RecruitingPhase 1 / Phase 2NCT05950139

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

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.

Checked against the public recordLast updated Jul 28, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1 / Phase 2
U.S. locations1
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Interventions being studied
Biological: Peptide vaccine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Johns Hopkins UniversityBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 28, 2026. Always confirm current availability with the study team.

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