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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-03-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aliya PEF ablation

Pulsed electric field treatment using the Aliya System

Group Type EXPERIMENTAL

Aliya Pulsed Electric Fields (PEF) ablation

Intervention Type DEVICE

Patients will undergo PEF ablation

Nivolumab plus Platinum Doublet Chemotherapy

Intervention Type DRUG

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.

Standard of care neoadjuvant therapy

Intervention Type DRUG

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

Surgical Resection

Intervention Type OTHER

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

Interventions

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Aliya Pulsed Electric Fields (PEF) ablation

Patients will undergo PEF ablation

Intervention Type DEVICE

Nivolumab 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.

Intervention Type DRUG

Standard 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.

Intervention Type DRUG

Surgical Resection

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

Intervention Type OTHER

Other Intervention Names

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Carboplatinum Cipsplatin Pemetrexed Gemcitabine Paclitaxel Carboplatinum Cipsplatin Pemetrexed Gemcitabine Paclitaxel Vinorelbine

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No