Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Jul 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new cancer vaccine designed to help patients with advanced ALK-positive non-small cell lung cancer (NSCLC). The goal is to see if this vaccine can safely prevent or delay the cancer from becoming resistant to current treatments. If you're currently being treated with specific ALK-targeted therapies and have stable disease, you may be eligible to participate in this study.

To join, participants need to be at least 18 years old and have a confirmed diagnosis of stage IV NSCLC with a specific genetic change called ALK rearrangement. They should also be receiving ongoing treatment with medications like crizotinib or alectinib for at least four months. Throughout the trial, participants will receive the vaccine and be monitored for any side effects and changes in their condition. It's important to know that certain conditions, like having other active cancers or recent immune system treatments, might prevent someone from joining the study. This trial is currently recruiting participants, and it's a chance to be part of research that could help improve treatment options for lung cancer patients.

Gender

ALL

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