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Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients

Clinical Trials to Evaluate the Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients With Non-small Cell Lung Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05450081
Enrollment
140
Registered
2022-07-08
Start date
2022-06-30
Completion date
2023-10-01
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

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.

Interventions

None listed

Sponsors

Hunan Province Tumor Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 1)≥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. * 2\) 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

Exclusion criteria

* 1\) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \>20%); * 2\) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs; * 3\) Maintenance treatment when the disease does not progress after other anti-tumor treatments.

Design outcomes

Primary

MeasureTime frameDescription
ConsistencyOctober 2022-December 2022he consistency of efficacy between specified kit and 22C3
ORROctober 2022-December 2022Objective response rate
PFSOctober 2022-December 2022Progression free survival time

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026