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A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

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ClinicalTrials.gov Identifier: NCT01342965
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : February 24, 2015
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Erlotinib
Drug: Chemotherapy
Enrollment 217
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib Chemotherapy
Hide Arm/Group Description Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Period Title: Overall Study
Started 110 107
Received Treatment 110 104
Completed 1 0
Not Completed 109 107
Reason Not Completed
Death             58             57
Lost to Follow-up             5             3
Other Reasons- Unspecified             44             38
Withdrawal by Subject             2             9
Arm/Group Title Erlotinib Chemotherapy Total
Hide Arm/Group Description Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first. Total of all reporting groups
Overall Number of Baseline Participants 110 107 217
Hide Baseline Analysis Population Description
Full analysis set: All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 107 participants 217 participants
56.7  (10.37) 55.8  (10.41) 56.3  (10.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 107 participants 217 participants
Female
68
  61.8%
65
  60.7%
133
  61.3%
Male
42
  38.2%
42
  39.3%
84
  38.7%
1.Primary Outcome
Title Investigator-assessed Duration of Progression-free Survival
Hide Description The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.
Time Frame Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants.
Arm/Group Title Erlotinib Chemotherapy
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Overall Number of Participants Analyzed 110 107
Median (95% Confidence Interval)
Unit of Measure: Months
11.0 [1] 
(8.3 to NA)
5.5
(4.2 to 7.1)
[1]
The upper limit of the confidence interval could not be estimated due to too few events.
2.Secondary Outcome
Title Percentage of Responders as Assessed by the Investigator
Hide Description A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.
Time Frame Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants.
Arm/Group Title Erlotinib Chemotherapy
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: Percentage of responders
68.2 39.3
3.Secondary Outcome
Title Percentage of Participants With Disease Control
Hide Description A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.
Time Frame Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants.
Arm/Group Title Erlotinib Chemotherapy
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: Percentage of participants
91.8 82.2
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
Time Frame Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants. Only participants who had a complete response or partial response were included in the analysis.
Arm/Group Title Erlotinib Chemotherapy
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Overall Number of Participants Analyzed 110 107
Median (95% Confidence Interval)
Unit of Measure: Months
10.8
(7.0 to 12.6)
4.2
(2.8 to 5.4)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time Frame Baseline to the end of the study (3 years, 1 month)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants.
Arm/Group Title Erlotinib Chemotherapy
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Overall Number of Participants Analyzed 110 107
Median (95% Confidence Interval)
Unit of Measure: Months
28.9
(25.8 to 30.5)
27.1
(25.4 to 30.9)
6.Secondary Outcome
Title Safety: Incidence of Adverse Events
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire
Hide Description [Not Specified]
Time Frame approximately 21 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Safety analysis set: All participants who had received at least 1 dose of study medication.
 
Arm/Group Title Erlotinib Chemotherapy
Hide Arm/Group Description Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
All-Cause Mortality
Erlotinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Erlotinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   22/110 (20.00%)   16/104 (15.38%) 
Blood and lymphatic system disorders     
Anaemia  1  1/110 (0.91%)  4/104 (3.85%) 
Thrombocytopenia  1  0/110 (0.00%)  3/104 (2.88%) 
Cardiac disorders     
Angina pectoris  1  1/110 (0.91%)  0/104 (0.00%) 
