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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
Results First Received: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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)

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Consent withdrawn                15                14 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Consent Withdrawn                7                8 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 
 110   110   220 
 233   242   475 
 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 ]

2.  Secondary:   Progression-free Survival   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]

3.  Secondary:   Disease Control   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]

4.  Secondary:   Objective Tumor Response   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]

5.  Secondary:   Time to Progression   [ Time Frame: From randomization of the first subject until 36 months later assessed every 6 weeks ]

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) ]

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) ]

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) ]

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) ]

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) ]


  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
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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
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentosy Tecnologia Medica
Austria: Ethikkommission
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Greece: Ethics Committee
Hong Kong: Department of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: National Institute of Health Sciences
Korea: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Ministry of Health
United States: Food and Drug Administration
Singapore: Health Sciences Authority
Pakistan: Ministry of Health
Phillipines: Department of Health
Taiwan: Department of Health
Thailand: Food and Drug Administration
Hungry: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Turkey: Ethics Committee
Sweden: Ethikkommission
Spain: Spanish Agency of Medicines
Russia: Ethics Committee
South Africa: Human Research Ethics Committee
Poland: Ministry of Health