Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer; Efficacy
• Interventions: Drug: cisplatin, dexamethasone,vitamin B12, folic acid; Drug: cisplatin, gemcitabine

• Registration Number: NCT01194453
• Lead Sponsor: Sun Yat-sen University

Brief Summary

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-08-25
• Primary Completion: 2010-09
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-03
• Study Completion: 2012-08
• Status Verified: 2016-05
• Results First Submitted: 2016-05-10
• Results First Submitted QC: 2016-05-10
• Last Update Submitted: 2016-05-10
• Results First Posted: 2016-06-16
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

1. Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
2. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
3. with an Eastern CooperativeOncology Group performance status of 0 or 1,
4. At least 18 years of age
5. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
7. patients had fully recovered from its acute effects.

Exclusion Criteria

1. peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1
2. progressive brain metastases,
3. uncontrolled third-space fluid retention before study entry.
4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	cisplatin, dexamethasone,vitamin B12, folic acid	-
Group B	cisplatin, gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	36months

Secondary Outcome Measures

Name	Time	Method
Response Rate	6 weeks

Trial Locations

Locations (1)

Cancer Center of Sun Yat-Sen University (CCSU); 🇨🇳 Guangzhou, Guangdong, China