A Vaccine for the Treatment of Patients with Advanced ALK Rearrangement Positive Non-Small Cell Lung Cancer

Inclusion Criteria

• Males or females at least 18 years old
• 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) immunohistochemistry (IHC), (3) tissue next generation sequencing (NGS), or (4) circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) NGS as defined by a Clinical Laboratory Improvement Act (CLIA)-certified tumor or plasma based genomic testing platform performed either through a local laboratory or through our central laboratory
• On-going 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
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L or 1500/mm^3
• Platelet count >= 75 x 10^9/L or 75,000/mm^3
• Hemoglobin (Hb) >= 9 g/dL (or 5.59 mmol/L) at baseline
• Serum creatinine =< 1.5 × upper limit of normal (ULN) or >= 60 mL/minute for subjects with creatinine levels > 1.5 × the institutional ULN
• Serum total bilirubin =< 1.5 × ULN or direct bilirubin < 30% of total bilirubin for subjects with total bilirubin levels > 1.5 × ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 × ULN except for subjects with liver metastasis (mets) for whom ALT and AST should be =< 5 × ULN
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]). NOTE: If a patient has a positive or indeterminate serum or urine pregnancy test, then an ultrasound must be done to rule out pregnancy to enroll on trial * WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 4 weeks (duration of ovulatory cycle) for a total of 5 months post treatment completion * Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion * At least one barrier method of contraception must be employed by all sexually active patients (male and female), regardless of other methods, to prevent the transfer of body fluids
• Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

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
• 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: * Systemic or topical steroids at immunosuppressive doses (> 10 mg/day of prednisone or equivalent). Inhaled or topical steroids, and adrenal replacement steroid doses =< 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease * 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 standard of care radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed
• Known or suspected hypersensitivity to the vaccine or its excipients
• Be pregnant, planning a pregnancy, or breastfeeding
• Uncontrolled infection including, but not limited to, the requirement for intravenous (IV) antibiotics
• Active hepatitis B or hepatitis C infection with detectable DNA or ribonucleic acid (RNA) viral load. Testing is not required in the absence of history
• Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug