8400
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Edmonton, Alberta
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Fresh Meadows, New York 11365
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Jared Acoba
Phone: 808-545-8777
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Edward Garon
Phone: 310-267-8516
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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Los Angeles, California 90024
Principal Investigator: SMO TRIO -Translational Research
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Principal Investigator: Shaker Dakhil
Phone: 316-262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Wichita, KS
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