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

NCT ID: NCT05950139

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2029-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Advanced ALK+ NSCLC

All patients will receive the intervention

Group Type: EXPERIMENTAL

Peptide vaccine

Intervention Type: BIOLOGICAL

Peptide vaccine

Interventions

Peptide vaccine

Peptide vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)

2. 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

3. Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months

4. No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

6. Males or females at least 18 years old

Exclusion Criteria

1. 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.

2. Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine

3. Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine

4. Systemic immune suppression:

1. Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)

2. Other clinically relevant systemic immune suppression

5. 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

6. Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncovir, Inc.

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Lam, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vincent Lam, MD

Role: CONTACT

ThoracicCancerTrials@jhmi.edu

410-955-8964

Facility Contacts

Vincent Lam, MD

Role: primary

ThoracicCancerTrials@jhmi.edu

410-955-8964

Other Identifiers

IRB00398546

Identifier Type: OTHER

Identifier Source: secondary_id

J23120

Identifier Type: -

Identifier Source: org_study_id