Predictive Assay for Decision Making in Adjuvant Therapy
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
Checked against the public recordLast updated Nov 14, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Insight Molecular Diagnostics
- Interventions being studied
- Drug: Adjuvant; Other: Observation
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Written informed consent using the appropriate approved Institutional Review Board (IRB) approved consent. 2. Age ≥ 18 years 3. 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). 4. Adequate tissue sample, paraffin block with tumor occupying at least 25% of the tissue surface area, for the 14 -gene prognostic assay, DetermaRx 5. 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. 6. ECOG performance status 0-1 7. No prior anti-neoplastic (NSCLC ) treatment in the pre-operative or post-operative setting (including chemotherapy, targeted therapy, immunotherapy, radiation, ablative procedures, etc.) Exclusion Criteria: 1. Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histological subtypes. 2. Evidence of greater than stage IIA pathologic staging 3. Evidence of incomplete resection (R1) 4. Prior systemic chemotherapy or anti-cancer agent for NSCLC 5. Any pre- or post-operative radiotherapy for the index tumor being considered for enrollment
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of Hope National Medical CenterDuarte, California
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- George Washington Medical Faculty AssociatesWashington D.C., District of Columbia
- Jupiter Medical CenterJupiter, Florida
- Piedmont Cancer CenterAtlanta, Georgia
- Northshore University HealthsystemEvanston, Illinois
- The University of Kansas HospitalKansas City, Kansas
- Our Lady of the Lake Regional Medical CenterBaton Rouge, Louisiana
- Penn Presbyterian Medical CenterPhiladelphia, Pennsylvania
- Texas Oncology-San Antonio Medical CenterSan Antonio, Texas
- Methodist HealthcareSan Antonio, Texas
- Texas Oncology-Wichita Falls Cancer CenterWichita Falls, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 14, 2022. Always confirm current availability with the study team.