Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

Eligibility 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
• 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