A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This study has been terminated.
(Study was stopped due to slower than expected recruitment.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940875
First received: July 6, 2009
Last updated: April 1, 2015
Last verified: April 2015
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: 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
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
Gemcitabine Monotherapy Participants received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
Gemcitabine (G) Plus (+) Erlotinib (E) Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, orally (PO), once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Participant Flow for 2 periods

Period 1:   Treatment Phase
    Gemcitabine Monotherapy     Gemcitabine (G) Plus (+) Erlotinib (E)  
STARTED     31 [1]   23 [2]
COMPLETED     5     4  
NOT COMPLETED     26     19  
Adverse Event                 9                 3  
Death                 3                 5  
Lack of Efficacy                 1                 0  
Withdrawal by Subject                 3                 0  
Disease progression                 9                 11  
Physician Decision                 1                 0  
[1] Disposition analysis includes 3 participants randomized to G+E but received only gemcitabine
[2] 3 participants randomized to G+E arm received only gemcitabine and were analyzed in Gemcitabine arm

Period 2:   Post-Study Treatment
    Gemcitabine Monotherapy     Gemcitabine (G) Plus (+) Erlotinib (E)  
STARTED     0     4  
COMPLETED     0     1  
NOT COMPLETED     0     3  
Death                 0                 1  
Disease Progression                 0                 2  



  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) (following an intent-to-treat principle): all randomized participants.

Reporting Groups
  Description
Gemcitabine Monotherapy Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
Gemcitabine + Erlotinib Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
Total Total of all reporting groups

Baseline Measures
    Gemcitabine Monotherapy     Gemcitabine + Erlotinib     Total  
Number of Participants  
[units: participants]
  28     26     54  
Age  
[units: years]
Mean (Standard Deviation)
  74.8  (8.72)     72.8  (7.91)     73.8  (8.32)  
Gender  
[units: participants]
     
Female     12     10     22  
Male     16     16     32  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Disease Progression or Death   [ Time Frame: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant). ]

2.  Primary:   PFS   [ Time Frame: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years) ]

3.  Secondary:   Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0   [ Time Frame: BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant). ]

4.  Secondary:   Percentage of Participants With Non-Progression at Weeks 8 and 16   [ Time Frame: Weeks 8 and 16 ]

5.  Secondary:   Percentage of Participants Who Died   [ Time Frame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years. ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years. ]

7.  Secondary:   Duration of Response   [ Time Frame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 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
Due to slower than expected recruitment, this study was stopped after 54 patients had been enrolled.


  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: Hoffman-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940875     History of Changes
Other Study ID Numbers: ML22429
Study First Received: July 6, 2009
Results First Received: December 19, 2014
Last Updated: April 1, 2015
Health Authority: Australia: National Health and Medical Research Council