Clinical trial · Interventional
Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced NSNSCLC
Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
NCT03700333CI-TRIAL-00035187unknownPhase 3ClinicalTrials.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 compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed therapy | Drug | — | UNRESOLVED |
| S-1 therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S-1 Group
- description
- Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1)
- interventionNames
- Drug: S-1 therapy
- type
- ACTIVE_COMPARATOR
- label
- Pemetrexed Group
- description
- Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed
- interventionNames
- Drug: Pemetrexed therapy
Primary outcomes (1)
- measure
- progress free survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent 2. Histological or cytological documented 3. NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.1. 4. Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD. 5. Candidates's expected survival time should be greater than or equal to 3 months with ECOG performance status 0-1, adequate haematological and Hepatic- renal function, and cardiac function. 6. At least one measurable tumor lesion (maximum diameter has to be greater than 10mm scan by CT or MRI) or malignant lymph node (15mm in short axis), and must not be accepted radiotherapy. 7. No any other following malignancy or any serious complication caused by metastatic encephaloma. 8. No any gastrointestinal diseases that could reduce the drug absorption. 9. Female: Candidates who have any chance to be pregnant must accept pregnancy tests 72 hours before therapy, and take medical allowed contraceptives during therapy or in 3 mouths after therapy. Pregnancy tests results must be negative.Lactation female are not included. 10. Male: Be sterilized or take contraceptives during therapy or in 3 mouths after therapy. Exclusion Criteria: 1. Any unstable systemic disease 2. Patients with exposure to any recent anticancer therapy outside of this trial. 3. Pregnant or breast-feeding women
References
Publications (3)
- RESULTShirasaka T. Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol. 2009 Jan;39(1):2-15. doi: 10.1093/jjco/hyn127. Epub 2008 Dec 3. PMID 19052037
- RESULTKubota K, Sakai H, Yamamoto N, Kunitoh H, Nakagawa K, Takeda K, Ichinose Y, Saijo N, Ariyoshi Y, Fukuoka M. A multi-institution phase I/II trial of triweekly regimen with S-1 plus cisplatin in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2010 May;5(5):702-6. doi: 10.1097/JTO.0b013e3181ce3e22. PMID 20150827
- RESULTLi XN, Qiu D, Pan X, Hou XX. Mutation of the epidermal growth factor receptor gene and its impact on the efficacy of gefitinib in advanced non-small cell lung cance. Int J Clin Exp Med. 2015 Apr 15;8(4):5397-405. eCollection 2015. PMID 26131116