Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Cisplatin; Gemcitabine; Pemetrexed

Criteria

Inclusion Criteria:

• Histologically confirmed nonsquamous NSCLC

• Stage IIIb, IV or recurrent NSCLC

• Age ≥ 18years

• ECOG performance status of 0 to 1

• Known TS immunohistochemical analysis data

• At least one measurable lesion by RECIST 1.1

• No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC

• Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery

• At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy

• Adequate renal function: estimated creatinine clearance ≥ 50mL/min

Exclusion Criteria:

• Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.

• Patients with post-obstructive pneumonia or uncontrolled serious infection