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A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01328951
First received: April 4, 2011
Last updated: March 2, 2016
Last verified: March 2016
Results First Received: January 29, 2016  
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: Erlotinib
Drug: Second-Line Chemotherapy

  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
The study consisted of three periods: a Blinded Phase (BP), an Open-Label Phase (OLP), and final Survival Follow-Up (SFU). These periods were not necessarily sequential, because the OLP could be "skipped" in select participants. Therefore, the reasons for discontinuation are presented altogether within the Overall Study.

Reporting Groups
  Description
Late Erlotinib Participants received blinded placebo tablets orally (PO) once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
Early Erlotinib Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not epidermal growth factor receptor [EGFR] targeted therapies) or best supportive care (BSC) as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.

Participant Flow:   Overall Study
    Late Erlotinib     Early Erlotinib  
STARTED     321     322  
COMPLETED     0     0  
NOT COMPLETED     321     322  
Withdrawal Prior to Dose                 1                 1  
Disease Progression                 15                 11  
Adverse Event                 2                 0  
Death                 230                 241  
Lost to Follow-up                 5                 7  
Withdrawal by Subject                 5                 6  
Continuing Study as of Data Cut-Off                 63                 56  



  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.
Intent-to-Treat (ITT) Population: All participants who were randomized to treatment.

Reporting Groups
  Description
Late Erlotinib Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
Early Erlotinib Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
Total Total of all reporting groups

Baseline Measures
    Late Erlotinib     Early Erlotinib     Total  
Number of Participants  
[units: participants]
  321     322     643  
Age  
[units: years]
Mean (Standard Deviation)
  60.6  (9.1)     60.8  (8.8)     60.7  (8.9)  
Gender  
[units: participants]
     
Female     77     84     161  
Male     244     238     482  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Died During the Overall Study   [ Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) ]

2.  Primary:   Overall Survival (OS) as Median Time to Event During the Overall Study   [ Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) ]

3.  Primary:   Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study   [ Time Frame: At 1 year ]

4.  Secondary:   Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment   [ Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) ]

5.  Secondary:   Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment   [ Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) ]

6.  Secondary:   Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment   [ Time Frame: At 6 months ]

7.  Secondary:   Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment   [ Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) ]

8.  Secondary:   Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment   [ Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) ]

9.  Secondary:   Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment   [ Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) ]


  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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01328951     History of Changes
Other Study ID Numbers: BO25460
Study First Received: April 4, 2011
Results First Received: January 29, 2016
Last Updated: March 2, 2016
Health Authority: United States: Food and Drug Administration