Extensive-stage Small Cell Lung CancerNCT04663438
Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC
An observational study of Extensive-stage Small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The study is a prospective,multi-center,single arm,real world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer,and also to explore potential biomarkers for Immune-related Adverse Events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Chemotherapy Drugs, Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to 30 May 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 to 80 years
- All sexes
- Adult, Older adult
Study population: This study is a prospective, multi-center, single-arm, real-world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer, and also to explore potential biomarkers for Immune-related Adverse Events. People with ES-SCLC will be included in the study according to the eligibility criteria.
Who may be able to join
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
- No prior systemic treatment for ES-SCLC
- 18-80 years old, or more than 10 months of expected natural survival;
- Eastern Cooperative Oncology Group performance status of 0 or 1 or 2
- Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end organ function
- Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
- The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
Who cannot join
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose chemotherapy. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
- Patients or family members cannot understand the conditions and goals of this study.
- The subject has an estimated life expectancy of less than 10 months The subject is unable or unwilling to comply with the study requirements or follow-up schedule
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital，
Beijing, Beijing Municipality, 110000
About this study
Official title: First-line Atezolizumab Plus Chemotherapy in Patients With Extensive-stage Small-cell Lung Cancer:a Real World,Single Arm,Multicenter,Prospective Study in China
The study is a prospective,multi-center,single arm,real world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer,and also to explore potential biomarkers for Immune-related Adverse Events.
Read the detailed description
In 2018,the results of IMpower 133 were reported on WCLC.Meanwhile,the data was published in NEJM.Atezolizumab combined with carboplatin and etoposide for extensive stage small cell lung cancer was recommended as the first by NCCN guidelines quickly.
Atezolizumab plus chemotherapy was approved by NMPA on Feb 13,2020,making Atezolizumab for 1L ES-SCLC in China.
Real world study can reflect the efficacy and safety of treatment in clinical practice.Based on the research of public database,the prospective cohort study had been reported,but the study based on Chinese patients still left weak point.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Chemotherapy Drugs, Cancer
- Keywords
- 1L ES-SCLC
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy Drugs, CancerDrug
Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil
| Study group | Role | What they receive |
|---|---|---|
| Arm A | 200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w Receives: Drug: Chemotherapy Drugs, Cancer | |
| Arm B | 100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w Receives: Drug: Chemotherapy Drugs, Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Duration of overall survival
Measured: Baseline until death from any cause(up to approximately 23 months)
irAE
Percentage of participants with Immune-related
Measured: Baseline until up to 90 days after end of treatment(up to approximately 46 months) and related biomarkers
Secondary outcomes (4)
PFS
Duration of Progression-Free Survival as assessed by the Investigator using Recist v1.1
Measured: Baseline until PD or death,whichever occurs first(up to approximately 23months)]
Treatment related biomarkers
Biomarkers:CD 4+,CD28+,PD L1,TMB etc.
Measured: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Quality of Life (QL)
QL as assessed by using EORTC
Measured: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
) Score
QLQ C30 Score and EORTC QLQ Lung cancer module (LC13)Score
Measured: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start30 Jun 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, China-Japan Friendship Hospital, Beijing Chest Hospital, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Li Zhang, Peking Union Medical College Hospital
- Investigators
- Li Zhang, PhD, Principal investigator, Peking union medical college hospital,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663438
- Sponsor's protocol ID
- ZS-2407
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
PubMed 17008692
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Atezolizumab Plus Chemotherapy in Patients With Extensive-stage Small-cell Lung Cancer:a Real World,Single Arm,Multicenter,Prospective Study in China
- ClinicalTrials.gov ID
- NCT04663438
- Acronym / sponsor ID
- ZS-2407
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- 1L ES-SCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, China-Japan Friendship Hospital, Beijing Chest Hospital, Beijing Chao Yang Hospital
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 11 Dec 2020 (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 study is a prospective,multi-center,single arm,real world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer,and also to explore potential biomarkers for Immune-related Adverse Events.
Detailed description
In 2018,the results of IMpower 133 were reported on WCLC.Meanwhile,the data was published in NEJM.Atezolizumab combined with carboplatin and etoposide for extensive stage small cell lung cancer was recommended as the first by NCCN guidelines quickly.
Atezolizumab plus chemotherapy was approved by NMPA on Feb 13,2020,making Atezolizumab for 1L ES-SCLC in China.
Real world study can reflect the efficacy and safety of treatment in clinical practice.Based on the research of public database,the prospective cohort study had been reported,but the study based on Chinese patients still left weak point.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Drug: Chemotherapy Drugs, Cancer200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w |
| Arm B | – | Drug: Chemotherapy Drugs, Cancer100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective, multi-center, single-arm, real-world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer, and also to explore potential biomarkers for Immune-related Adverse Events. People with ES-SCLC will be included in the study according to the eligibility criteria.
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
- No prior systemic treatment for ES-SCLC
- 18-80 years old, or more than 10 months of expected natural survival;
- Eastern Cooperative Oncology Group performance status of 0 or 1 or 2
- Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end organ function
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose chemotherapy. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
- Patients or family members cannot understand the conditions and goals of this study.
- The subject has an estimated life expectancy of less than 10 months The subject is unable or unwilling to comply with the study requirements or follow-up schedule
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 |
|---|---|---|
| Chemotherapy Drugs, CancerOther chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil | Drug | Arm A, Arm B |
Primary outcome
OS
Time frame: Baseline until death from any cause(up to approximately 23 months)
Duration of overall survival
irAE
Time frame: Baseline until up to 90 days after end of treatment(up to approximately 46 months) and related biomarkers
Percentage of participants with Immune-related
4 secondary outcomes
PFS
Time frame: Baseline until PD or death,whichever occurs first(up to approximately 23months)]
Treatment related biomarkers
Time frame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Quality of Life (QL)
Time frame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
) Score
Time frame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Results publication: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Results publication: PubMed 17008692Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
- Individual participant dataSharing planned: Undecided
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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.
Li Zhang, PhD principal investigator
Peking union medical college hospital,China
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 Peking Union Medical College 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, PhD (16601139836, pumchzhangli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: Baseline until death from any cause(up to approximately 23 months)). 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?
On the ClinicalTrials.gov record for NCT04663438, which also lists 2 linked publications.
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 11 Dec 2020.