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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: April 17, 2014
Last verified: April 2014
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Consent withdrawn                 15                 14  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Consent Withdrawn                 7                 8  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  
Number of Participants  
[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 ]

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
No text entered.


  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


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00863746     History of Changes
Other Study ID Numbers: 13266, 2008-006914-62
Study First Received: March 17, 2009
Results First Received: April 10, 2013
Last Updated: April 17, 2014
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