Predictive Assay for Decision Making in Adjuvant Therapy

NCT05032352 | Terminated

• 1 other identifier: PADMA Trial
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 18

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Objectives

  30-36 months

Other Outcomes (1)

• Exploratory Analyses

  30-36 months

Study Arms (2)

Treatment Arm

Treatment Arm 1: 4 cycles of adjuvant treatment with a standard NSCLC cisplatin-based doublet regimen or carboplatin-based regimen of physician choice. Treatment 1A: other adjuvant therapy or combination of adjuvant therapies (targeted therapy, immunotherapy, or other)

Drug: Adjuvant; Other: Observation

Observation only

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

Other: Observation

Interventions

Adjuvant DRUG

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.

Treatment Arm

Observation OTHER

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

Observation only; Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Insight Molecular Diagnostics: lead
• ClinLogix. LLC: collaborator

Study Sites (18)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Piedmont Cancer Center

Atlanta, Georgia, 30309, United States

Location

Northshore University Healthsystem

Evanston, Illinois, 60201, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Oncology-San Antonio Medical Center

San Antonio, Texas, 78240, United States

Location

Methodist Healthcare

San Antonio, Texas, 78249, United States

Location

Texas Oncology-Wichita Falls Cancer Center

Wichita Falls, Texas, 76310, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Mary Washington Hospital

Fredericksburg, Virginia, 22401, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Peace Health

Vancouver, Washington, 98683, United States

Location

West Virginia University Medicine

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related 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. 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.

  PMID: 32955177 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Adjuvants, Pharmaceutic; Observation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Methods; Investigative Techniques

Study Officials

• Corey Langer, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: January 28, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: November 14, 2022

Record last verified: 2021-09

Locations

US (18)