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

Fudan University

Status and phase: Completed; Phase 3; Phase 2

Conditions: NSCLC

Treatments: Drug: Pemetrexed/Platinum; Drug: Sequential Gefitinib With Pemetrexed/Platinum

Study type: Interventional

Funder types: Other

Identifiers

NCT01769066

Gefitinib-2009-cjh

Details and patient eligibility

About

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

Full description

Patients will be randomized to 2 groups

Enrollment: 117 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Sequential Gefitinib With Pemetrexed/Platinum

Experimental group

Description:

Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16

Treatment:

Drug: Sequential Gefitinib With Pemetrexed/Platinum

Pemetrexed/Platinum

Active Comparator group

Description:

Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1

Treatment:

Drug: Pemetrexed/Platinum