Predictive Assay for Decision Making in Adjuvant Therapy

Carcinoma, Non-Small-Cell Lung Clinical Trial

— PADMA  

Official title:

Predictive Assay for Decision Making in Adjuvant Therapy (PADMA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05032352
• Other study ID #: PADMA Trial
• Status: Terminated
• Start date: January 28, 2022
• Est. completion date: October 28, 2022

Study information

• Verified date: September 2021
• Source: OncoCyte
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Adjuvant
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.

Other:
• Observation
All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
OncoCyte	ClinLogix. LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Os — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Analyses	To evaluate predictive value of DetermaRx in driver positive NSCLC patients receiving chemotherapy, targeted therapy or both.; To evaluate predictive value of DetermaRx early NSCLC patients receiving chemotherapy + immunotherapy or other combination adjuvant therapies; To evaluate predictive value of other histological features on pathology in association with DetermaRx as well as additional biomarkers (i.e., KRAS, TP53, STK11, PD-L1 expression, etc.) if performed by physician in combination with DetermaRx results and related outcomes	30-36 months
Primary	Free Survival (DFS)	To compare Disease Free Survival (DFS) in patients with resected, stage I or IIA non-squamous NSCLC found to be at HIGH/INTERMEDIATE Risk by DetermaRX choosing to undergo adjuvant therapy using a platinum-based doublet or other adjuvant therapy versus observation.	30-36 months
Secondary	Secondary Objectives	To evaluate use patterns of DetermaRx in guiding use of adjuvant platinum-based chemotherapy across early-stage resected lung cancer; To evaluate DFS in DetermaRx LOW risk patients who are put on observation alone; To evaluate whether use of DetermaRx HIGH/INTERMEDIATE vs. LOW to guide adjuvant platinum-based therapy results in improved OS in patients; To evaluate if EGFR mutational status impacts use of adjuvant platinum-based therapy in DetermaRx HIGH/INTERMEDIATE vs. LOW patients	30-36 months