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Predictive Assay for Decision Making in Adjuvant Therapy | Clinical Trials | Clareo Health

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Predictive Assay for Decision Making in Adjuvant Therapy

Predictive Assay for Decision Making in Adjuvant Therapy (PADMA)

NCT05032352•Insight Molecular Diagnostics

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

Detailed Description

This is a prospective, non-randomized, 2 arm, multi-center study in patients with histologically documented non-squamous NSCLC who have undergone complete resection (R0) of the primary tumor with pathologically stage I or IIA disease. Routine paraffin-embedded tumor specimens from completely resected (R0) stage I or IIA patients with non-squamous NSCLC will undergo testing with the DetermaRx 14-Gene Prognostic Assay and will be designated as HIGH, INTERMEDIATE or LOW risk by the assay. The physician and patient will determine the best treatment course and will be assigned to treatment arm based on decision of adjuvant therapy or observation: 1. 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. 2. Observation (Arm 2) All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first. All patients will be observed for disease free survival and overall survival to the end of study or death, whichever occurs first

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (18)

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

Key Dates

Start Date

January 28, 2022

Primary Completion Date

October 28, 2022

Completion Date

October 28, 2022

Last Updated

November 14, 2022

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Adjuvant

DRUG

Observation

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Predictive Assay for Decision Making in Adjuvant Therapy

Inclusion Criteria

Exclusion Criteria

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

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