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A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ramucirumab

Placebo (for Ramucirumab)

Docetaxel

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring second line, non small cell lung cancer, NSCLC, phase 3, ramucirumab, lung cancer, docetaxel, taxotere

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy
Prior bevacizumab as first-line and/or maintenance therapy is allowed
Signed informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Histologically or cytologically confirmed NSCLC
Stage IV NSCLC disease
Participants have measurable or nonmeasurable disease
Adequate organ function, defined as:
- Total bilirubin less than or equal to Upper Limit of Normal (ULN),
- Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases,
- Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 50 milliliters per minute (ml/min) (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection),
- Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^3/microliters (µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dL), and platelets greater than or equal to 100 x 10^3/µL,
- Adequate coagulation function as defined by International Normalized Ratio (INR) less than or equal to 1.5, or prothrombin time and partial thromboplastin time less than or equal to 1.5 x ULN.
- The participant does not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
Urinary protein is less than or equal to 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria greater than or equal to 2+, a 24-hour urine must be collected and must demonstrate less than 1000 milligrams (mg) of protein.
Participants of reproductive potential (both sexes) must agree to use reliable method of birth control (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy
Life expectancy of greater than or equal to 3 months
Prior radiation therapy is allowed if: In the case of chest radiotherapy at least 28 days have elapsed from the completion of radiation treatment prior to randomization; In the case of focal or palliative radiation treatment at least 7 days have elapsed from last radiation treatment prior to randomization (and provided that 25% or less of total bone marrow had been irradiated); In the case of Central Nervous System (CNS) radiation at least 14 days have elapsed from the completion of radiation treatment prior to randomization

Exclusion Criteria:

Disease progression on more than 1 prior chemotherapy regimens
Participants whose only prior treatment was a tyrosine kinase inhibitor
The participant's tumor wholly or partially contains small cell lung cancer
Major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months.
Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy
Last dose of bevacizumab must be at least 28 days from time of randomization
Last dose of cytotoxic chemotherapy must be at least 14 days from time of randomization
The participant has untreated CNS metastases. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment Magnetic Resonance Imaging (MRI) or IV contrast Computed Tomography (CT) scan.
Radiologically documented evidence of major blood vessel invasion or encasement by cancer
Radiographic evidence of intratumor cavitation
History of uncontrolled hereditary or acquired thrombotic disorder
Chronic therapy with nonsteroidal anti-inflammatory drug (NSAIDs) or other antiplatelet agents; Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted
History of gross hemoptysis (defined as bright red blood or greater than or equal to 1/2 teaspoon) within 2 months prior to randomization
Clinically relevant congestive heart failure [New York Heart Association (NYHA II-IV)] or symptomatic or poorly controlled cardiac arrhythmia
Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization
Uncontrolled arterial hypertension greater than or equal to 150 / greater than or equal to 90 millimeters of mercury (mm Hg) despite standard medical management
Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
Significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding within 3 months prior to randomization
Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to randomization
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
Peripheral neuropathy greater than or equal to Grade 2 [National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.02]
Serious illness or medical condition(s) including, but not limited to: Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness; Active or uncontrolled clinically serious infection; Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Known allergy or hypersensitivity reaction to any of the treatment components
The participant is pregnant or breastfeeding
Current or recent (within 28 days prior to randomization) treatment with an investigational drug or device that has not received regulatory approval for any indication at the time of randomization, or participation in another interventional clinical trial
Prior therapy with docetaxel

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramucirumab + Docetaxel

Placebo + Docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.

Secondary Outcome Measures

Progression-Free Survival (PFS) Time

PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.

Percentage of Participants Achieving an Objective Response (Objective Response Rate)

Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.

Percentage of Participants Achieving Disease Control (Disease Control Rate)

Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)*100.

Maximum Improvement on Lung Cancer Symptom Scale (LCSS)

The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.

Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores

The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).

Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab

Number of Participants With Anti-Ramucirumab Antibodies

The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.

