A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00556712
First received: November 9, 2007
Last updated: January 27, 2015
Last verified: January 2015
Results First Received: December 4, 2014  
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-Small Cell Lung Cancer
Interventions: Drug: erlotinib [Tarceva]
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
Placebo Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Erlotinib, 150 Milligrams Per Day (mg/Day) Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.

Participant Flow:   Overall Study
    Placebo     Erlotinib, 150 Milligrams Per Day (mg/Day)  
STARTED     451     438  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     451     438  
Adverse Event                 7                 19  
Death                 5                 10  
Progressive Disease                 383                 320  
Protocol Violation                 3                 2  
Refused Treatment                 17                 16  
Failure to Return                 2                 3  
Not Specified                 2                 2  
Ongoing at Data Cutoff                 32                 66  
[1] Data cutoff date: 17 May 2008



  Baseline Characteristics
  Hide Baseline Characteristics

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): all randomized participants presented according to the therapy that they were randomized to receive

Reporting Groups
  Description
Placebo Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Erlotinib, 150 mg/Day Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Total Total of all reporting groups

Baseline Measures
    Placebo     Erlotinib, 150 mg/Day     Total  
Number of Participants  
[units: participants]
  451     438     889  
Age  
[units: years]
Mean (Standard Deviation)
  59.7  (9.39)     59.8  (9.52)     59.8  (9.44)  
Gender  
[units: participants]
     
Female     113     117     230  
Male     338     321     659  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

2.  Primary:   PFS in All Participants (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

3.  Primary:   Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)   [ Time Frame: 6 months ]

4.  Primary:   Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

5.  Primary:   PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

6.  Primary:   Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)   [ Time Frame: 6 months ]

7.  Secondary:   Percentage of All Participants Who Died (Data Cutoff 12 January 2012)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months). ]

8.  Secondary:   Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)   [ Time Frame: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) ]

9.  Secondary:   Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)   [ Time Frame: 1 year ]

10.  Secondary:   Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) ]

11.  Secondary:   OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) ]

12.  Secondary:   Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)   [ Time Frame: 1 year ]

13.  Secondary:   Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months) ]

14.  Secondary:   PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

15.  Secondary:   Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)   [ Time Frame: 6 months ]

16.  Secondary:   Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

17.  Secondary:   OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

18.  Secondary:   Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)   [ Time Frame: 1 year ]

19.  Secondary:   Time to Progression (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

20.  Secondary:   Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)   [ Time Frame: 6 months ]

21.  Secondary:   Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

22.  Secondary:   Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

23.  Secondary:   Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

24.  Secondary:   Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

25.  Secondary:   Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

26.  Secondary:   Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

27.  Secondary:   Time to Symptom Progression (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

28.  Secondary:   Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)   [ Time Frame: 6 months ]

29.  Secondary:   Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

30.  Secondary:   Time to Deterioration in TOI (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

31.  Secondary:   Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)   [ Time Frame: 6 months ]

32.  Secondary:   Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

33.  Secondary:   Time to Deterioration in QoL (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

34.  Secondary:   Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)   [ Time Frame: 6 months ]

35.  Secondary:   Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]

36.  Secondary:   Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)   [ Time Frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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 by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00556712     History of Changes
Other Study ID Numbers: BO18192
Study First Received: November 9, 2007
Results First Received: December 4, 2014
Last Updated: January 27, 2015
Health Authority: Russia: Ministry of Health