Clinical trial NCT01342965: A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m\^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m\^2 iv on Day 1.


Eligibility criteria: Inclusion Criteria:

* Adult participants, ≥ 18 years of age.
* Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
* Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
* European Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

* Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
* Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
* Any inflammatory changes of the surface of the eye.
* ≥ Grade 2 peripheral neuropathy.
* History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
* Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
* Human immunodeficiency virus (HIV) infection.
* Pregnant, nursing, or lactating women.

Primary outcomes:
measure: Investigator-assessed Duration of Progression-free Survival
timeFrame: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)
Secondary outcomes:
measure: Percentage of Responders as Assessed by the Investigator
timeFrame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
measure: Percentage of Participants With Disease Control
timeFrame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
measure: Duration of Response
timeFrame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
measure: Overall Survival
timeFrame: Baseline to the end of the study (3 years, 1 month)
measure: Safety: Incidence of Adverse Events
timeFrame: 36 months
measure: Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire
timeFrame: approximately 21 months
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Changchun
country: China
city: Chongqing
country: China
city: ChongQing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shantou
country: China
city: Wuhan
country: China
city: Xi'an
country: China
city: Kelantan
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Nilai
country: Malaysia
city: Pahang
country: Malaysia
city: Petaling Jaya, Selangor
country: Malaysia
city: Petaling Jaya
country: Malaysia
city: Pulau Pinang
country: Malaysia
city: Davao
country: Philippines
city: Desmarinas City
country: Philippines
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: San Juan
country: Philippines
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wen F, Zheng H, Zhang P, Hutton D, Li Q. OPTIMAL and ENSURE trials-based combined cost-effectiveness analysis of erlotinib versus chemotherapy for the first-line treatment of Asian patients with non-squamous non-small-cell lung cancer. BMJ Open. 2018 Apr 13;8(4):e020128. doi: 10.1136/bmjopen-2017-020128.
citation: Wu YL, Zhou C, Liam CK, Wu G, Liu X, Zhong Z, Lu S, Cheng Y, Han B, Chen L, Huang C, Qin S, Zhu Y, Pan H, Liang H, Li E, Jiang G, How SH, Fernando MCL, Zhang Y, Xia F, Zuo Y. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015 Sep;26(9):1883-1889. doi: 10.1093/annonc/mdv270. Epub 2015 Jun 23.