Clinical trial NCT05032352: Predictive Assay for Decision Making in Adjuvant Therapy
Official title: Predictive Assay for Decision Making in Adjuvant Therapy (PADMA)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-squamous Non-Small Cell Lung Cancer
Lead sponsor: OncoCyte
Sponsor class: INDUSTRY
Collaborators: name: ClinLogix. LLC
First posted: 2021-09-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-squamous NSCLC who have undergone complete resection (R0) of the primary tumor and who have been documented to have pathologically confirmed stage I or IIA disease

Brief 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 criteria: 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

Primary outcomes:
measure: Free Survival (DFS)
timeFrame: 30-36 months
Secondary outcomes:
measure: Secondary Objectives
timeFrame: 30-36 months
Other outcomes:
measure: Exploratory Analyses
timeFrame: 30-36 months
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington Medical Faculty Associates
state: District of Columbia
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Center
state: Georgia
city: Evanston
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Medical Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology-Wichita Falls Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Fredericksburg
country: United States
facility: Mary Washington Hospital
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Vancouver
country: United States
facility: Peace Health
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Medicine
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
name: Corey Langer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.