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NCT05950139 | RECRUITING | NSCLC Stage IV

Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC
Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease

NSCLC Stage IV

ALK Fusion Protein Expression

Intervention/treatment

Peptide vaccine

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pilot Study of a Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC
Actual Study Start Date : 2024-05-13
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2029-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

Location Details

NCT05950139

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287