Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

NCT ID: NCT06317558

Last Updated: 2024-07-03

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

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2034-12-31

Brief Summary

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The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are:

* What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?
* How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.

Detailed Description

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The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:

* What is the optimal strategy for utilizing immune checkpoint inhibitors as neoadjuvant therapy?
* How can we identify specific patient subgroups that derive the greatest benefit from neoadjuvant immunotherapy? Participants will undergo neoadjuvant immunotherapy, and the study will meticulously analyze real-world data to provide insights into these pivotal questions, contributing to the refinement of treatment strategies and patient care in NSCLC management.

Conditions

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NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neoadjuvant immunotherapy

Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.

Neoadjuvant immunotherapy

Intervention Type DRUG

Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.

Other neoadjuvant treatment

Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.

Other drugs for neoadjuvant treatment

Intervention Type DRUG

Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.

Interventions

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Neoadjuvant immunotherapy

Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.

Intervention Type DRUG

Other drugs for neoadjuvant treatment

Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.

Intervention Type DRUG

Other Intervention Names

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Immune checkpoint inhibitors Other drugs

Eligibility Criteria

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Inclusion Criteria

1. Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
2. Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
3. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
4. Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
5. At least one measurable lesion (RECIST v1.1).

Exclusion Criteria

1. Patients included in unblinded clinical trials or anti-tumor drug intervention.
2. Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shugeng Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Shugeng Gao

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shugeng Gao, MD

Role: CONTACT

8610-87788177

Facility Contacts

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Shugeng Gao, MD

Role: primary

010-87788177

Other Identifiers

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22/492-3694

Identifier Type: -

Identifier Source: org_study_id

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