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Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (VIGOR)

Primary Purpose

NSCLC

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aliya Pulsed Electric Fields (PEF) ablation

Nivolumab plus Platinum Doublet Chemotherapy

Standard of care neoadjuvant therapy

Surgical Resection

About this trial

This is an interventional treatment trial for NSCLC focused on measuring Lung Neoplasms, Thoracic Neoplasms, Lung Diseases, Antineoplastic Agents, Immunologic Factors, Immune Checkpoint Inhibitors, Nivolumab, Gemcitabine, Cisplatin, Docitaxel, Pemetrexed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is 18 years of age or older
Radiographic findings consistent with a lesion with high pre-procedure probability of malignancy as determined by the investigator to be NSCLC 8th Ed. stage IIB- IIIA cancer or biopsy-confirmed NSCLC 8th Ed. stage IIB-IIIA and lesion size ≤ 5 cm in greatest dimension
Lesion is targetable for biopsy and PEF delivery per investigator opinion
Patient deemed able to complete neoadjuvant therapy according to their EGFR/ALK mutation status and specific histology (if clinically appropriate) and per the manufacturer's systemic therapy labeling
Patient has been deemed a potential candidate for definitive lung tissue resection by a qualified study investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Patient is able to adhere to protocol requirements
Patient is able to tolerate general anesthesia
Patient is cleared to undergo paralytic anesthesia
Patient has provided informed consent

Exclusion Criteria:

Presence of advanced, inoperable, or metastatic disease
Radiographically suspicious findings for stage IIIA patients indicating a single mediastinal lymph node > 3 cm or multiple mediastinal lymph nodes and, therefore, potentially inoperable
Patient has recurrent NSCLC or has previously been treated for NSCLC
Patient has received chemotherapy or any other cancer therapy in 2 years prior to PEF ablation
Prior treatment with any drug that targets T cell co-regulatory pathways (such as checkpoint inhibitors) in 2 years prior to PEF ablation
Patient requires or is likely to require a pneumonectomy
Patient has received any vaccine against infectious diseases (e.g., influenza, COVID-19, varicella, etc.) within 30 days of PEF procedure Patient is unable or unwilling to complete all required screening and/or follow-up assessments
Patient is currently enrolled in another interventional clinical trial or is receiving treatment with an investigational medication or medical device that conflicts with the study protocol

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

Mayo Clinic RochesterRecruiting
University of PennsylvaniaRecruiting
Temple UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aliya PEF ablation

Arm Description

Pulsed electric field treatment using the Aliya System

Outcomes

Primary Outcome Measures

Pathologic response

Pathologic response (percentage of residual viable tumor cells) of the resected lesion ablated with PEF and in resected lymph nodes in patients who received standard of care neoadjuvant nivolumab plus chemotherapy prior to resection.

Secondary Outcome Measures

Rate of R0 resection

R0 - no cancer cells seen microscopically at the primary tumor site

Full Information

NCT ID

NCT05583188

First Posted

October 13, 2022

Last Updated

April 28, 2023

Sponsor

Galvanize Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05583188

Brief Title

Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC

Acronym

VIGOR

Official Title

Neoadjuvant Soft Tissue Ablation Utilizing Aliya™ Pulsed Electric Fields With Systemic Therapy in Early-Stage Resectable Non-Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galvanize Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A prospective, single-arm, non-randomized, multi-center, open-label study following patients with resectable stage IIB to IIIA non-small cell lung cancer after Pulsed Electric Fields (PEF) ablation who may be candidates for standard of care neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.

Detailed Description

This study is designed to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with resectable stage IIB to IIIA NSCLC who may be candidates for standard of care neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy. The study will enroll adult patients with suspected or confirmed 8th ed. Stage IIb-IIIA non-small cell lung cancer (NSCLC) who are surgical candidates and have not yet received treatment for NSCLC. PEF ablation may be performed in conjunction with the clinically appropriate approach to collect standard of care biopsy samples to confirm disease progression. PEF ablation will be delivered via percutaneous approach utilizing the Galvanize Aliya™ System and the percutaneous Aliya Ablation Device. SOC neoadjuvant systemic treatment will be delivered following PEF ablation delivery according to EGFR and ALK mutation status, tumor histology, and surgical candidacy. Patients will undergo surgical resection per standard of care. The study will consent up to 15 adult patients in order to accrue at least five (5) patients who have completed surgical resection after receiving neoadjuvant therapy with nivolumab plus chemotherapy following PEF ablation. The remaining patients (up to 10) not eligible for neoadjuvant nivolumab plus chemotherapy will receive either SOC systemic therapy post-PEF ablation followed by resection or, if not eligible for systemic therapy, will receive definitive surgery without neoadjuvant therapy as per institutional SOC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC

