NCT04322591

Brief Summary

This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

4.8 years

First QC Date

March 24, 2020

Last Update Submit

December 25, 2023

Conditions

Non-small Cell Lung Cancer

Keywords

PD-L1 ;RET Fusion Lung Cancer Patients

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival time

    may 2020- may 2021 (1 year)

Secondary Outcomes (2)

  • ORR

    may 2020- may 2021 (1 year)

  • OS

    may 2020- may 2021 (1 year)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

RET Fusion Positive Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS

You may qualify if:

  • ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
  • RET Fusion Positive
  • First Diagnosis and Treatment
  • Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody

You may not qualify if:

  • \- Patients received antitumor treatment before
  • Patients with contraindication of chemotherapy
  • Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample and plasma DNA

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yongchang Zhang, MD

    Hunan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613055193557yangnong0217@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

March 24, 2020

Primary Completion

December 24, 2024

Study Completion

March 24, 2025

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

CN(1)