History of Changes for Study: NCT02411448

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

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Study Record Versions

Version	Submitted Date	Changes
1	April 3, 2015	None (earliest Version on record)
2	April 9, 2015	Study Status and Study Identification
3	April 29, 2015	Contacts/Locations and Study Status
4	May 21, 2015	Recruitment Status, Study Status, Contacts/Locations and Oversight
5	June 24, 2015	Contacts/Locations and Study Status
6	July 21, 2015	Contacts/Locations and Study Status
7	August 24, 2015	Study Status and Contacts/Locations
8	September 1, 2015	Contacts/Locations and Study Status
9	September 8, 2015	Contacts/Locations and Study Status
10	September 21, 2015	Contacts/Locations and Study Status
11	September 23, 2015	Contacts/Locations and Study Status
12	October 20, 2015	Contacts/Locations and Study Status
13	November 4, 2015	Study Status and Contacts/Locations
14	November 18, 2015	Contacts/Locations and Study Status
15	December 7, 2015	Contacts/Locations and Study Status
16	December 21, 2015	Contacts/Locations and Study Status
17	January 8, 2016	Contacts/Locations and Study Status
18	January 28, 2016	Contacts/Locations and Study Status
19	February 19, 2016	Study Status and Contacts/Locations
20	March 9, 2016	Contacts/Locations and Study Status
21	April 6, 2016	Contacts/Locations and Study Status
22	May 6, 2016	Contacts/Locations and Study Status
23	May 24, 2016	Contacts/Locations and Study Status
24	June 14, 2016	Contacts/Locations and Study Status
25	July 7, 2016	Study Status and Contacts/Locations
26	July 12, 2016	Contacts/Locations and Study Status
27	July 27, 2016	Contacts/Locations and Study Status
28	August 29, 2016	Study Status and Contacts/Locations
29	September 22, 2016	Study Status and Contacts/Locations
30	October 6, 2016	Study Status and Contacts/Locations
31	October 21, 2016	Contacts/Locations and Study Status
32	December 5, 2016	Study Status and Contacts/Locations
33	December 16, 2016	Contacts/Locations and Study Status
34	January 7, 2017	Contacts/Locations and Study Status
35	January 19, 2017	Contacts/Locations and Study Status
36	February 1, 2017	Study Status and Contacts/Locations
37	March 6, 2017	Contacts/Locations and Study Status
38	March 22, 2017	Contacts/Locations and Study Status
39	April 4, 2017	Study Status and Contacts/Locations
40	April 19, 2017	Contacts/Locations, Eligibility and Study Status
41	May 5, 2017	Contacts/Locations and Study Status
42	May 8, 2017	Contacts/Locations and Study Status
43	June 12, 2017	Study Status and Contacts/Locations
44	June 13, 2017	Contacts/Locations and Study Status
45	June 25, 2017	Contacts/Locations and Study Status
46	July 5, 2017	Contacts/Locations and Study Status
47	July 17, 2017	Contacts/Locations and Study Status
48	July 28, 2017	Contacts/Locations and Study Status
49	August 15, 2017	Study Status and Contacts/Locations
50	September 2, 2017	Contacts/Locations and Study Status
51	September 20, 2017	Contacts/Locations and Study Status
52	October 3, 2017	Contacts/Locations and Study Status
53	November 3, 2017	Contacts/Locations and Study Status
54	December 23, 2017	Contacts/Locations and Study Status
55	January 5, 2018	Contacts/Locations and Study Status
56	January 26, 2018	Contacts/Locations and Study Status
57	February 2, 2018	Contacts/Locations and Study Status
58	February 14, 2018	Contacts/Locations and Study Status
59	February 23, 2018	Contacts/Locations and Study Status
60	March 19, 2018	Contacts/Locations and Study Status
61	March 27, 2018	Contacts/Locations and Study Status
62	April 5, 2018	Contacts/Locations and Study Status
63	June 4, 2018	Arms and Interventions, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Design and Study Description
64	August 1, 2018	Contacts/Locations and Study Status
65	August 23, 2018	Contacts/Locations and Study Status
66	August 30, 2018	Contacts/Locations and Study Status
67	September 21, 2018	Contacts/Locations and Study Status
68	October 1, 2018	Contacts/Locations and Study Status
69	October 26, 2018	Recruitment Status, Contacts/Locations and Study Status
70	November 19, 2018	Study Status
71	December 3, 2018	Study Status
72	February 12, 2019	Study Status
73	October 17, 2019	Arms and Interventions, Study Status, Study Design, IPDSharing, Study Description and Study Identification
	Results Submission Events
January 17, 2020 February 17, 2020		Returned after QC review: January 29, 2020 (Canceled on February 18, 2020)
74	February 18, 2020	Outcome Measures, Study Status, Document Section, Results, Arms and Interventions, Study Description and Study Identification
75	March 15, 2020	Study Status
76	April 21, 2020	Study Status
77	May 4, 2020	Study Status
78	May 18, 2020	Study Status
79	June 8, 2020	Study Status and References
80	July 2, 2020	Study Status
81	July 16, 2020	Study Status
82	August 4, 2020	Study Status
83	August 18, 2020	Study Status
84	September 4, 2020	Study Status
85	September 17, 2020	Study Status
86	October 6, 2020	Study Status
87	October 16, 2020	Study Status
88	November 4, 2020	Study Status
89	March 17, 2021	Study Status
90	April 18, 2022	Study Status and References
91	May 31, 2023	Study Status
92	March 15, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	15540
Brief Title:	A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC
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
Secondary IDs:	I4T-MC-JVCY [Eli Lilly and Company] 2014-004824-22 [EudraCT Number]

Study Status


Record Verification:	April 2015
Overall Status:	Not yet recruiting
Study Start:	May 2015
Primary Completion:	August 2018 [Anticipated]
Study Completion:	April 2020 [Anticipated]

First Submitted:	April 3, 2015
First Submitted that Met QC Criteria:	April 3, 2015
First Posted:	April 8, 2015 [Estimate]

Last Update Submitted that Met QC Criteria:	April 3, 2015
Last Update Posted:	April 8, 2015 [Estimate]

Sponsor/Collaborators


Sponsor:	Eli Lilly and Company
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

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).

Detailed Description:

Conditions


Conditions:	Metastatic Non-Small Cell Lung Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	462 [Anticipated]

Arms and Interventions

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 Names:

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

Outcome Measures


Primary Outcome Measures:
1.	Progression Free Survival (PFS) [ Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 33 Months) ]
2.	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:
1.	Overall Survival (OS) [ Time Frame: Randomization to Date of Death from Any Cause (Estimated as 47 Months) ]
2.	Objective Response Rate (ORR) [ Time Frame: Randomization to Disease Progression (Estimated as 33 Months) ]
3.	Disease Control Rate (DCR) [ Time Frame: Randomization to Disease Progression (Estimated as 33 Months) ]
4.	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) ]
5.	Pharmacokinetics (PK): Minimum Concentration (CMIN) of Ramucirumab [ Time Frame: Cycle 2 Predose through Cycle 14 Predose (Estimated as 28 Months) ]
6.	Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Cycle 1 Predose through Follow-up (Estimated as 34 Months) ]
7.	Change from Baseline on the Lung Cancer Symptom Scale (LCSS) [ Time Frame: Baseline, End of Study (Estimated as 33 Months) ]
8.	Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, End of Study (Estimated as 33 Months) ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
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 sample. 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/moderate 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/Locations


Central Contact Person:	There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or Telephone: 1-317-615-4559
Study Officials:	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) Study Director Eli Lilly and Company
Locations:	United States, California
	UCLA Medical Center Santa Monica, California, United States, 90404 Contact:Contact: 310-633-8400 Contact:Principal Investigator: Eddie Garon
	United States, Hawaii
	The Queen's Medical Center Honolulu, Hawaii, United States, 96813 Contact:Contact: 808-545-8777 Contact:Principal Investigator: J D Acoba
	United States, Massachusetts
	University of Massachusetts Medical Center Worcester, Massachusetts, United States, 01606 Contact:Contact: 978-343-5048 Contact:Principal Investigator: F Gu
	United States, North Carolina
	Carolinas Medical Center Charlotte, North Carolina, United States, 28204 Contact:Contact: 704-355-2884 Contact:Principal Investigator: Kathryn Mileham
	United States, Oregon
	Portland VA Medical Center Portland, Oregon, United States, 97213 Contact:Contact: 503-215-5696 Contact:Principal Investigator: Rachel Sanborn
	France
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bron, France, 69677 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Grenoble, France, 38049 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lille, France Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Montpellier, France, 34295 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Paris, France, 75015 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Poitiers, France, 86021 Contact:Contact: Eli Lilly and Company
	Germany
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Berlin, Germany, 14165 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gerlingen, Germany, 70839 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Großhansdorf, Germany, 22927 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heidelberg, Germany, 69126 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Köln, Germany, 51109 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ulm, Germany, 89081 Contact:Contact: Eli Lilly and Company
	Hong Kong
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hong Kong, Hong Kong Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kowloon, Hong Kong Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lai Chi Kok, Hong Kong Contact:Contact: Eli Lilly and Company
	Italy
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bologna, Italy, 40138 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Milano, Italy, 20132 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Padova, Italy, 35128 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pordenone, Italy, 33170 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Torino, Italy, 10043 Contact:Contact: Eli Lilly and Company
	Japan
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chiba, Japan, 277 8577 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fukuoka, Japan, 811-1395 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Okayama, Japan, 700-8558 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Osaka, Japan, 589-8511 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shizuoka, Japan, 411-8777 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tokyo, Japan, 104-0045 Contact:Contact: Eli Lilly and Company
	Korea, Republic of
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Incheon, Korea, Republic of, 405-760 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seongnam-Si, Korea, Republic of, 463-707 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seoul, Korea, Republic of, 135-710 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seowon-gu, Korea, Republic of, 361-711 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Suwon, Korea, Republic of, 443-721 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ulsan-si, Korea, Republic of, 682-714 Contact:Contact: Eli Lilly and Company
	Spain
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barcelona, Spain, 08907 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madrid, Spain, 28041 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sevilla, Spain, 41013 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valencia, Spain, 46026 Contact:Contact: Eli Lilly and Company
	Taiwan
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kaohsiung, Taiwan, 83301 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taichung, Taiwan, 404 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tainan, Taiwan, 70403 Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taipei, Taiwan, 112 Contact:Contact: Eli Lilly and Company
	United Kingdom
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. London, United Kingdom, SW3 6JJ Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nottingham, United Kingdom, NG5 1PB Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Preston, United Kingdom, PR2 9HT Contact:Contact: Eli Lilly and Company
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wolverhampton, United Kingdom, WV10 0QP Contact:Contact: Eli Lilly and Company

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: