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Completed

NCT Number: NCT02000531

Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population

This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant in ENSURE trial
  • Disease progression during first-line treatment

Exclusion criteria

  • N/A

Treatment and study plan

Erlotinib

Drug

150 mg oral dose of erlotinib given once daily

Other names: Tarceva

Chemotherapy

Drug

Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)

Other names: Gemcitabine/Cisplatin

Primary outcomes

  1. Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events

    Time frame: within 3 years, 9 months (data cut-off December 2014)

    Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.

Secondary outcomes

  1. Participants With Adverse Events

    Time frame: start of second-line treatment to data cut-off in December 2014 (within 12 months)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2013
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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