S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous NSCLC

A Randomized Phase II Study of S1 Plus Carboplatin Followed by Maintenance S1versus Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous Non-Small-Cell Lung Cancer

This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed or S1. The primary end point of this non-inferiority study was progression free survival（PFS）

Study Overview

• Status: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: S1 80-120 mg/d; Drug: carboplatin AUC=5; Drug: pemetrexed 500 mg/m2

• Study Type: Interventional
• Enrollment (Anticipated): 470
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guang Zhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Yan Huang, MD; Email: huangyan@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Chemotherapy-naive patients with histologically or cytologically confirmed nonsquamous NSCLC, classified as stage IIIB not amenable to curative treatment or stage IV; EGFR wild type.
2. At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors
3. Eastern Cooperative Oncology Group performance status of 0 or 1
4. 18 <age<75 years
5. Patients had adequate bone marrow reserve and organ function.
6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment and patients had fully recovered from its acute effects
7. Written informed consent was obtained directly from every patient
8. Estimated life expectancy of at least 12 weeks.
9. Patient compliance and geographic proximity that allow adequate follow up.
10. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate during and for 3 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

1. Brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments);
2. Serious infections or other serious complications.
3. Uncontrolled third-space fluid retention before study entry. unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids
4. Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
5. Pregnant or breast feeding.
6. A distinct history of drug allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S1 and Carboplatin; S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1	Drug: S1 80-120 mg/d; d1, every 3 weeks; Drug: carboplatin AUC=5; d1, every 3 weeks
Active Comparator: pemetrexed and Carboplatin; pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed	Drug: carboplatin AUC=5; d1, every 3 weeks; Drug: pemetrexed 500 mg/m2; d1, every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival(PFS)	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease control rate(DCR)	3 years
Number of Participants with Adverse Events	3 years
Overall survival(OS)	4 years
Health-related quality of life	3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 12, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Carboplatin; Pemetrexed
• Other Study ID Numbers: 5010-2015023