Pericardial effusion  1  1/110 (0.91%)  0/104 (0.00%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/110 (0.91%)  0/104 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  3/110 (2.73%)  0/104 (0.00%) 
Upper gastrointestinal haemorrhage  1  2/110 (1.82%)  0/104 (0.00%) 
Small intestinal haemorrhage  1  1/110 (0.91%)  0/104 (0.00%) 
Vomiting  1  0/110 (0.00%)  1/104 (0.96%) 
General disorders     
Chest pain  1  1/110 (0.91%)  0/104 (0.00%) 
Pyrexia  1  1/110 (0.91%)  0/104 (0.00%) 
Infections and infestations     
Gastroenteritis  1  2/110 (1.82%)  1/104 (0.96%) 
Pneumonia  1  3/110 (2.73%)  0/104 (0.00%) 
Abscess limb  1  1/110 (0.91%)  0/104 (0.00%) 
Gastrointestinal infection  1  1/110 (0.91%)  0/104 (0.00%) 
Haemorrhoid infection  1  1/110 (0.91%)  0/104 (0.00%) 
Localised infection  1  1/110 (0.91%)  0/104 (0.00%) 
Nail bed infection  1  1/110 (0.91%)  0/104 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  1/110 (0.91%)  0/104 (0.00%) 
Soft tissue injury  1  1/110 (0.91%)  0/104 (0.00%) 
Investigations     
Blood glucose increased  1  1/110 (0.91%)  0/104 (0.00%) 
Platelet count decreased  1  0/110 (0.00%)  1/104 (0.96%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  1/110 (0.91%)  0/104 (0.00%) 
Hypokalaemia  1  0/110 (0.00%)  1/104 (0.96%) 
Musculoskeletal and connective tissue disorders     
Bone erosion  1  1/110 (0.91%)  0/104 (0.00%) 
Bone pain  1  1/110 (0.91%)  0/104 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  0/110 (0.00%)  1/104 (0.96%) 
Nervous system disorders     
Spinal cord compression  1  1/110 (0.91%)  0/104 (0.00%) 
Psychiatric disorders     
Bipolar disorder  1  1/110 (0.91%)  0/104 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/110 (2.73%)  0/104 (0.00%) 
Pleural effusion  1  2/110 (1.82%)  0/104 (0.00%) 
Pneumonitis  1  1/110 (0.91%)  1/104 (0.96%) 
Respiratory failure  1  0/110 (0.00%)  2/104 (1.92%) 
Pulmonary embolism  1  1/110 (0.91%)  0/104 (0.00%) 
Surgical and medical procedures     
Haemorrhoid operation  1  1/110 (0.91%)  0/104 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  0/110 (0.00%)  2/104 (1.92%) 
Thrombosis  1  0/110 (0.00%)  1/104 (0.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   99/110 (90.00%)   96/104 (92.31%) 
Blood and lymphatic system disorders     
Leukopenia  1  7/110 (6.36%)  51/104 (49.04%) 
Neutropenia  1  5/110 (4.55%)  53/104 (50.96%) 
Anaemia  1  8/110 (7.27%)  44/104 (42.31%) 
Thrombocytopenia  1  2/110 (1.82%)  18/104 (17.31%) 
Gastrointestinal disorders     
Nausea  1  5/110 (4.55%)  60/104 (57.69%) 
Vomiting  1  7/110 (6.36%)  56/104 (53.85%) 
Diarrhoea  1  49/110 (44.55%)  9/104 (8.65%) 
Constipation  1  2/110 (1.82%)  19/104 (18.27%) 
Mouth ulceration  1  6/110 (5.45%)  3/104 (2.88%) 
Stomatitis  1  6/110 (5.45%)  0/104 (0.00%) 
General disorders     
Fatigue  1  6/110 (5.45%)  20/104 (19.23%) 
Pyrexia  1  8/110 (7.27%)  13/104 (12.50%) 
Chest discomfort  1  6/110 (5.45%)  3/104 (2.88%) 
Infections and infestations     
Paronychia  1  17/110 (15.45%)  0/104 (0.00%) 
Investigations     
White blood cell count decreased  1  3/110 (2.73%)  16/104 (15.38%) 
Alanine aminotransferase increased  1  13/110 (11.82%)  2/104 (1.92%) 
Platelet count decreased  1  1/110 (0.91%)  14/104 (13.46%) 
Aspartate aminotransferase increased  1  11/110 (10.00%)  3/104 (2.88%) 
Neutrophil count decreased  1  2/110 (1.82%)  10/104 (9.62%) 
Blood bilirubin increased  1  11/110 (10.00%)  0/104 (0.00%) 
Haemoglobin decreased  1  0/110 (0.00%)  6/104 (5.77%) 
Metabolism and nutrition disorders     
Decreased appetite  1  14/110 (12.73%)  30/104 (28.85%) 
Hypokalaemia  1  6/110 (5.45%)  7/104 (6.73%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  8/110 (7.27%)  6/104 (5.77%) 
Nervous system disorders     
Dizziness  1  7/110 (6.36%)  14/104 (13.46%) 
Headache  1  5/110 (4.55%)  7/104 (6.73%) 
Psychiatric disorders     
Insomnia  1  5/110 (4.55%)  8/104 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  19/110 (17.27%)  9/104 (8.65%) 
Skin and subcutaneous tissue disorders     
Rash  1  78/110 (70.91%)  11/104 (10.58%) 
Pruritus  1  11/110 (10.00%)  7/104 (6.73%) 
Alopecia  1  6/110 (5.45%)  10/104 (9.62%) 
Dry skin  1  10/110 (9.09%)  2/104 (1.92%) 
Dermatitis acneiform  1  9/110 (8.18%)  0/104 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01342965    
Other Study ID Numbers: YO25121
First Submitted: April 26, 2011
First Posted: April 27, 2011
Results First Submitted: February 5, 2015
Results First Posted: February 24, 2015
Last Update Posted: February 24, 2015