Clinical trial · Interventional
Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection
Phase ⅡTrial of S1 Capsule Plus Cisplatin Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage Ⅱ-ⅢA Non-small Cell Lung Cancer (NSCLC) After Complete Resection
NCT02223611CI-TRIAL-00015443S1VSNPunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Stage Ⅱ | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Stage ⅢA | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S1 capsule | Drug | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S1 capsule plus Cisplatin
- 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
- interventionNames
- Drug: S1 capsule
- type
- ACTIVE_COMPARATOR
- label
- Vinorelbine plus Cisplatin
- description
- Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1. 3 weeks/4cycles
- interventionNames
- Drug: Vinorelbine
Primary outcomes (1)
- measure
- Disease free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.