Full Information

NCT ID

NCT01168973

First Posted

July 16, 2010

Last Updated

September 10, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01168973

Brief Title

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

Official Title

A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

second line, non small cell lung cancer, NSCLC, phase 3, ramucirumab, lung cancer, docetaxel, taxotere

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1253 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ramucirumab + Docetaxel

Arm Type

Experimental

Arm Title

Placebo + Docetaxel

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Ramucirumab

Other Intervention Name(s)

IMC 1121B, LY3009806

Intervention Description

10 milligrams per kilogram (mg/kg) administered intravenously (IV) on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Intervention Type

Drug

Intervention Name(s)

Placebo (for Ramucirumab)

Intervention Description

Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only with protocol amendment dated 22 May 2012) administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time Frame

Randomization to date of death from any cause (up to 34 months)

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS) Time

Description

Time Frame

Randomization to measured PD or date of death from any cause (up to 29 months)

Title

Percentage of Participants Achieving an Objective Response (Objective Response Rate)

Description

Time Frame

Baseline to measured PD (up to 29 months)

Title

Percentage of Participants Achieving Disease Control (Disease Control Rate)

Description

Time Frame

Baseline to measured PD (up to 29 months)

Title

Maximum Improvement on Lung Cancer Symptom Scale (LCSS)

Description

Time Frame

Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Title

Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores

Description

Time Frame

Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Title

Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab

Time Frame

Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)

Title

Number of Participants With Anti-Ramucirumab Antibodies

Description

Time Frame

Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Other Pre-specified Outcome Measures:

Title

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died

Description

Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Time Frame

First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy Prior bevacizumab as first-line and/or maintenance therapy is allowed Signed informed consent Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Histologically or cytologically confirmed NSCLC Stage IV NSCLC disease Participants have measurable or nonmeasurable disease Adequate organ function, defined as: Total bilirubin less than or equal to Upper Limit of Normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases, Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 50 milliliters per minute (ml/min) (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection), Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^3/microliters (µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dL), and platelets greater than or equal to 100 x 10^3/µL, Adequate coagulation function as defined by International Normalized Ratio (INR) less than or equal to 1.5, or prothrombin time and partial thromboplastin time less than or equal to 1.5 x ULN. The participant does not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis. Urinary protein is less than or equal to 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria greater than or equal to 2+, a 24-hour urine must be collected and must demonstrate less than 1000 milligrams (mg) of protein. Participants of reproductive potential (both sexes) must agree to use reliable method of birth control (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy Life expectancy of greater than or equal to 3 months Prior radiation therapy is allowed if: In the case of chest radiotherapy at least 28 days have elapsed from the completion of radiation treatment prior to randomization; In the case of focal or palliative radiation treatment at least 7 days have elapsed from last radiation treatment prior to randomization (and provided that 25% or less of total bone marrow had been irradiated); In the case of Central Nervous System (CNS) radiation at least 14 days have elapsed from the completion of radiation treatment prior to randomization Exclusion Criteria: Disease progression on more than 1 prior chemotherapy regimens Participants whose only prior treatment was a tyrosine kinase inhibitor The participant's tumor wholly or partially contains small cell lung cancer Major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months. Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy Last dose of bevacizumab must be at least 28 days from time of randomization Last dose of cytotoxic chemotherapy must be at least 14 days from time of randomization The participant has untreated CNS metastases. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment Magnetic Resonance Imaging (MRI) or IV contrast Computed Tomography (CT) scan. Radiologically documented evidence of major blood vessel invasion or encasement by cancer Radiographic evidence of intratumor cavitation History of uncontrolled hereditary or acquired thrombotic disorder Chronic therapy with nonsteroidal anti-inflammatory drug (NSAIDs) or other antiplatelet agents; Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted History of gross hemoptysis (defined as bright red blood or greater than or equal to 1/2 teaspoon) within 2 months prior to randomization Clinically relevant congestive heart failure [New York Heart Association (NYHA II-IV)] or symptomatic or poorly controlled cardiac arrhythmia Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization Uncontrolled arterial hypertension greater than or equal to 150 / greater than or equal to 90 millimeters of mercury (mm Hg) despite standard medical management Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization Significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding within 3 months prior to randomization Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to randomization Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea Peripheral neuropathy greater than or equal to Grade 2 [National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.02] Serious illness or medical condition(s) including, but not limited to: Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness; Active or uncontrolled clinically serious infection; Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration Known allergy or hypersensitivity reaction to any of the treatment components The participant is pregnant or breastfeeding Current or recent (within 28 days prior to randomization) treatment with an investigational drug or device that has not received regulatory approval for any indication at the time of randomization, or participation in another interventional clinical trial Prior therapy with docetaxel

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

City

Sedona

State/Province

Arizona

ZIP/Postal Code

86336

Country

United States

Facility Name

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

City

Alhambra

State/Province

California

ZIP/Postal Code

91801

Country

United States

Facility Name

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

City

Santa Monica

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30901

Country

United States

Facility Name

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30045

Country

United States

Facility Name

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

City

Rome

State/Province

Georgia

ZIP/Postal Code

30165

Country

United States

Facility Name

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47402

Country

United States

Facility Name

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52402

Country

United States

Facility Name

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

City

Ashland

State/Province

Kentucky

ZIP/Postal Code

41101

Country

United States

Facility Name

City

Mount Sterling

State/Province

Kentucky

ZIP/Postal Code

40353

Country

United States

Facility Name

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

City

Danvers

State/Province

Massachusetts

ZIP/Postal Code

01923

Country

United States

Facility Name

City

Framingham

State/Province

Massachusetts

ZIP/Postal Code

01701

Country

United States

Facility Name

City

Newton

State/Province

Massachusetts

ZIP/Postal Code

02462

Country

United States

Facility Name

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

City

Joplin

State/Province

Missouri

ZIP/Postal Code

64804

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

City

Latham

State/Province

New York

ZIP/Postal Code

12110

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43219

Country

United States

Facility Name

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001

Country

United States

Facility Name

City

Kingston

State/Province

Pennsylvania

ZIP/Postal Code

18704

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

Facility Name

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

Facility Name

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77702

Country

United States

Facility Name

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

City

El Paso

State/Province

Texas

ZIP/Postal Code

79915

Country

United States

Facility Name

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

City

Lewisville

State/Province

Texas

ZIP/Postal Code

75067

Country

United States

Facility Name

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

City

Midland

State/Province

Texas

ZIP/Postal Code

79701

Country

United States

Facility Name

City

Odessa

State/Province

Texas

ZIP/Postal Code

79761

Country

United States

Facility Name

City

Paris

State/Province

Texas

ZIP/Postal Code

75460

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Sherman

State/Province

Texas

ZIP/Postal Code

75090

Country

United States

Facility Name

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76310

Country

United States

Facility Name

City

Christiansburg

State/Province

Virginia

ZIP/Postal Code

24073

Country

United States

Facility Name

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

City

Lacey

State/Province

Washington

ZIP/Postal Code

98503

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99216

Country

United States

Facility Name

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1417EYG

Country

Argentina

Facility Name

City

Córdoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

City

Tucumain

ZIP/Postal Code

4000

Country

Argentina

Facility Name

City

Viedma

ZIP/Postal Code

8500

Country

Argentina

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Grimmenstein

ZIP/Postal Code

2840

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

A-1140

Country

Austria

Facility Name

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

City

Barretos

ZIP/Postal Code

14784700

Country

Brazil

Facility Name

City

Belo Horizonte

ZIP/Postal Code

31110580

Country

Brazil

Facility Name

City

Goiania

ZIP/Postal Code

74140050

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90430-090

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

1224010

Country

Brazil

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

City

Grenoble

ZIP/Postal Code

38049

Country

France

Facility Name

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06050

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

City

Bad Soden

ZIP/Postal Code

65812

Country

Germany

Facility Name

City

Bielefeld

ZIP/Postal Code

33611

Country

Germany

Facility Name

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

City

Gerlingen

ZIP/Postal Code

70839

Country

Germany

Facility Name

City

Großhansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

City

Immenhausen

ZIP/Postal Code

34376

Country

Germany

Facility Name

City

Oldenburg

ZIP/Postal Code

26121

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

City

Villingen-Schwenningen

ZIP/Postal Code

78050

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

City

Chania

ZIP/Postal Code

73300

Country

Greece

Facility Name

City

Kifissia

ZIP/Postal Code

14564

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

City

Gyula

ZIP/Postal Code

5703

Country

Hungary

Facility Name

City

Matrahaza

ZIP/Postal Code

3233

Country

Hungary

Facility Name

City

Nyiregyhaza

ZIP/Postal Code

4412

