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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ImClone LLC
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01168973
First received: July 16, 2010
Last updated: February 10, 2016
Last verified: February 2016
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Biological: Ramucirumab
Drug: Placebo (for Ramucirumab)
Drug: Docetaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who died, due to any cause, or were alive at the end of the study but off study drug were considered to have completed the study.

Reporting Groups
  Description
Ramucirumab and Docetaxel

On Day 1 of each 21-day cycle, participants received ramucirumab drug product (DP) followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

  • Ramucirumab DP: 10 milligrams per kilogram (mg/kg) administered intravenously.
  • Docetaxel: 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 intravenously.
Placebo and Docetaxel

On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

  • Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
  • Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

Participant Flow:   Overall Study
    Ramucirumab and Docetaxel     Placebo and Docetaxel  
STARTED     628     625  
Received Any Quantity of Any Study Drug     624     621 [1]
COMPLETED     594     592  
NOT COMPLETED     34     33  
Alive on treatment after data-cutoff                 11                 10  
Lost to Follow-up                 10                 9  
Withdrawal of consent without follow-up                 13                 14  
[1] Three participants randomized to placebo and docetaxel received 1 dose of ramucirumab in error.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization.

Reporting Groups
  Description
Ramucirumab and Docetaxel

On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

  • Ramucirumab DP: 10 mg/kg administered intravenously.
  • Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
Placebo and Docetaxel

On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

  • Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
  • Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
Total Total of all reporting groups

Baseline Measures
    Ramucirumab and Docetaxel     Placebo and Docetaxel     Total  
Number of Participants  
[units: participants]
  628     625     1253  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     391     407     798  
>=65 years     237     218     455  
Gender  
[units: participants]
     
Female     209     210     419  
Male     419     415     834  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     43     53     96  
Not Hispanic or Latino     387     380     767  
Unknown or Not Reported     198     192     390  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     9     20     29  
Asian     74     86     160  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     17     16     33  
White     526     503     1029  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     156     152     308  
Taiwan     9     18     27  
Greece     25     19     44  
Spain     27     23     50  
Israel     14     8     22  
Russian Federation     28     33     61  
Italy     26     28     54  
Switzerland     12     14     26  
India     22     33     55  
France     21     24     45  
Puerto Rico     1     2     3  
Netherlands     15     16     31  
Korea, Republic of     34     28     62  
Turkey     22     23     45  
Austria     11     9     20  
United Kingdom     19     19     38  
Hungary     9     4     13  
Mexico     11     20     31  
Canada     12     7     19  
Argentina     16     17     33  
Brazil     4     3     7  
Poland     30     33     63  
Romania     41     36     77  
Norway     10     3     13  
Germany     40     42     82  
New Zealand     3     4     7  
Sweden     10     7     17  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Randomization to date of death from any cause (up to 34 months) ]

2.  Secondary:   Progression-Free Survival (PFS) Time   [ Time Frame: Randomization to measured PD or date of death from any cause (up to 29 months) ]

3.  Secondary:   Percentage of Participants Achieving an Objective Response (Objective Response Rate)   [ Time Frame: Baseline to measured PD (up to 29 months) ]

4.  Secondary:   Percentage of Participants Achieving Disease Control (Disease Control Rate)   [ Time Frame: Baseline to measured PD (up to 29 months) ]

5.  Secondary:   Maximum Improvement on Lung Cancer Symptom Scale (LCSS)   [ Time Frame: Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle) ]

6.  Secondary:   Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores   [ Time Frame: Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle) ]

7.  Secondary:   Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab   [ Time Frame: Prior to infusion and 1 hour following infusion for Cycles 3 and 5 (21 days/cycle) ]

8.  Secondary:   Number of Participants With Anti-Ramucirumab Antibodies   [ Time Frame: Baseline, prior to infusion for Cycles 3 and 5, and 30 days following last infusion (up to Cycle 38, 21 days/cycle) ]

9.  Other Pre-specified:   Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died   [ Time Frame: First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Three participants randomized to placebo and docetaxel received 1 dose of ramucirumab in error. They are included in the placebo and docetaxel arm in the ITT population and are included in the ramucirumab and docetaxel arm in the Safety population.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01168973     History of Changes
Other Study ID Numbers: 13852
I4T-MC-JVBA ( Other Identifier: Eli Lilly and Company )
2010-021297-11 ( EudraCT Number )
CP12-1027 ( Other Identifier: ImClone Trial Number )
CTRI/2011/08/001942 ( Registry Identifier: Clinical Trials Registry India )
Study First Received: July 16, 2010
Results First Received: December 17, 2014
Last Updated: February 10, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
France: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Mexico: Secretaria de Salud
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration