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; 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
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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Consent withdrawn	15	14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Consent Withdrawn	7	8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.
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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)
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 ]

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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 ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigator must discuss and obtain written consent of the sponsor on the intended publication. The investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of the submission in order to obtain approval.

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

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