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TerminatedNCT05583188VIGORUpdated Jul 19, 2024

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

A Phase 4 interventional study of Aliya Pulsed Electric Fields (PEF) ablation and Nivolumab plus Platinum Doublet Chemotherapy in NSCLC, sponsored by Galvanize Therapeutics, Inc.. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Galvanize Therapeutics, Inc. · Phase 4, Interventional, and Treatment

Why this study was terminated
Strategic

From the registry’s dates

  • Primary completion was Feb 2024, 2 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • NSCLC

Keywords

  • Lung Neoplasms
  • Thoracic Neoplasms
  • Lung Diseases
  • Antineoplastic Agents
  • Immunologic Factors
  • Immune Checkpoint Inhibitors
  • Nivolumab
  • Gemcitabine
  • Cisplatin
  • Docitaxel
  • Pemetrexed
03

In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's enrollment of 5 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Galvanize Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient is 18 years of age or older
  2. 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
  3. Lesion is targetable for biopsy and PEF delivery per investigator opinion
  4. 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
  5. Patient has been deemed a potential candidate for definitive lung tissue resection by a qualified study investigator
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  7. Patient is able to adhere to protocol requirements
  8. Patient is able to tolerate general anesthesia
  9. Patient is cleared to undergo paralytic anesthesia
  10. Patient has provided informed consent

Exclusion criteria

Exclusion Criteria:

  1. Presence of advanced, inoperable, or metastatic disease
  2. Radiographically suspicious findings for stage IIIA patients indicating a single mediastinal lymph node > 3 cm or multiple mediastinal lymph nodes and, therefore, potentially inoperable
  3. Patient has recurrent NSCLC or has previously been treated for NSCLC
  4. Patient has received chemotherapy or any other cancer therapy in 2 years prior to PEF ablation
  5. Prior treatment with any drug that targets T cell co-regulatory pathways (such as checkpoint inhibitors) in 2 years prior to PEF ablation
  6. Patient requires or is likely to require a pneumonectomy
  7. 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
  8. 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

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Aliya PEF ablation

    Pulsed electric field treatment using the Aliya System

    Device: Aliya Pulsed Electric Fields (PEF) ablation · Drug: Nivolumab plus Platinum Doublet Chemotherapy · Drug: Standard of care neoadjuvant therapy · Other: Surgical Resection

Interventions

  • DeviceAliya Pulsed Electric Fields (PEF) ablation

    Patients will undergo PEF ablation

  • DrugNivolumab plus Platinum Doublet Chemotherapy

    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.

    Also known as: Carboplatinum, Cipsplatin, Pemetrexed, Gemcitabine, Paclitaxel

  • DrugStandard of care neoadjuvant therapy

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

    Also known as: Carboplatinum, Cipsplatin, Pemetrexed, Gemcitabine, Paclitaxel, Vinorelbine

  • OtherSurgical Resection

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Surgical resection

Secondary outcomes

  1. Rate of R0 resection

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

    Time frame: Surgical resection

07

Study locations

3 sites
  • Mayo Clinic Rochester
    Rochester, Minnesota 55905, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Temple University
    Philadelphia, Pennsylvania 19122, United States
08

References and documents

Publications

  • 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. PubMed 35403841 ↗
  • 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. PubMed 24384493 ↗

Individual participant data

Plan to share: No — No plan of data sharing

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05583188
Lead sponsor
Galvanize Therapeutics, Inc.
Responsible party
Sponsor
First posted
Oct 17, 2022
Start date
Feb 1, 2023
Primary completion
Feb 8, 2024
Completion
Mar 18, 2024
Last update
Jul 19, 2024

Study contacts

William Krimsky, MD
study chair · Chief Medical Officer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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