Extensive Stage Small Cell Lung CancerNCT05055999
Tumor Microenvironment Surveillance on Simultaneous Liver Metastases Extensive Stage Small Cell Lung Cancer
An observational study of Extensive Stage Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
The purpose of the trial is to detect tumor microenvironment on Extensive Stage Small Cell Lung Cancer with simultaneous liver metastases who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- First line EC/EP+Atezolizumab
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Extensive Stage Small Cell Lung Cancer who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy
Who may be able to join
- 18， Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy
Who cannot join
- Patients with contraindication of chemotherapy Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tumor Microenvironment Surveillance on Simultaneous Liver Metastases Extensive Stage Small Cell Lung Cancer Who Treated With Atezolizumab Plus Etoposide and Platinum Based Chemotherapy
The purpose of the trial is to detect tumor microenvironment on Extensive Stage Small Cell Lung Cancer with simultaneous liver metastases who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- First line EC/EP+Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First line EC/EP+AtezolizumabDrug
Etoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 day
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: April 2019- July 2021
OS
Overall survival
Measured: April 2019- July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Apr 2019
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055999
- Sponsor's protocol ID
- MATCH
- Status last verified
- Apr 2019
- First submitted
- 15 Sep 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Microenvironment Surveillance on Simultaneous Liver Metastases Extensive Stage Small Cell Lung Cancer Who Treated With Atezolizumab Plus Etoposide and Platinum Based Chemotherapy
- ClinicalTrials.gov ID
- NCT05055999
- Acronym / sponsor ID
- MATCH
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to detect tumor microenvironment on Extensive Stage Small Cell Lung Cancer with simultaneous liver metastases who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Extensive Stage Small Cell Lung Cancer who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy
Key inclusion criteria (1 listed)
- 18， Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy
Key exclusion criteria (1 listed)
- Patients with contraindication of chemotherapy Pregnant or breast feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First line EC/EP+AtezolizumabEtoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 day | Drug | – |
Primary outcome
PFS
Time frame: April 2019- July 2021
Progression free survival
OS
Time frame: April 2019- July 2021
Overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extensive Stage Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: April 2019- July 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.