Oral vinorelbine and cisplatin as first-line therapy for advanced squamous NSCLC patients: a prospective randomized international phase II study (NAVoTrial 03).

ABSTRACT:

Objective

The study investigated the efficacy and safety of oral vinorelbine-cisplatin (OV-CDDP) and gemcitabine-cisplatin (GEM-CDDP) in patients with squamous non-small cell lung cancer (sq-NSCLC).

Patients and methods

This was an open-label, prospective, multicenter, international phase II study that enrolled untreated patients with advanced sq-NSCLC. Patients were randomized to receive 3-week cycles of either 60-80 mg/m² OV days 1 and 8 in combination with 80 mg/m² CDDP day 1 (arm A) or 1250 mg/m² GEM days 1 and 8 in combination with 75 mg/m² CDDP day 1 (arm B). After four cycles, patients without disease progression continued maintenance dose of OV or GEM until progression or unacceptable toxicity. The primary objective was dis

SUBMITTER: Grossi F 

PROVIDER: S-EPMC8287271 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature