Non-small Cell Lung CancerNCT04153097
Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
An observational study of Non-small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University at 8 sites in China.
Trial summary
This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 500 participants
- Where
- 8 sitesChina
- Study dates
- 30 Jul 2020to Dec 2024
- How long will I take part?
- 3 Years
- 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: Total 500 patients who receive pembrolizumab for advanced NSCLC will be enrolled. The patients should be registered consecutively in each site.
Who may be able to join
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC
- Patients who receive pembrolizumab for advanced NSCLC.
- Patients who provided written informed consent.
Who cannot join
- 1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Jianying Zhou, MD, 13505719970, drzjy@163.com
Jianya Zhou, MD, 13858123060, zhoujianya@hotmail.com
- Recruiting
Second Affiliated Hospital, Zhejiang University of Medicine
Hangzhou, Zhejiang, 310009
Liren Ding, MD, Lirending@zju.edu.cn
- Recruiting
the First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001
Xiaodong Lv, MD, 287473706@qq.com
- Recruiting
Jinhua Guangfu Hospital
Jinhua, Zhejiang, 321000
Xiaoyu Wu, MD, 229901505@qq.com
- Recruiting
Ningbo Medical Center Lihuili Eastern Hospital
Ningbo, Zhejiang, 315040
Yaodong Tang, MD
- Recruiting
Quzhou People's Hospital
Quzhou, Zhejiang, 324000
Zhiqiang Han, MD, hzq_qz@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yuping Li, MD, wzliyp@163.com
- Recruiting
The People's Hospital of Zhuji
Zhuji, Zhejiang, 310020
Peifeng Chen, MD, chenpeifeng2266@sina.com
About this study
This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.
Read the detailed description
Pembrolizumab is a humanized antibody used in cancer immunotherapy.The NMPA(China) approved pembrolizumab for first-line treatment of certain patients with advanced NSCLC.
This is a multi-center non-interventional study, advanced NSCLC patients who treated with pembrolizumab and provide written informed consent will be included. The main objective of this study is to evaluate pembrolizumab efficacy and safety in the clinical practice and explore the prognosis-relevant factors of advanced NSCLC.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pembrolizumab-treated advanced NSCLC | Patients with advanced non-small cell lung cancer treated with pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Overall survival (OS) since start of pembrolizumab
OS was defined as the length of time from the administration of the first-dose until death from any cause.
Measured: 3 years
Objective Response Rate (ORR) since start of pembrolizumab
ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to irRECIST.
Measured: 6 months
Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab
Drug related AEs were evaluated using NCI-CTCAE v5.0
Measured: up to 3 months after the last dose
Secondary outcomes (2)
Median Progression Free Survival (PFS) since start of pembrolizumab
PFS is defined as the time from the start of first-dose to first progression disease (PD) or death, whichever is earlier.
Measured: 12 months
Median Time To Treatment failure (TTF) since start of pembrolizumab
TTF is defined as the time from the start of first-dose to discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start30 Jul 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianying Jianying, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153097
- Sponsor's protocol ID
- ZYHX-001
- Status last verified
- Aug 2022
- First submitted
- 4 Nov 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share date of the trial
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
- ClinicalTrials.gov ID
- NCT04153097
- Acronym / sponsor ID
- ZYHX-001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Nov 2019 (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 observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.
Detailed description
Pembrolizumab is a humanized antibody used in cancer immunotherapy.The NMPA(China) approved pembrolizumab for first-line treatment of certain patients with advanced NSCLC.
This is a multi-center non-interventional study, advanced NSCLC patients who treated with pembrolizumab and provide written informed consent will be included. The main objective of this study is to evaluate pembrolizumab efficacy and safety in the clinical practice and explore the prognosis-relevant factors of advanced NSCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pembrolizumab-treated advanced NSCLC | – | –Patients with advanced non-small cell lung cancer treated with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total 500 patients who receive pembrolizumab for advanced NSCLC will be enrolled. The patients should be registered consecutively in each site.
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC
- Patients who receive pembrolizumab for advanced NSCLC.
- Patients who provided written informed consent.
Key exclusion criteria (1 listed)
- 1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median Overall survival (OS) since start of pembrolizumab
Time frame: 3 years
OS was defined as the length of time from the administration of the first-dose until death from any cause.
Objective Response Rate (ORR) since start of pembrolizumab
Time frame: 6 months
ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to irRECIST.
Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab
Time frame: up to 3 months after the last dose
Drug related AEs were evaluated using NCI-CTCAE v5.0
2 secondary outcomes
Median Progression Free Survival (PFS) since start of pembrolizumab
Time frame: 12 months
Median Time To Treatment failure (TTF) since start of pembrolizumab
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No. No plan to share date of the trial
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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.
Jianying Jianying, MD principal investigator
First Affiliated Hospital of Zhejiang University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University at 8 sites 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 3 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Jianying Zhou, MD (13505719970, drzjy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Overall survival (OS) since start of pembrolizumab (time frame: 3 years). The study lists 3 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 16 Feb 2023.