NCT05450081

Brief Summary

Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

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

June 29, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

June 29, 2022

Last Update Submit

December 25, 2023

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • PFS

    Progression free survival time

    October 2022-December 2022

  • ORR

    Objective response rate

    October 2022-December 2022

  • Consistency

    he consistency of efficacy between specified kit and 22C3

    October 2022-December 2022

Eligibility Criteria

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

Patients with non-small cell lung cancer who have previously received single-agent K therapy

You may qualify if:

  • )≥18，advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.
  • \) Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case

You may not qualify if:

  • \) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \>20%);
  • \) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
  • \) Maintenance treatment when the disease does not progress after other anti-tumor treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

Location

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 8, 2022

Study Start

June 30, 2022

Primary Completion

March 31, 2023

Study Completion

October 1, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

CN(1)