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A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00883779
First received: April 15, 2009
Last updated: November 10, 2015
Last verified: November 2015
Results First Received: November 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Non-Squamous Non-Small Cell Lung Cancer
Interventions: Drug: Placebo
Drug: Platinum chemotherapy (cisplatin or carboplatin)
Drug: erlotinib [Tarceva]
Drug: gemcitabine

  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
Placebo Participants received 1250 milligrams per squared meter (mg/m^2) of gemcitabine intravenous (IV) infusion on Day 1 and 8, carboplatin 5 times (5x) area under concentration versus time curve (AUC) or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day Cycle) until disease progression (PD), unacceptable toxicity or death in primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
Erlotinib Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 milligrams per day (mg/day) from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).

Participant Flow for 3 periods

Period 1:   Primary Study Treatment Phase
    Placebo     Erlotinib  
STARTED     225     226  
COMPLETED     120     140  
NOT COMPLETED     105     86  
Did not receive allocated intervention                 4                 4  
Disease progression                 75                 59  
Adverse Event                 16                 16  
Death                 2                 3  
Refused Treatment                 5                 4  
Unspecified                 3                 0  

Period 2:   Post-Study Treatment Phase
    Placebo     Erlotinib  
STARTED     112     135  
COMPLETED     0     0  
NOT COMPLETED     112     135  
Adverse Event                 2                 3  
Death                 1                 3  
Protocol Violation                 0                 1  
Refused Treatment                 3                 0  
Disease progression                 103                 122  
Unspecified                 3                 0  
Ongoing in the study                 0                 6  

Period 3:   Off-study Phase
    Placebo     Erlotinib  
STARTED     209     202  
COMPLETED     0     0  
NOT COMPLETED     209     202  
Death                 185                 174  
Refused treatment                 1                 1  
Failure to return                 5                 6  
Unspecified                 18                 21  



  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.
Full analysis set (FAS) population (Included all enrolled participants).

Reporting Groups
  Description
Placebo Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
Erlotinib Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
Total Total of all reporting groups

Baseline Measures
    Placebo     Erlotinib     Total  
Number of Participants  
[units: participants]
  225     226     451  
Age  
[units: years]
Mean (Standard Deviation)
  56.4  (11.08)     57.2  (9.71)     56.8  (10.41)  
Gender  
[units: participants]
     
Female     85     94     179  
Male     140     132     272  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Progression Free Survival (PFS) Time   [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]

2.  Secondary:   Percentage of Participants Alive and Free From Disease Progression   [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]

3.  Secondary:   Median PFS Time Based on Different Subgroups   [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]

4.  Secondary:   Median Overall Survival (OS) Time-Overall and Among Different Subgroups   [ Time Frame: Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years]) ]

5.  Secondary:   Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups   [ Time Frame: Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years]) ]

6.  Secondary:   Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks   [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]

7.  Secondary:   Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR   [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]

8.  Secondary:   Duration of Response   [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]

9.  Secondary:   Time to Progression   [ Time Frame: Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years]) ]

10.  Secondary:   Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)   [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]

11.  Secondary:   Time to Symptomatic Progression   [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]

12.  Secondary:   Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0   [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]

13.  Secondary:   Time to Deterioration in TOI Using FACT-L Version 4.0   [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]

14.  Secondary:   Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0   [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]

15.  Secondary:   Time to Deterioration in QOL Using FACT-L Version 4.0   [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]

16.  Secondary:   Median Follow-up Time During the Study   [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years]) ]


  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: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00883779     History of Changes
Other Study ID Numbers: MO22201
Study First Received: April 15, 2009
Results First Received: November 10, 2015
Last Updated: November 10, 2015
Health Authority: Hong Kong: Department of Health