Keywords

Lung Neoplasms, Thoracic Neoplasms, Lung Diseases, Antineoplastic Agents, Immunologic Factors, Immune Checkpoint Inhibitors, Nivolumab, Gemcitabine, Cisplatin, Docitaxel, Pemetrexed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aliya PEF ablation

Arm Type

Experimental

Arm Description

Pulsed electric field treatment using the Aliya System

Intervention Type

Device

Intervention Name(s)

Aliya Pulsed Electric Fields (PEF) ablation

Intervention Description

Patients will undergo PEF ablation

Intervention Type

Drug

Intervention Name(s)

Nivolumab plus Platinum Doublet Chemotherapy

Other Intervention Name(s)

Carboplatinum, Cipsplatin, Pemetrexed, Gemcitabine, Paclitaxel

Intervention Description

If EGFR/ALK mutation negative, patients will receive standard of care dosing of three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) post-PEF ablation followed by resection.

Intervention Type

Drug

Intervention Name(s)

Standard of care neoadjuvant therapy

Other Intervention Name(s)

Carboplatinum, Cipsplatin, Pemetrexed, Gemcitabine, Paclitaxel, Vinorelbine

Intervention Description

Patients not eligible for neoadjuvant nivolumab plus chemotherapy will receive standard of care systemic therapy post-PEF ablation followed by resection.

Intervention Type

Other

Intervention Name(s)

Surgical Resection

Intervention Description

Patients not eligible for systemic therapy will receive definitive surgery without neoadjuvant therapy as per institutional standard of care post-PEF ablation.

Primary Outcome Measure Information:

Title

Pathologic response

Description

Time Frame

Surgical resection

Secondary Outcome Measure Information:

Title

Rate of R0 resection

Description

R0 - no cancer cells seen microscopically at the primary tumor site

Time Frame

Surgical resection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is 18 years of age or older Radiographic findings consistent with a lesion with high pre-procedure probability of malignancy as determined by the investigator to be NSCLC 8th Ed. stage IIB- IIIA cancer or biopsy-confirmed NSCLC 8th Ed. stage IIB-IIIA and lesion size ≤ 5 cm in greatest dimension Lesion is targetable for biopsy and PEF delivery per investigator opinion Patient deemed able to complete neoadjuvant therapy according to their EGFR/ALK mutation status and specific histology (if clinically appropriate) and per the manufacturer's systemic therapy labeling Patient has been deemed a potential candidate for definitive lung tissue resection by a qualified study investigator Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Patient is able to adhere to protocol requirements Patient is able to tolerate general anesthesia Patient is cleared to undergo paralytic anesthesia Patient has provided informed consent Exclusion Criteria: Presence of advanced, inoperable, or metastatic disease Radiographically suspicious findings for stage IIIA patients indicating a single mediastinal lymph node > 3 cm or multiple mediastinal lymph nodes and, therefore, potentially inoperable Patient has recurrent NSCLC or has previously been treated for NSCLC Patient has received chemotherapy or any other cancer therapy in 2 years prior to PEF ablation Prior treatment with any drug that targets T cell co-regulatory pathways (such as checkpoint inhibitors) in 2 years prior to PEF ablation Patient requires or is likely to require a pneumonectomy Patient has received any vaccine against infectious diseases (e.g., influenza, COVID-19, varicella, etc.) within 30 days of PEF procedure Patient is unable or unwilling to complete all required screening and/or follow-up assessments Patient is currently enrolled in another interventional clinical trial or is receiving treatment with an investigational medication or medical device that conflicts with the study protocol Other protocol defined inclusion/exclusion criteria apply

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Partha Seshaiah, PhD

Phone

650-268-4252

pseshaiah@galvanizetx.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Krimsky, MD

Organizational Affiliation

Chief Medical Officer

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karlyn Pierson

pierson.karlyn@mayo.edu

First Name & Middle Initial & Last Name & Degree

Janani Reisenauer, MD

First Name & Middle Initial & Last Name & Degree

Matthew Callstrom, MD, PhD

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle Andronov

Phone

215-349-8726

Michelle.Andronov@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

David DiBardino, MD

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19122

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerard Criner, MD

Phone

215-707-1359

breathe@tuhs.temple.edu

First Name & Middle Initial & Last Name & Degree

Gerard Criner, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan of data sharing

Citations:

PubMed Identifier

35403841

Citation

Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.

Results Reference

background

PubMed Identifier

24384493

Citation

Hellmann MD, Chaft JE, William WN Jr, Rusch V, Pisters KM, Kalhor N, Pataer A, Travis WD, Swisher SG, Kris MG; University of Texas MD Anderson Lung Cancer Collaborative Group. Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint. Lancet Oncol. 2014 Jan;15(1):e42-50. doi: 10.1016/S1470-2045(13)70334-6.

Results Reference

background

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT02998528

Description

CheckMate 816 Clinical Study

Learn more about this trial

Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC

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