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

NCT03700333 | Unknown Phase 3

• 1 other identifier: NHP-18-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; S-1; Pemetrexed; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• progress free survival

  From date of randomization until the date of first documented progression.

  1 year

Secondary Outcomes (3)

• overall survival

  3 mouths, 6 mouths, 9 mouths, 1 year

• objective response rate

  3 mouths, 6 mouths, 9 mouths, 1 year

• duration of response

  6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year

Study Arms (2)

S-1 Group

EXPERIMENTAL

Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1)

Drug: S-1 therapy

Pemetrexed Group

ACTIVE COMPARATOR

Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed

Drug: Pemetrexed therapy

Interventions

S-1 therapy DRUG

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).

S-1 Group

Pemetrexed therapy DRUG

accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(\>21 days).

Pemetrexed Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Histological or cytological documented
• NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.1.
• Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD.
• 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.
• 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.
• No any other following malignancy or any serious complication caused by metastatic encephaloma.
• No any gastrointestinal diseases that could reduce the drug absorption.
• 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.
• Male: Be sterilized or take contraceptives during therapy or in 3 mouths after therapy.

You may not qualify if:

• Any unstable systemic disease
• Patients with exposure to any recent anticancer therapy outside of this trial.
• Pregnant or breast-feeding women

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (3)

• 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.

  PMID: 19052037 RESULT

• 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 Oncol. 2010 May;5(5):702-6. doi: 10.1097/JTO.0b013e3181ce3e22.

  PMID: 20150827 RESULT

• 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.

  PMID: 26131116 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yongqian Shu, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

• Renhua Guo, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renhua Guo, MD

CONTACT

025-68136360; rhguo@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: October 9, 2018
• Study Start: October 20, 2018
• Primary Completion: October 20, 2019
• Study Completion: October 20, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-05