protocolSection identificationModule nctId: NCT06322108, orgStudyIdInfo id: IMMONC0008, briefTitle: Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2030-04, completionDateStruct date: 2030-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Immune Oncology Research Institute, class: OTHER, collaborators name: Agenus Inc., descriptionModule briefSummary: 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., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Botensilimab + Balstilimab, outcomesModule primaryOutcomes measure: 12-Month Progression-Free Survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Time to Next Treatment (TTNT), secondaryOutcomes measure: Overall Survival (OS) Time, secondaryOutcomes measure: Frequency, severity, and duration of treatment emergent adverse events (TEAEs) (Safety and tolerability), secondaryOutcomes measure: Health-related quality of life (HRQoL) according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), secondaryOutcomes measure: Health-related quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC29), secondaryOutcomes measure: Health-related quality of life according to the 5 Level EuroQol 5 Dimension (EQ-5D-5L) questionnaire, secondaryOutcomes measure: Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and 12-month progression-free survival, secondaryOutcomes measure: Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and objective response rate, secondaryOutcomes measure: Correlation between existence of liver metastases on imaging at baseline and 12-month progression-free survival, secondaryOutcomes measure: Correlation between existence of liver metastases on imaging at baseline and objective response rate, secondaryOutcomes measure: Level of circulating tumor DNA (ctDNA) at baseline and at different time points after start of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hematology Center named after prof. R. Yeolyan, city: Yerevan, zip: 0014, country: Armenia, contacts name: Samvel Bardakhchyan, MD, PhD, role: CONTACT, phone: +374 (010) 283800, email: samvelbardakhchyan@gmail.com, contacts name: Amalya Sargsyan, MD, role: CONTACT, phone: +374 (010) 283800, email: amalyasargsyan@gmail.com, geoPoint lat: 40.18111, lon: 44.51361, hasResults: False