AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPADMANCT05032352

Predictive Assay for Decision Making in Adjuvant Therapy

An observational study of Carcinoma, Non-Small-Cell Lung, run by Insight Molecular Diagnostics at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Adjuvant and Observation
How many people
55 participants
Where
18 sitesUnited States
Study dates
28 Jan 2022to 28 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.)

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Piedmont Cancer Center

    Atlanta, Georgia, 30309

  • Our Lady of the Lake Regional Medical Center

    Baton Rouge, Louisiana, 70808

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Northshore University Healthsystem

    Evanston, Illinois, 60201

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Mary Washington Hospital

    Fredericksburg, Virginia, 22401

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • West Virginia University Medicine

    Morgantown, West Virginia, 26506

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Texas Oncology-San Antonio Medical Center

    San Antonio, Texas, 78240

  • Methodist Healthcare

    San Antonio, Texas, 78249

  • Peace Health

    Vancouver, Washington, 98683

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Texas Oncology-Wichita Falls Cancer Center

    Wichita Falls, Texas, 76310

Other trials in United States

About this study

Official title: Predictive Assay for Decision Making in Adjuvant Therapy (PADMA)

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

Read the 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

Being tested
Adjuvant, Observation
Keywords
Non-squamous Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdjuvantDrug

    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.

  • ObservationOther

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

Study groups in NCT05032352
Study groupRoleWhat they receive
Treatment ArmTreatment 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)
Receives: Drug: Adjuvant; Other: Observation
Observation onlyAll patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first.
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30-36 months

Secondary outcomes (1)

  1. Secondary Objectives

    1. To evaluate use patterns of DetermaRx in guiding use of adjuvant platinum-based chemotherapy across early-stage resected lung cancer
    2. To evaluate DFS in DetermaRx LOW risk patients who are put on observation alone
    3. To evaluate whether use of DetermaRx HIGH/INTERMEDIATE vs. LOW to guide adjuvant platinum-based therapy results in improved OS in patients
    4. To evaluate if EGFR mutational status impacts use of adjuvant platinum-based therapy in DetermaRx HIGH/INTERMEDIATE vs. LOW patients

    Measured: 30-36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start28 Jan 2022
  3. Primary completion28 Oct 2022
  4. Study completion28 Oct 2022

Why it stopped: Non-safety related, reallocation of resources

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032352
Sponsor's protocol ID
PADMA Trial
Acronym
PADMA
Status last verified
Sep 2021
First submitted
26 Aug 2021
Last updated
14 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not determined yet

Publications

  • 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.

    PubMed 32955177

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Non-Small-Cell Lung, run by Insight Molecular Diagnostics at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Non-safety related, reallocation of resources). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Free Survival (DFS) (time frame: 30-36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05032352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in