NCT05055947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
Last Updated

January 25, 2022

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

September 15, 2021

Last Update Submit

January 22, 2022

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • PFS

    Progression free survival

    April 2019- July 2021

  • OS

    Overall survival

    April 2019- July 2021

Interventions

First line EC/EP+AtezolizumabDRUG

Etoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Patients with contraindication of chemotherapy Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

  • Yongchang Zhang, MD

    Hunan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HunanPTH

Study Record Dates

First Submitted

September 15, 2021

First Posted

September 24, 2021

Study Start

April 1, 2019

Primary Completion

July 1, 2021

Study Completion

September 14, 2021

Last Updated

January 25, 2022

Record last verified: 2019-04

Locations

CN(1)