---
title: Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
nct_id: NCT04153097
overall_status: UNKNOWN
sponsor: First Affiliated Hospital of Zhejiang University
study_type: OBSERVATIONAL
primary_condition: Non-small Cell Lung Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04153097.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04153097"
ct_last_update_post_date: 2023-02-16
last_seen_at: "2026-05-12T06:06:59.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

**NCT ID:** [NCT04153097](https://clinicaltrials.gov/study/NCT04153097)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 500
- **Lead Sponsor:** First Affiliated Hospital of Zhejiang University
- **Conditions:** Non-small Cell Lung Cancer
- **Start Date:** 2020-07-30
- **Completion Date:** 2024-12
- **CT.gov Last Update:** 2023-02-16

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **pembrolizumab-treated advanced NSCLC** — Patients with advanced non-small cell lung cancer treated with pembrolizumab

## Primary Outcomes

- **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

## 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)_

## Locations (8)

- The First Affiliated Hospital of College of Medicine Zhejiang University, Hangzhou, Zhejiang, China — _RECRUITING_
- Second Affiliated Hospital, Zhejiang University of Medicine, Hangzhou, Zhejiang, China — _RECRUITING_
- the First Hospital of Jiaxing, Jiaxing, Zhejiang, China — _RECRUITING_
- Jinhua Guangfu Hospital, Jinhua, Zhejiang, China — _RECRUITING_
- Ningbo Medical Center Lihuili Eastern Hospital, Ningbo, Zhejiang, China — _RECRUITING_
- Quzhou People's Hospital, Quzhou, Zhejiang, China — _RECRUITING_
- The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China — _RECRUITING_
- The People's Hospital of Zhuji, Zhuji, Zhejiang, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the first affiliated hospital of college of medicine zhejiang university|hangzhou|zhejiang|china` — added _(2026-05-12)_
- `locations.second affiliated hospital, zhejiang university of medicine|hangzhou|zhejiang|china` — added _(2026-05-12)_
- `locations.the first hospital of jiaxing|jiaxing|zhejiang|china` — added _(2026-05-12)_
- `locations.jinhua guangfu hospital|jinhua|zhejiang|china` — added _(2026-05-12)_
- `locations.ningbo medical center lihuili eastern hospital|ningbo|zhejiang|china` — added _(2026-05-12)_
- `locations.quzhou people's hospital|quzhou|zhejiang|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of wenzhou medical university|wenzhou|zhejiang|china` — added _(2026-05-12)_
- `locations.the people's hospital of zhuji|zhuji|zhejiang|china` — added _(2026-05-12)_

---

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