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

Phase 2

Completed

• Conditions: NSCLC
• Interventions: Drug: Pemetrexed/Platinum; Drug: Sequential Gefitinib With Pemetrexed/Platinum

• Registration Number: NCT01769066
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Patients will be randomized to 2 groups

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Primary Completion: 2014-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pemetrexed/Platinum	Pemetrexed/Platinum	Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1
Sequential Gefitinib With Pemetrexed/Platinum	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

Primary Outcome Measures

Name	Time	Method
12 weeks of non-progression rate	from the first cycle of treatment (day one) to two month after the last cycle

Secondary Outcome Measures

Name	Time	Method
PFS	from the first cycle of treatment (day one) to two month after the last cycle

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China