Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

  • STATUS
    Recruiting
  • End date
    Jul 23, 2029
  • participants needed
    12
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Updated on 29 January 2025
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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.

Details
Condition NSCLC Stage IV, ALK Fusion Protein Expression
Age 18years or above
Clinical Study IdentifierNCT05950139
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on29 January 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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