Predictive Assay for Decision Making in Adjuvant Therapy

Stopped early

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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

Key facts

Study ID

NCT05032352

Run by

Insight Molecular Diagnostics

People needed

55

Starts

2022-01-28

Expected to finish

2022-10-28

Last updated by the study team

2022-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent using the appropriate approved Institutional Review Board (IRB) approved consent.
• Age ≥ 18 years
• Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy and likely compliance with follow-up for anticipated length of study (18 months from randomization).
• Adequate tissue sample, paraffin block with tumor occupying at least 25% of the tissue surface area, for the 14 -gene prognostic assay, DetermaRx
• Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC per 8th edition, TNM staging system. Mixed histology cases (adenosquamous), large cell, or adenocarcinoma not otherwise classified (NOS) are eligible for the study, as long as they contain at least some component that is neither squamous cell, nor small cell nor neuroendocrine. Eligible resections include lobectomy, bilobectomy, segmentectomy, sleeve lobectomy and pneumonectomy. Resections via segmentectomy or wedge resection should be limited to patients with a peripheral tumor 2 cm or less with wide margins (> 2 cm or > the size of the nodule). Complete resection must also be accompanied, at a minimum, by intra-operative systematic mediastinal lymph node sampling. Systematic sampling is defined as removal of at least one representative lymph node each from levels 4 and 7 for a right-sided cancer and from levels 5 and/or 6 and 7 for left-sided cancers. Complete mediastinal lymph node dissection (MLND), however, is preferred, and is defined as resection of all lymph nodes at those same levels for right- and left-sided cancers.
• ECOG performance status 0-1
• No prior anti-neoplastic (NSCLC ) treatment in the pre-operative or post-operative setting (including chemotherapy, targeted therapy, immunotherapy, radiation, ablative procedures, etc.)

You may not qualify if…

• Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histological subtypes.
• Evidence of greater than stage IIA pathologic staging
• Evidence of incomplete resection (R1)
• Prior systemic chemotherapy or anti-cancer agent for NSCLC
• Any pre- or post-operative radiotherapy for the index tumor being considered for enrollment

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Jupiter Medical Center — Jupiter, Florida, United States
• Piedmont Cancer Center — Atlanta, Georgia, United States
• Northshore University Healthsystem — Evanston, Illinois, United States
• The University of Kansas Hospital — Kansas City, Kansas, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Texas Oncology-San Antonio Medical Center — San Antonio, Texas, United States
• Methodist Healthcare — San Antonio, Texas, United States
• Texas Oncology-Wichita Falls Cancer Center — Wichita Falls, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Mary Washington Hospital — Fredericksburg, Virginia, United States
• Providence Regional Medical Center Everett — Everett, Washington, United States
• Peace Health — Vancouver, Washington, United States
• West Virginia University Medicine — Morgantown, West Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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