Recruiting

Observational Study

Sponsor:

US Oncology Research

Code:

NCT05885698

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This longitudinal study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment-naive non-small cell lung cancer, whether squamous or non-squamous.

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT05885698

Start date

Jan 30, 2023

Status verified date

May, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult subjects (18 years and older) with newly diagnosed early stage, locally advanced or metastatic non-small cell lung cancer
  • Must be eligible for systemic therapy based on the treating provider's assessment. If systemic therapy was recommended and documented by the treating provider but the patient declined, they can still be eligible for the study. Patients can be enrolled prior to start of treatment.
  • Subjects who developed locally advanced or metastatic disease after receiving adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of locally advanced or metastatic disease
  • Subjects must be enrolled within 30 days of initiation of systemic therapy
  • Signed informed consent

Exclusion Criteria:

  • Stage IA at the time of enrollment
  • Subjects with small cell lung cancer
  • Subjects with Unknown primary tumor origin

Study Design

Enrollment

7500 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-small Cell Lung Cancer

Primary outcome measure

  • Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death [ Time Frame: 5 years from date of enrollment into study ]
  • Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing [ Time Frame: 5 years from date of enrollment into study ]
  • For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing [ Time Frame: 5 years from date of enrollment into study ]

Central Contacts and Locations

Central contacts

Locations

Southern Cancer Center, PC

Recruiting

Daphne, Alabama, United States, 36526

Contacts

Principal Investigator:

Michael Meshad, MD

Cancer Care Centers of Brevard, Inc.

Recruiting

Palm Bay, Florida, United States, 32901

Contacts

Principal Investigator:

Venkat Pavan R. Kancharla, MD

Affiliated Oncologists, LLC

Recruiting

Chicago Ridge, Illinois, United States, 60415

Contacts

Principal Investigator:

Rami Y. Haddad, MD

New York Oncology Hematology, P.C.

Recruiting

Albany, New York, United States, 12208

Contacts

Principal Investigator:

Makenzi Evangelist, MD

Oncology Hematology Care Clinical Trials, LLC

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Principal Investigator:

Patrick J. Ward, MD

Willamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Principal Investigator:

James E. Butrynski, MD

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Recruiting

Blacksburg, Virginia, United States, 24060

Contacts

Principal Investigator:

Jerome H. Goldschmidt, Jr., MD

Virginia Oncology Associates

Recruiting

Newport News, Virginia, United States, 23606

Contacts

Principal Investigator:

John C. Paschold, MD

Northwest Cancer Specialists, P.C.

Recruiting

Vancouver, Washington, United States, 98684

Contacts

Principal Investigator:

Anthony Van Ho, MD

More Information

Sponsor

US Oncology Research

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Carcinoma
  • Non-Small-Cell Lung Carcinoma
  • Nonsmall Cell Lung Cancer
  • Lung Cancer
  • Squamous Non-small Cell Lung Cancer
  • Non-squamous Non-small Cell Lung Cancer
  • Biomarker Testing
  • Tumor Tissue Testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by US Oncology Research on 2026-05-18.