Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC

NCT05950139 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: J23120IRB00398546
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.

Conditions

NSCLC Stage IV; ALK Fusion Protein Expression

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-related adverse events

  The safety of administering the ALK peptide vaccine will be assessed by the occurrence of the following adverse events: * Grade 3 or above drug-related toxicities * Drug-related toxicity by grade * Vaccine site reactions after vaccine injections * Immune-related adverse events (AEs) * Unacceptable toxicities * Treatment-emergent changes from normal to abnormal values in key laboratory parameters

  Up to 2 years

• Vaccine-specific immune response

  Vaccine-specific response will be evaluated by the fold change in interferon-producing mutant-ALK-specific CD8 and CD4 T cells in the peripheral blood.

  Up to 2 years

Study Arms (1)

Advanced ALK+ NSCLC

EXPERIMENTAL

All patients will receive the intervention

Biological: Peptide vaccine

Interventions

Peptide vaccine BIOLOGICAL

Peptide vaccine

Advanced ALK+ NSCLC

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
• Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS
• Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months
• No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Males or females at least 18 years old

You may not qualify if:

• Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.
• Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine
• Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine
• Systemic immune suppression:
• Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
• Other clinically relevant systemic immune suppression
• Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted
• Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Oncovir, Inc.: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Protein Subunit Vaccines

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Vincent Lam, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Lam, MD

CONTACT

410-955-8964; ThoracicCancerTrials@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: May 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)