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Completed

NCT Number: NCT01498562

Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance hospital, Yonsei Cancer Center

Seoul, South Korea

About this study

Reversible EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, were shown to be effective in patients with non-small cell lung cancer (NSCLC). However, patients almost invariably develop resistance to TKIs and have disease progression. Nimotuzumab is a humanized monoclonal antibody targeting the EGFR.

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of written informed consent prior to any study specific procedures
  • Unresectable non-small cell lung cancer
  • ECOG performance status of 0 to 2
  • Male or female; ≥ 20 years of age
  • Subjects whose disease has progressed after platinum-based chemotherapy
  • Subjects with measurable lesion

Exclusion criteria

  • Inadequate organ functions
  • Disease progression after 2 or more previous chemotherapy regimens
  • Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab
  • Any clinically significant gastrointestinal abnormalities
  • Past medical history of interstitial lung disease
  • Pregnant or lactating female

Treatment and study plan

Gefitinib and Nimotuzumab

Drug

Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)

Other names: h-R3

Gefitinib

Drug

Mono-therapy group: Gefitinib(250mg daily)

Other names: Iressa

Primary outcomes

  1. Progression free survival rate at 3 months

    Time frame: 3 months after randomization of last patient

    The progression-free survival rate at 3 months of the patients with no progression of disease or death due to any cause until 3 months is elapsed after being randomized.

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: 3 months after randomization of last patient

    Progression free survival (PFS) defined as the time from randomized date to the progression date or the preceded date of death date due to any cause.

  2. Overall survival (OS)

    Time frame: 3 months after randomization of last patient

    Overall survival (OS) defined as the period from randomly assigned point of time to the date of death due to any cause.

  3. Overall safety profile

    Time frame: 3 months after randomization of last patient

    Overall safety profile verified as relevance of adverse events and laboratory abnormality in the study and grades granted based on (USA National Cancer Center) Common Terminology Criteria for Adverse Events such as the type, frequency and severity (CTCAE), v4.0.

  4. Objective response rate (ORR)

    Time frame: 3 months after randomization of last patient

    Overall objective response rate (ORR) is the best response rate stipulated as complete response (CR) or partial response (PR) (target lesion and tumor response defined according to RECIST guideline version 1.1) and identified as percentage of the confirmed patients.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Randomized Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Patients With Advanced Non-small Cell Lung Cancer: Dual-agent Molecular Targeting of EGFR (DATE)

Acronym: DATE

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2011
Registry last updated
Dec 2, 2014

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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