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OpenTrials
Completed

NCT Number: NCT01769066

Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC

The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

Patients will be randomized to 2 groups

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18~70 years
  • Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
  • Presence of at least one index lesion measurable by CT scan or MRI
  • Ecog0-1
  • Expected life time longer than 12 weeks
  • Normal laboratory values:
  • leucocyte ≥ 4×109/L
  • neutrophil ≥ 1.5×109/L
  • platelet ≥ 100×109/L
  • Hemoglobin ≥ 10g/L
  • ALT and
  • AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
  • Signed written informed consent

Exclusion criteria

  • Patients have used drugs according to protocol
  • Patients were allergic to pemetrexed or cisplatin
  • Patients received radiotherapy or other biological treatment 4 weeks before the trial
  • Uncontrolled hydrothorax or hydropericardium
  • neuropathy toxicity ≥ CTC 3
  • Severe symptomatic heart disease
  • Active upper gastrointestinal ulcer or digestive disfunction
  • Severe infection or metabolic disfunction
  • Patients with other malignant tumor
  • Uncontrolled brain metastases
  • Patients have accepted other clinical trials
  • Female patients during their pregnant and lactation period, or patients without contraception

Treatment and study plan

Sequential Gefitinib With Pemetrexed/Platinum

Drug

Pemetrexed/Platinum

Drug

Primary outcomes

  1. 12 weeks of non-progression rate

    Time frame: from the first cycle of treatment (day one) to two month after the last cycle

Secondary outcomes

  1. PFS

    Time frame: from the first cycle of treatment (day one) to two month after the last cycle

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research

Important dates

Study start
2009
Primary completion
2014
First posted
Jan 16, 2013
Registry last updated
Feb 23, 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.

Published trials that share one or more normalized conditions with this study.