Country

Hungary

Facility Name

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

City

Bangalore

ZIP/Postal Code

560099

Country

India

Facility Name

City

Cuttack

ZIP/Postal Code

753007

Country

India

Facility Name

City

Delhi

ZIP/Postal Code

110085

Country

India

Facility Name

City

Jaipur

ZIP/Postal Code

302017

Country

India

Facility Name

City

Kochin

ZIP/Postal Code

628040

Country

India

Facility Name

City

Madurai

ZIP/Postal Code

625020

Country

India

Facility Name

City

Mumbai

ZIP/Postal Code

400 012

Country

India

Facility Name

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

City

Trivandrum

ZIP/Postal Code

695 011

Country

India

Facility Name

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

City

Safed

ZIP/Postal Code

13110

Country

Israel

Facility Name

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

City

Livorno

ZIP/Postal Code

57124

Country

Italy

Facility Name

City

Monza

ZIP/Postal Code

20900

Country

Italy

Facility Name

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

City

Parma

ZIP/Postal Code

43100

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00152

Country

Italy

Facility Name

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

City

Suwon-City

ZIP/Postal Code

442-723

Country

Korea, Republic of

Facility Name

City

Guadalajara

ZIP/Postal Code

44280

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

Facility Name

City

Amsterdam

ZIP/Postal Code

1091AC

Country

Netherlands

Facility Name

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

City

Harderwijk

ZIP/Postal Code

3844 DG

Country

Netherlands

Facility Name

City

S-Hertogenbosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Facility Name

City

Zwolle

ZIP/Postal Code

80211 JW

Country

Netherlands

Facility Name

City

Grafton

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

City

Wellington

ZIP/Postal Code

6002

Country

New Zealand

Facility Name

City

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

City

Tromsø

ZIP/Postal Code

9012

Country

Norway

Facility Name

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

City

Gdynia

ZIP/Postal Code

81-519

Country

Poland

Facility Name

City

Glucholazy

ZIP/Postal Code

48-340

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

City

Opole

ZIP/Postal Code

45-060

Country

Poland

Facility Name

City

Otwock

ZIP/Postal Code

05-400

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

City

Bayamon

ZIP/Postal Code

00959

Country

Puerto Rico

Facility Name

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700106

Country

Romania

Facility Name

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

City

Stavropol

ZIP/Postal Code

355047

Country

Russian Federation

Facility Name

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

City

Mataró

ZIP/Postal Code

08304

Country

Spain

Facility Name

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

City

Pozuelo De Alarcon

ZIP/Postal Code

28223

Country

Spain

Facility Name

City

Eskilstuna

ZIP/Postal Code

63188

Country

Sweden

Facility Name

City

Linkoping

ZIP/Postal Code

58185

Country

Sweden

Facility Name

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

City

Solna

ZIP/Postal Code

17176

Country

Sweden

Facility Name

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

City

Fribourg

ZIP/Postal Code

1708

Country

Switzerland

Facility Name

City

Luzern

ZIP/Postal Code

CH-6000

Country

Switzerland

Facility Name

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

Facility Name

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

City

Kuei Shan Hsiang

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Neihu Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

City

Niao Sung Hsiang

ZIP/Postal Code

833

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11031

Country

Taiwan

Facility Name

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

City

Istanbul

ZIP/Postal Code

81540

Country

Turkey

Facility Name

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

City

Cottingham

State/Province

East Yorkshire

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

City

London

State/Province

Greater London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

City

Preston

State/Province

Lancashire

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

City

Wythenshawe

State/Province

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Facility Name

City

Scunthorpe

State/Province

North Lincolnshire

ZIP/Postal Code

DN15 7BH

Country

United Kingdom

Facility Name

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

City

Coventry

State/Province

West Midlands

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

City

Wolverhampton

State/Province

West Midlands

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

35930972

Citation

Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.

Results Reference

derived

PubMed Identifier

31958290

Citation

Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Perol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1):e000567. doi: 10.1136/esmoopen-2019-000567.

Results Reference

derived

PubMed Identifier

24933332

Citation

Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.

Results Reference

derived

PubMed Identifier

22853980

Citation

Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31.

Results Reference

derived

Learn more about this trial

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

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