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

NCT05583188 | Terminated Phase 4 DMC FDA Device

• 1 other identifier: CSP-00012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

NSCLC

Keywords

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

Outcome Measures

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.

  Surgical resection

Secondary Outcomes (1)

• Rate of R0 resection

  Surgical resection

Study Arms (1)

Aliya PEF ablation

EXPERIMENTAL

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

Aliya Pulsed Electric Fields (PEF) ablation DEVICE

Patients will undergo PEF ablation

Aliya PEF ablation

Nivolumab plus Platinum Doublet Chemotherapy 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.

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

Aliya PEF ablation

Standard of care neoadjuvant therapy DRUG

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

Aliya PEF ablation

Surgical Resection OTHER

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

Aliya PEF ablation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galvanize Therapeutics, Inc.: lead

Study Sites (3)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (2)

• 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.

  PMID: 35403841 BACKGROUND

• 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.

  PMID: 24384493 BACKGROUND

Related Links

• CheckMate 816 Clinical Study

MeSH Terms

Conditions

Lung Neoplasms; Thoracic Neoplasms; Lung Diseases

Interventions

Nivolumab; Carboplatin; Pemetrexed; Gemcitabine; Paclitaxel; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• William Krimsky, MD

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: February 1, 2023
• Primary Completion: February 8, 2024
• Study Completion: March 18, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)