Overview

Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced NSNSCLC

Status:
Unknown status
Trial end date:
2019-10-20
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Treatments:
Pemetrexed
Criteria
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