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

NSCLC Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05583188
• Other study ID #: CSP-00012
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Galvanize Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Other protocol defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Device:
• Aliya Pulsed Electric Fields (PEF) ablation
Patients will undergo PEF ablation

Drug:
• 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.
• 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.

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

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Galvanize Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of R0 resection	R0 - no cancer cells seen microscopically at the primary tumor site	Surgical resection

External Links

•   CheckMate 816 Clinical Study