S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous NSCLC
- Conditions
- NSCLC
- Interventions
- Registration Number
- NCT02631460
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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）
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 470
- 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.
- At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors
- Eastern Cooperative Oncology Group performance status of 0 or 1
- 18 <age<75 years
- Patients had adequate bone marrow reserve and organ function.
- 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
- Written informed consent was obtained directly from every patient
- Estimated life expectancy of at least 12 weeks.
- Patient compliance and geographic proximity that allow adequate follow up.
- 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.
- Brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments);
- Serious infections or other serious complications.
- 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
- 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.
- Pregnant or breast feeding.
- A distinct history of drug allergies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pemetrexed and Carboplatin pemetrexed 500 mg/m2 pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed pemetrexed and Carboplatin carboplatin AUC=5 pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed S1 and Carboplatin carboplatin AUC=5 S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1 S1 and Carboplatin S1 80-120 mg/d S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1
- Primary Outcome Measures
Name Time Method Progression free survival(PFS) 3 years
- Secondary Outcome Measures
Name Time Method Overall survival(OS) 4 years Disease control rate(DCR) 3 years Health-related quality of life 3 years Number of Participants with Adverse Events 3 years
Trial Locations
- Locations (1)
Sun yat-sen University Cancer Center
🇨🇳Guang Zhou, Guangdong, China