Efficacy Biomarker Investigation on Extensive Stage Small... | NCT05055947

Studies
Efficacy Biomarker Investigation on Extensive Stage Small Cell Lung Cancer

NCT05055947

Sponsor

Hunan Province Tumor Hospital

Status

Completed

Last Update Posted

Jan 25, 2022Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Extensive Stage Small Cell Lung Cancer

Interventions

First line EC/EP+Atezolizumab

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Sep 14, 2021Actual

First Submitted Date

Sep 15, 2021

First Submission Date that Met QC Criteria

Sep 15, 2021

First Posted Date

Sep 24, 2021Actual

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

Jan 22, 2022

Last Update Posted Date

Jan 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

The purpose of the trial is to find some biomarkers to predict the efficacy of Atezolizumab plus etoposide and platinum based chemotherapy as the first line treatment in extensive stage small cell lung cancer. Mainly observe the patient's progression free survival time after treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
First line EC/EP+Atezolizumab	Drug	Etoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	Progression free survival	April 2019- July 2021
OS	Overall survival	April 2019- July 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18， Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Exclusion Criteria:

- Patients with contraindication of chemotherapy Pregnant or breast feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Extensive Stage Small Cell Lung Cancer who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yongchang Zhang, MD	Hunan Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hunan Cancer Hospital		Changsha	Hunan	410013	China

Description

FFPE: RNA-seq, WES, and Multi-immunofluorescence based IHC, Spatial transcriptomics Plasma+PBMC: Cytokine/chemokines and TCR-seq Fecal microbiota: Metabolomics and Metagenomic sequencing Fresh tissue Fresh tissue: RNA-seq? TCR? WES? Metabolomics? Single Cell Sequence