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

NCT02631460 | Unknown Phase 2 DMC

• 1 other identifier: 5010-2015023
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

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）

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  3 years

Secondary Outcomes (4)

• 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

Study Arms (2)

S1 and Carboplatin

EXPERIMENTAL

S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1

Drug: S1 80-120 mg/d; Drug: carboplatin AUC=5

pemetrexed and Carboplatin

ACTIVE COMPARATOR

pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed

Drug: pemetrexed 500 mg/m2; Drug: carboplatin AUC=5

Interventions

S1 80-120 mg/d DRUG

d1, every 3 weeks

S1 and Carboplatin

pemetrexed 500 mg/m2 DRUG

d1, every 3 weeks

pemetrexed and Carboplatin

carboplatin AUC=5 DRUG

d1, every 3 weeks

S1 and Carboplatin; pemetrexed and Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \<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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

S 1 (combination); Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Yan Huang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, MD

CONTACT

zhangli@sysucc.org.cn

Yan Huang, MD

CONTACT

huangyan@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2019
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CN (1)