Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06322108 | Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) | PHASE2 | ACTIVE NOT_RECRUITING | 45 | — | — | Jun 13, 2024 | Apr 1, 2030 | Jun 8, 2026 | 1 | Armenia |
12-Month PFS is defined as the proportion of patients who remain alive and progression-free at 12 months from the first dose of investigational drug, where tumor progression is documented per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and modified Response Evaluation Criteria in Solid Tumors version 1.1 for immune-based therapeutics (iRECIST) as assessed by investigator.
| Arm | Type | Description |
|---|---|---|
| Botensilimab + Balstilimab | EXPERIMENTAL | botensilimab 75 mg IV every 6 weeks (up to 4 doses) + balstilimab 240 mg IV every 2 weeks |
| Name | Type | Description |
|---|---|---|
| Botensilimab + Balstilimab | DRUG | Botensilimab is a fragment crystallizable (Fc)-engineered human immunoglobulin G1 (IgG1) monoclonal antibody that targets cytotoxic T lymphocyte-associated protein 4 (CTLA-4). Balstilimab is a human monoclonal antibody that targets programmed cell death protein 1 (PD-1). |
Inclusion Criteria: 1. Histologically and IHC confirmed diagnosis of metastatic NSCLC which has not received any prior anticancer medicinal therapy for metastatic disease. 2. Negative for actionable EGFR mutations and ALK rearrangements. 3. Patients with recurrence after prior neoadjuvant or adjuva...