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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769066
• Other study ID #: Gefitinib-2009-cjh
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 10, 2013
• Last updated: February 22, 2016
• Start date: December 2009

Study information

• Verified date: February 2016
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be randomized to 2 groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Sequential Gefitinib With Pemetrexed/Platinum

• Pemetrexed/Platinum

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 weeks of non-progression rate		from the first cycle of treatment (day one) to two month after the last cycle	No
Secondary	PFS		from the first cycle of treatment (day one) to two month after the last cycle	No