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Predictive Assay for Decision Making in Adjuvant Therapy

NCT05032352 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2022-11-14

No results posted yet for this study

Summary

Prospective Registrational Trial to Define Real World Outcomes of Patients with Completely Resected Stage I or IIA (tumor \< or = 5cm, node negative) Non-squamous Non-Small Lung Cancer (NSCLC) Identified as High, Intermediate, or Low Risk by a 14-Gene Prognostic Assay DetermaRx being Considered for Adjuvant Platinum-based chemotherapy or other adjuvant therapy versus Observation

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Adjuvant

Adjuvant treatment with a standard NSCLC platin-based doublet, 4 cycle (21-day) regimen of the investigator's choice (Arm 1) or other adjuvant therapy (Arm 1a) which can include combination of chemotherapy and targeted therapy, immunotherapy or other.

OTHER

Observation

All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first.

Sponsors & Collaborators

  • ClinLogix. LLC

    collaborator INDUSTRY

  • Insight Molecular Diagnostics

    lead INDUSTRY

Principal Investigators

  • Corey Langer, MD

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-28
Primary Completion
2022-10-28
Completion
2022-10-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05032352 on ClinicalTrials.gov