Uncommon Pathological Types of Lung CancerEsportaNCT05023837
Efficacy and Safety of Immunotherapy in Non-small Cell Lung Cancer With Uncommon Histological Type
An observational study of Uncommon Pathological Types of Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This study was designed to explore the efficacy and safety of immune checkpoint inhibitor for advanced uncommon pathological types of lung cancer whether or not it is accompanied by a driver mutationin the real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncommon Pathological Types of Lung Cancer
- What is being tested?
- Pembrolizumab 100 MG Injection
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2018to 3 Aug 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: Advanced uncommon pathological types of lung cancer by histopathology
Who may be able to join
- 18，Advanced uncommon pathological types of lung cancer by histopathology whether or not it is accompanied by a driver mutation Treatment Plan is pembrolizumab 200mg iv q21d
Who cannot join
- Patients received antitumor treatment before Patients with contraindication of chemotherapy Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Immunotherapy in Uncommon Pathological Types of Lung Cancer
This study was designed to explore the efficacy and safety of immune checkpoint inhibitor for advanced uncommon pathological types of lung cancer whether or not it is accompanied by a driver mutationin the real world. Through retrospective collection of clinical data of patients with uncommon pathological types of lung cancer.The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two.
Read the detailed description
This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced uncommon pathological types of lung cancer and observe the efficacy and safety of immune checkpoint inhibitor regimen in the real world. The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two. Statistical analysis is used to compare the differences between the two treatments, so that patients can better choose treatment strategies.
- Being tested
- Pembrolizumab 100 MG Injection
- Keywords
- Uncommon pathological types of lung cancer, Immune checkpoint inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab 100 MG InjectionDrug
Pembrolizumab iv 200mg q21d
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression survival time
Measured: may 2019- may 2021
Secondary outcomes (1)
OS
over survival time
Measured: may 2019- may 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start2 Mar 2018
- Primary completion2 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncommon Pathological Types of 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
- 40 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
- NCT05023837
- Sponsor's protocol ID
- Esporta
- Acronym
- Esporta
- Status last verified
- Jan 2022
- First submitted
- 21 Aug 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song L, Zhou F, Xu T, Zeng L, Xia Q, Wang Z, Deng L, Li Y, Qin H, Yan H, Huang Z, Mi J, Xu Q, Yang N, Zhou C, Zhang Y. Clinical activity of pembrolizumab with or without chemotherapy in advanced pulmonary large-cell and large-cell neuroendocrine carcinomas: a multicenter retrospective cohort study. BMC Cancer. 2023 May 16;23(1):443. doi: 10.1186/s12885-023-10952-w.
PubMed 37189075
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
- Evaluation of the Efficacy of Immunotherapy in Uncommon Pathological Types of Lung Cancer
- ClinicalTrials.gov ID
- NCT05023837
- Acronym / sponsor ID
- Esporta / Esporta
- Keywords
- Uncommon pathological types of lung cancer, Immune checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 27 Aug 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.
This study was designed to explore the efficacy and safety of immune checkpoint inhibitor for advanced uncommon pathological types of lung cancer whether or not it is accompanied by a driver mutationin the real world. Through retrospective collection of clinical data of patients with uncommon pathological types of lung cancer.The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two.
Detailed description
This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced uncommon pathological types of lung cancer and observe the efficacy and safety of immune checkpoint inhibitor regimen in the real world. The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two. Statistical analysis is used to compare the differences between the two treatments, so that patients can better choose treatment strategies.
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
- Advanced uncommon pathological types of lung cancer by histopathology
Key inclusion criteria (1 listed)
- 18，Advanced uncommon pathological types of lung cancer by histopathology whether or not it is accompanied by a driver mutation Treatment Plan is pembrolizumab 200mg iv q21d
Key exclusion criteria (1 listed)
- Patients received antitumor treatment before 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 |
|---|---|---|
| Pembrolizumab 100 MG InjectionPembrolizumab iv 200mg q21d | Drug | – |
Primary outcome
PFS
Time frame: may 2019- may 2021
progression survival time
1 secondary outcome
OS
Time frame: may 2019- may 2021
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.
- Derived from this study: PubMed 37189075Song L, Zhou F, Xu T, Zeng L, Xia Q, Wang Z, Deng L, Li Y, Qin H, Yan H, Huang Z, Mi J, Xu Q, Yang N, Zhou C, Zhang Y. Clinical activity of pembrolizumab with or without chemotherapy in advanced pulmonary large-cell and large-cell neuroendocrine carcinomas: a multicenter retrospective cohort study. BMC Cancer. 2023 May 16;23(1):443. doi: 10.1186/s12885-023-10952-w.
Related trials for Uncommon Pathological Types of Lung Cancer
RecruitingObservational study
Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)
Breast Cancer, Lung Cancer
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
RecruitingObservational study
Institutional Registry of Rare Diseases
Rare Diseases, Amyloidosis
RecruitingObservational study
Genomic Investigation of Unusual Responders
Cancer, Breast Cancer
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 Uncommon Pathological Types of 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: may 2019- may 2021). 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 NCT05023837, which also lists 1 linked publication.
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.