A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
|ClinicalTrials.gov Identifier: NCT01342965|
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : February 24, 2015
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Erlotinib Drug: Chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||April 2014|
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Erlotinib was supplied as tablets.
Other Name: Tarceva
Active Comparator: Chemotherapy
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.
Cisplatin and gemcitabine were locally sourced with commercial products.
- Investigator-assessed Duration of Progression-free Survival [ Time Frame: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months) ]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.
- Percentage of Responders as Assessed by the Investigator [ Time Frame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) ]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.
- Percentage of Participants With Disease Control [ Time Frame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) ]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.
- Duration of Response [ Time Frame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) ]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.
- Overall Survival [ Time Frame: Baseline to the end of the study (3 years, 1 month) ]Overall survival was defined as the time from the date of randomization to the date of death from any cause.
- Safety: Incidence of Adverse Events [ Time Frame: 36 months ]
- Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire [ Time Frame: approximately 21 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342965
|Beijing, China, 100071|
|Beijing, China, 101149|
|Changchun, China, 130012|
|Chongqing, China, 400038|
|ChongQing, China, 400042|
|Fuzhou, China, 350014|
|Guangzhou, China, 510080|
|Hangzhou, China, 310016|
|Nanjing, China, 210002|
|Shanghai, China, 200030|
|Shanghai, China, 200032|
|Shanghai, China, 200433|
|Shantou, China, 515041|
|Wuhan, China, 430023|
|Xi'an, China, 710061|
|Kelantan, Malaysia, 16150|
|Kuala Lumpur, Malaysia, 50603|
|Kuala Lumpur, Malaysia, 59100|
|Nilai, Malaysia, 71800|
|Pahang, Malaysia, 25100|
|Petaling Jaya, Selangor, Malaysia, 46050|
|Petaling Jaya, Malaysia, 46150|
|Pulau Pinang, Malaysia, 11600|
|Davao, Philippines, 8000|
|Desmarinas City, Philippines, 4114|
|Manila, Philippines, 1000|
|Quezon City, Philippines, 1104|
|San Juan, Philippines, 1500|
|Study Director:||Clinical Trials||Hoffmann-La Roche|