- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04324151
Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable NSCLC
September 17, 2024 updated by: Yongchang Zhang, Hunan Province Tumor Hospital
Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
This study aims to explore the efficacy and safety of Pembrolizumab Combined With Double Platinum-Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
Study Overview
Status
Recruiting
Conditions
Detailed Description
Inclusion criteria:
diagnosed with Non-small cell lung cancer EGFR and ALK and ROS1 negative Treatment naive Potentially Resectable identified by MDT
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nong Yang, MD
- Phone Number: +8613873123436 +8613055193557
- Email: yangnong0217@163.com
Study Contact Backup
- Name: Yongchang Zhang, MD
- Phone Number: 7+861383123436 +8613873123436
- Email: zhangyongchang@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- Yongchang Zhang
-
Contact:
- Yongchang Zhang, MD
- Phone Number: +8613873123436 +8613873123436
- Email: zhangyongchang@csu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
Description
Inclusion Criteria:
- ≥18,Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
- Potentially Resectable NSCLC
- Treatment Plan is Crizotinb or Standard Chemotherapy
Exclusion Criteria:
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFS
Time Frame: may 2020- may 2021 (1 year)
|
Progression free survival
|
may 2020- may 2021 (1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OS
Time Frame: may 2020- may 2021 (1 year)
|
Overall survival
|
may 2020- may 2021 (1 year)
|
|
ORR
Time Frame: may 2020- may 2021 (1 year)
|
To measure the patients's overall response rate
|
may 2020- may 2021 (1 year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: YONGCHANG ZHANG, Hunan Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 24, 2020
Primary Completion (Estimated)
December 24, 2024
Study Completion (Estimated)
March 24, 2025
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
March 25, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 17, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERSPECT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.