Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) NSCLC

Conditions
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NSCLC Stage IV, ALK Fusion Protein Expression

Intervention / Treatment
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* Biological: Peptide vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced ALK+ NSCLC<br>All patients will receive the intervention | Biological: Peptide vaccine<br>* Peptide vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |