Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection (S1VSNP)

Hebei Medical University

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer Stage Ⅱ; Non-small Cell Lung Cancer Stage ⅢA

Treatments: Drug: S1 capsule; Drug: Vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT02223611

HBMF9990

Details and patient eligibility

About

The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer patients after the complete resection.

Full description

Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC) accounts for more than 85% of all lung cancer cases.

For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. Various treatment regimens have been developed to improve survival.

S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an active single agent against NSCLC.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC)
• Must be able to receive the therapy of the study within four weeks after the completely resection

Exclusion criteria

• Systemic anticancer treatment
• local radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

S1 capsule plus Cisplatin

Experimental group

Description:

S1: 40mg, bid, when body surface area (BSA)\<1.25 m2, 50mg; bid when 1.25 m2≤BSA\<1.5 m2; 60mg, bid when 1.5 m2≤BSA 60mg from day 1 to 14. Cisplatin: 75 mg/m2 on day 1. 3 weeks/4cycles

Treatment:

Drug: S1 capsule

Vinorelbine plus Cisplatin

Active Comparator group

Description:

Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1. 3 weeks/4cycles

Treatment:

Drug: Vinorelbine