Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

NCT ID: NCT04153097

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-30

Study Completion Date

2024-12-31

Brief Summary

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This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.

Detailed Description

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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

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pembrolizumab-treated advanced NSCLC

Patients with advanced non-small cell lung cancer treated with pembrolizumab

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC
2. Patients who receive pembrolizumab for advanced NSCLC.
3. Patients who provided written informed consent.

Exclusion Criteria

1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianying Jianying, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

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The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Second Affiliated Hospital, Zhejiang University of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

the First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Site Status RECRUITING

Jinhua Guangfu Hospital

Jinhua, Zhejiang, China

Site Status RECRUITING

Ningbo Medical Center Lihuili Eastern Hospital

Ningbo, Zhejiang, China

Site Status RECRUITING

Quzhou People's Hospital

Quzhou, Zhejiang, China

Site Status RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

The People's Hospital of Zhuji

Zhuji, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianying Zhou, MD

Role: CONTACT

13505719970

Jianya Zhou, MD

Role: CONTACT

13858123060

Facility Contacts

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Jianying Zhou, MD

Role: primary

13505719970

Jianya Zhou, MD

Role: backup

13858123060

Liren Ding, MD

Role: primary

Xiaodong Lv, MD

Role: primary

Xiaoyu Wu, MD

Role: primary

Yaodong Tang, MD

Role: primary

Zhiqiang Han, MD

Role: primary

Yuping Li, MD

Role: primary

Peifeng Chen, MD

Role: primary

Other Identifiers

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ZYHX-001

Identifier Type: -

Identifier Source: org_study_id

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