A Pair of Radioactive Drugs for Diagnosing and Treating Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria

• [68GA]GA DOTA-5G PET/CT INCLUSION:
• Ability to understand and willingness to sign a written informed consent document
• Age 18 or more years
• Pathologically confirmed NSCLC with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis)
• Participant must have documented tumor progression for metastatic disease during or following at least one prior Food and Drug Administration (FDA) approved systemic regimen as established by diagnostic imaging
• Available archival tumor tissue (excisional, core, or fine needle aspiration [FNA] is acceptable). Tissue from a metastatic site is preferred when available
• Eastern Cooperative Oncology Group performance status ≤ 2
• Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to [68Ga]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to grade 1 or baseline
• Absolute neutrophil count (ANC) ≥ 1000 cells/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8 g/dL
• Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
• Total bilirubin ≤ 2 times ULN
• Creatinine ≤ 2 times ULN
• Anticipated life expectancy ≥ 3 months
• Able to remain motionless for up to 30-60 minutes per scan
• [177LU]LU DOTA-ABM-5G THERAPY INCLUSION:
• Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
• The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (standardized uptake value maximum [SUVmax] > 2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging). Patients with a history of brain metastases and or any clinical concern for brain metastases will be evaluated with brain magnetic resonance imaging (MRI) as per standard of care for patients with metastatic NSCLC

Exclusion Criteria

• [68GA]GA DOTA-5G AND [177LU]LU DOTA-ABM-5G THERAPY EXCLUSION:
• Participants with class 3 or 4 New York Heart Association (NYHA) congestive heart failure
• Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
• Pregnant or lactating women
• Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
• Has a prior or concurrent malignancy whose natural history or treatment has the potential (in the opinion of the Principal investigators) to interfere with the safety or efficacy assessment of the investigational regimen
• Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
• Known interstitial lung disease or pre-existing pulmonary fibrosis
• International normalized ratio (INR) > 2.0: partial thromboplastin time (PTT) > 15 seconds above ULN