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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University Identifier:
First received: January 10, 2013
Last updated: May 12, 2013
Last verified: May 2013

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

Condition Intervention Phase
Drug: Sequential Gefitinib With Pemetrexed/Platinum
Drug: Pemetrexed/Platinum
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 12 weeks of non-progression rate [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: December 2009
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequential Gefitinib With Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ,DAY2 DDP IV 75mg/m2 ,DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16
Drug: Sequential Gefitinib With Pemetrexed/Platinum
Active Comparator: Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ,DAY2 DDP IV 75mg/m2 ,DAY1 OR CAP IV AUC 5,DAY1
Drug: Pemetrexed/Platinum

Detailed Description:

Patients will be randomized to 2 groups


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18~70 years
  2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-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)
  7. 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01769066

China, Shanghai
Cancer hospital Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Chang jian hua, MD,PhD Cancer hospital Fudan University
  More Information

No publications provided

Responsible Party: Chang Jian Hua, Deputy director of department of medical oncology, Fudan University Identifier: NCT01769066     History of Changes
Other Study ID Numbers: Gefitinib-2009-cjh
Study First Received: January 10, 2013
Last Updated: May 12, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 20, 2014