NCT04945200

Unknown

Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemot...

Second Affiliated Hospital, Zhejiang University, School of Medicine Source

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Other study identifiers

Sponsor study identifier

2020-1003

Study Type

observational

Estimated enrollment

50

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2021

Actual (reported)

Primary Completion

June 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

The primary object of this study is to determine tumor major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy and molecular biomarkers related to the clinical response.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 50 participants
Study completion date: December 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2021
Actual (reported)
First Submitted
June 17, 2021
Actual (reported)
First Posted
June 30, 2021
Actual (reported)
Primary Completion
June 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: June 30, 2021
Status Verified: March 2021
Last Update Submitted: June 21, 2021

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, neoadjuvant, biomarker

Outcome Measures

Primary Outcomes (1)

molecular biomarkers related to clinical response
molecular biomarkers related to tumor major pathological response (MPR) and pathologic complete response (pCR) in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy
change from baseline to postoperation, an average of 1 week

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

stage IB-IIIA NSCLC

You may qualify if:

Able to understand the nature of this trial and provide written informed consent.

Sponsors & Collaborators

Second Affiliated Hospital, Zhejiang University, School of Medicine
Otherlead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Pingli Wang, M.DCONTACT+86 135 1680 8409 pingliwang@zju.edu.cn

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Pingli Wang, M.D

CONTACT

+86 135 1680 8409 pingliwang@zju.edu.cn

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 30, 2021

Study Start

January 1, 2021

Actual (reported)

Primary Completion

June 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Terminated

NCT04379739

Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer

Phase 2Active Not Recruiting

NCT04762030

Neoadjuvant Durvalumab/Anlotinib /Chemotherapy Plus Curative Resection in Stage III Non-Small-Cell Lung Cancer : A Single-arm Phase II Study

Phase 2Unknown

NCT04762459

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

Phase 3Enrolling By Invitation

NCT04322617

Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer

Phase 2/3Recruiting

NCT05059951

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Recruiting

NCT04646837

Mechanism of Response to IMFINZI Neoadjuvant Therapy in Non-small Cell Lung Cancer Patients Based on Multiple-omics Models

Phase 1/2Unknown

years ≤ age ≤ 80 years

Histologically documented non-small cell lung cancer

NSCLC with resection option for potential cure.This may include clinical stage IB, II and IIIA.

Subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy according to disease evaluation.

Measurable disease by RECIST v1.1

Tumor tissue sample and/or alveolar lavage fluid must be available for biomarker evaluation before operation.

You may not qualify if:

Subjects are excluded if they are enrolled in any other interventional studies.
Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration.
Subjects are excluded if they have an active, known or suspected autoimmune disease requiring systemic treatment (e.g.corticosteroids or other immunosuppressive medications) in 2 years before the study drug administration. substitution therapy ( e.g. thyroxine, insulin) are permitted.
Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC.
History of allergy to study drug components
Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.
Any other conditions that, in the Investigator's opinion, unfit to attend this study.

Contact the study team to confirm eligibility.

Study Completion

December 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

June 30, 2021

Record last verified: 2021-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04945200
Data provider: ClinicalTrials.gov
Source updated: 2021-06-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:36 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations