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

Last updated: February 22, 2016
Sponsor: Fudan University
Overall Status: Completed

Phase

2/3

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT01769066
Gefitinib-2009-cjh
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18~70 years

  2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IVnon-small cell lung cancer

  3. Presence of at least one index lesion measurable by CT scan or MRI

  4. Ecog0-1

  5. Expected life time longer than 12 weeks

  6. 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)

  1. Signed written informed consent

Exclusion

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 withoutcontraception

Study Design

Total Participants: 117
Study Start date:
December 01, 2009
Estimated Completion Date:

Study Description

Patients will be randomized to 2 groups

Connect with a study center

  • Cancer hospital Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

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