Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)
The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment.
• Histologically and IHC confirmed diagnosis of metastatic NSCLC which has not received any prior anticancer medicinal therapy for metastatic disease.
• Negative for actionable EGFR mutations and ALK rearrangements.
• Patients with recurrence after prior neoadjuvant or adjuvant chemotherapy or radiation therapy or immune checkpoint inhibitors for non-metastatic disease are eligible if recurrence occurred \>6 months after the end of neoadjuvant or adjuvant treatment.
• Documented informed consent of the participant and/or legally authorized representative
• ≥ 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 3 months.
• Patients should have measurable metastatic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST guidelines.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 7 days prior to day 1 of protocol therapy) (except subjects with Gilbert syndrome who must have a total bilirubin level of ≤3.0 × ULN).
⁃ Aspartate aminotransferase (AST) ≤ 2.5 x ULN, unless presence of liver metastases for which ≤ 5 x ULN is allowed (within 7 days prior to day 1 of protocol therapy).
⁃ Alanine aminotransferase (ALT) ≤ 2.5 x ULN, unless presence of liver metastases for which ≤ 5 x ULN is allowed (within 7 days prior to day 1 of protocol therapy).
⁃ Creatinine clearance ≥ 45 ml/min (within 7 days prior to day 1 of protocol therapy).
⁃ Alkaline phosphatase ≤ 3 x ULN (within 7 days prior to day 1 of protocol therapy).
⁃ Hemoglobin ≥ 9 g/dl (within 7 days prior to day 1 of protocol therapy).
⁃ Absolute neutrophil count (ANC) ≥ 1500/ul (within 7 days prior to day 1 of protocol therapy).
⁃ Platelets ≥ 100,000/mm\^3 (within 7 days prior to day 1 of protocol therapy).
⁃ Albumin ≥ 3.0 g/dl (within 7 days prior to day 1 of protocol therapy).
⁃ Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to day 1 of protocol therapy)
⁃ a) Females of non-childbearing potential are defined as: i. ≥ 50 years of age and has not had menses for greater than 1 year ii. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation iii. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.
⁃ Male and female patients of reproductive potential must use effective methods of contraception (defined in Appendix A) or abstain from sexual activity for the course of the study through at least 90 days after the last dose of balstilimab and/or botensilimab
⁃ Is willing and able to comply with the requirements of the protocol.