drugset / Trial / NCT02631460

S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous NSCLC

NCT02631460 ↗

Phase 2 Unknown 470 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or S1(80-120 mg/d)combined with carboplatin area under the curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed or S1. The primary end point of this non-inferiority study was progression free survival(PFS)

Timeline

Start
2015-12
Primary completion
2018-09
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pemetrexed Small molecule 500 mg/m2 —
Subject S-1 Small molecule 80 mg —
Subject S-1 Small molecule 120 mg —
Background Carboplatin Small molecule 5 unknown —