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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06767514 | Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1 | PHASE3 | RECRUITING | 780 | — | — | Feb 27, 2025 | Jun 1, 2029 | Feb 24, 2026 | 202 | United States, Canada +14 |
| NCT05899608 | Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients | PHASE3 | RECRUITING | 1,600 | — | — | Oct 26, 2023 | Dec 31, 2029 | Apr 30, 2026 | 253 | United States, Belgium +15 |
| NCT07535463 | A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer | PHASE1 | RECRUITING | 53 | — | — | Apr 10, 2026 | Apr 1, 2028 | Apr 17, 2026 | 7 | United States |
| NCT07535437 | A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer | PHASE1 | RECRUITING | 66 | — | — | Apr 9, 2026 | Apr 1, 2028 | Apr 21, 2026 | 7 | United States |
per NCI CTCAE version 5.0 criteria
defined as the time of treatment start to radiologically confirmed intracranial progression or death from any cause.
Three participants will be enrolled at starting dose level and assessed for dose limiting toxicities (DLTs) for 1 full cycle (21 days) in cohort A and 2 full cycles (42 days) for cohort B. Toxicity will be graded according to NCI CTCAE version 5.
defined as the proportion of patients who remained alive and progression-free at 6 months) will be computed by Kaplan-Meier estimates and reduced to a standard sample proportion in the absence of censoring, with the follow-up starting at the initiation of therapy.
by RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Arm A - Ivonescimab | EXPERIMENTAL | Subject will receive ivonescimab as an IV injection |
| Arm B - Pembrolizumab | ACTIVE_COMPARATOR | Subject will receive pembrolizumab as an IV injection |
| Arm A - Ivonescimab and chemotherapy | EXPERIMENTAL | Subject will receive ivonescimab and chemotherapy |
| Arm B - Pembrolizumab and chemotherapy | ACTIVE_COMPARATOR | Subject will receive pembrolizumab and chemotherapy |
| Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery | EXPERIMENTAL | In the Phase I portion of the study, patients with NSCLC brain metastases will receive ivonescimab at a starting dose of 10 mg/kg on Day 1 (with chemotherapy), followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10. Following a toxicity check at Day 21, patients will receive standard dosing of ivonescimab with chemotherapy at the discretion of the medical oncologist. In the Phase II portion of the study, patients will receive the RP2D from the initial phase of ivonescimab and chemotherapy on C1D1, followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10. |
| Cohort A (ivonescimab + Dato-DXd) Phase IA | EXPERIMENTAL | 3 + 3 escalation (2 dose levels) |
| Cohort B (Ivonescimab + Osimertinib) Phase IB | EXPERIMENTAL | 3 + 3 escalation (2 dose levels) |
| Cohort A (ivonescimab + Dato-DXd) (Phase II) | EXPERIMENTAL | Every 3 weeks |
| Cohort B (Ivonescimab + Osimertinib) (Phase II) | EXPERIMENTAL | Ivonescimab every 3 weeks + Osimertinib daily |
| Name | Type | Description |
|---|---|---|
| Ivonescimab Injection | BIOLOGICAL | Subject will receive ivonescimab as an IV injection |
| Pembrolizumab Injection | BIOLOGICAL | Subject will receive Pembrolizumab as an IV injection |
| Ivonescimab | DRUG | Ivonescimab will be administered IV on Day 1 of the first cycle starting at 10 mg/kg with chemotherapy. Dose escalation will proceed to 15 mg/kg and 20 mg/kg as tolerated. |
| Stereotactic Radiosurgery | RADIATION | (9Gy x 3 fractions) starting on Days 7-10. |
| Dato-DXd | DRUG | dose escalation 4 mg/kg 6 mg/kg |
| Osimertinib | DRUG | dose escalation 40mg 80 mg |
Inclusion Criteria: * Age ≥ 18 years old at the time of enrollment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1 * Expected life expectancy ≥ 3 months * Metastatic (Stage IV) NSCLC * Histologically or cytologically confirmed squamous or non-squamous NSCLC * Tumor dem...