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A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC). (MISSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00863746
First received: March 17, 2009
Last updated: January 7, 2015
Last verified: January 2015
History of Changes
Results First Received: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Carcinoma
Non-Small-Cell Lung
Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Placebo Participants received 2 tablets of placebo orally twice daily (BID)

Participant Flow for 2 periods

 Period 1:   Treatment
    Sorafenib (Nexavar, BAY43-9006)   Placebo
STARTED   350   353 
Participants Received Treatment   346 [1]   351 [1] 
COMPLETED   279   318 
NOT COMPLETED   71   35 
Not treated                4                2 
Adverse Event                41                16 
non-compliant with study medication                4                0 
Consent withdrawn                15                14 
Lost to Follow-up                1                0 
Protocol Violation                5                3 
not available                1                0 
[1] Safety population

Period 2:   Survival Follow up
    Sorafenib (Nexavar, BAY43-9006)   Placebo
STARTED   298 [1]   331 [2] 
COMPLETED   45   51 
NOT COMPLETED   253   280 
Death                244                271 
Lost to Follow-up                2                1 
Consent Withdrawn                7                8 
[1] 298 patients of 317 patients (= 346 randomized - 29 deaths) entered the survival follow-up
[2] 331 patients of 339 patients (=353 randomized - 14 death) entered the survival follow-up.



  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.
No text entered.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Placebo Participants received 2 tablets of placebo orally twice daily (BID)
Total Total of all reporting groups

Baseline Measures
   Sorafenib (Nexavar, BAY43-9006)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 350   353   703 
Age 
[Units: Years]
Mean (Standard Deviation) 		 58.9  (10.7)   60.9  (9.8)   59.9  (10.3) 
Age, Customized 
[Units: Participants]
 		     
< 65 years   239   222   461 
>= 65 and < 75 years   91   102   193 
>= 75 years   20   29   49 
Gender 
[Units: Participants]
 		     
Female   164   144   308 
Male   186   209   395 
Region (CRF [case report form]) 
[Units: Participants]
 		     
Group 1 (North America, Northern/Western Europe)   122   119   241 
Group 2 (S. America, Eastern Europe, Asia-Pacific)   228   234   462 
Number of participants with prior anti-cancer therapy and diagnostic procedures 
[Units: Participants]
 		     
2 regimens   188   197   385 
3 regimens   158   153   311 
4 regimens   3   3   6 
5 regimens   1   0   1 
Brain metastasis 
[Units: Participants]
 		     
No   293   299   592 
Yes   56   54   110 
Missing   1   0   1 
Prior EGFR (Epidermal Growth Factor Receptor) inhibitor treatment 
[Units: Participants]
 		     
No   141   146   287 
Yes   209   207   416 
ECOG (Eastern Cooperative Oncology Group) performance status [1] 
[Units: Participants]
 		     
Missing   6   1   7 
0   110   110   220 
1   233   242   475 
2   1   0   1 
[1] A scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization of the first subject until 36 months later ]
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2.  Secondary:   Progression-free Survival   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]
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3.  Secondary:   Disease Control   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]
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4.  Secondary:   Objective Tumor Response   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]
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5.  Secondary:   Time to Progression   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status   [ Time Frame: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) ]
  Show Outcome Measure 6

7.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale   [ Time Frame: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) ]
  Show Outcome Measure 7

8.  Secondary:   Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea   [ Time Frame: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score   [ Time Frame: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score   [ Time Frame: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  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
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  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: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com



Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00863746     History of Changes
Other Study ID Numbers: 13266
2008-006914-62 ( EudraCT Number )
Study First Received: March 17, 2009
Results First Received: April 10, 2013
Last Updated: January 7, 2015