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

NCT ID: NCT01342965

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib

Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib was supplied as tablets.

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.

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

Cisplatin and gemcitabine were locally sourced with commercial products.

Interventions

Erlotinib

Erlotinib was supplied as tablets.

Intervention Type: DRUG

Chemotherapy

Cisplatin and gemcitabine were locally sourced with commercial products.

Intervention Type: DRUG

Other Intervention Names

Tarceva

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beijing, , China

Beijing, , China

Changchun, , China

Chongqing, , China

Chongqing, , China

Fuzhou, , China

Guangzhou, , China

Hangzhou, , China

Nanjing, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Shantou, , China

Wuhan, , China

Xi'an, , China

Kampung Baharu Nilai, , Malaysia

Kelantan, , Malaysia

Kuala Lumpur, , Malaysia

Kuala Lumpur, , Malaysia

Kuala Pahang, , Malaysia

Petaling Jaya, , Malaysia

Petaling Jaya, Selangor, , Malaysia

Pulau Pinang, , Malaysia

Davao City, , Philippines

Desmarinas City, , Philippines

Manila, , Philippines

Quezon City, , Philippines

San Juan City, , Philippines

Countries

China; Malaysia; Philippines

References

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.

Reference Type: DERIVED

PMID: 29654023 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26105600 (View on PubMed)

Other Identifiers

YO25121

Identifier Type: -

Identifier Source: org_study_id