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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03700333
• Other study ID #: NHP-18-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 20, 2018
• Est. completion date: October 20, 2019

Study information

• Verified date: May 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Renhua Guo, MD
• Phone: 025-68136360
• Email: rhguo[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

S-1 consists of Tegafur,Gimeracil and Oteracil Potassium. Tegafur is metabolize to Gimeracil，and slows down the metabolism of 5-FU in high DPD enzyme expression tumor cell, so that 5-FU could bring the antimetabolic fiction more efficiently. Plenty of studies support that S-1 shows a desirable effect on advanced non-squamous NSCLC, and S-1 is more convenient compare with Pemetrexed. The curative effect of Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC has been proved to be valid. The purpose of our study is to explore whether S-1 could replace Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 20, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• S-1 therapy
accept S-1(50mg, twice a day, morning and night, if<1.5m2; 75mg, twice a day, morning and night,if >1.5m2 )chemotherapy after finishing first-line therapy(>21 days).
• Pemetrexed therapy
accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(>21 days).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

References & Publications (3)

Kubota 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 On — View Citation

Li 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. — View Citation

Shirasaka 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progress free survival	From date of randomization until the date of first documented progression.	1 year
Secondary	overall survival	every subjects needs to be recorded the data of death.From date of randomization until the date of death from any cause.	3 mouths, 6 mouths, 9 mouths, 1 year
Secondary	objective response rate	ORR(objective response rate) is equal to the sum of cases of CR (complete response) and PR (partial response) divided by the total number of evaluable cases.From date of randomization until the date of first documented progression.	3 mouths, 6 mouths, 9 mouths, 1 year
Secondary	duration of response	From the date of first documented CR (complete response) or PR (partial response) until the date of first documented progression or recurrence.	6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year