S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR W... | NCT02631460

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

NCT02631460

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Dec 16, 2015Estimated

Enrollment

470Estimated

Phase

Phase 2

Conditions

NSCLC

Interventions

S1 80-120 mg/d
pemetrexed 500 mg/m2
carboplatin AUC=5

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Sep 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Dec 12, 2015

First Submission Date that Met QC Criteria

Dec 15, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2015

Last Update Posted Date

Dec 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

470Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
S1 80-120 mg/d	Drug	d1, every 3 weeks	S1 and Carboplatin
pemetrexed 500 mg/m2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall survival(OS)		4 years
Disease control rate(DCR)		3 years
Health-related quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li Zhang, MD	Contact			zhangli@sysucc.org.cn
Yan Huang, MD	Contact			huangyan@sysucc.org.cn

Overall Officials

Name	Affiliation	Role
Yan Huang, MD	Sun Yat-Sen University Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun yat-sen University Cancer Center	Recruiting	Guangzhou	Guangdong	510060	China

Intervention Browse Module

MeSH Terms

ID	Term
C079198	S 1 (combination)
D000068437	Pemetrexed

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574

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