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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04699123 | The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 159 | — | — | Feb 4, 2021 | Jun 30, 2025 | May 13, 2025 | 1 | United States |
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 in arm 1a
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2
| Arm | Type | Description |
|---|---|---|
| Arm 1a - NC318 only | EXPERIMENTAL | At the discretion of the treating physician, advanced NSCLC patients on arm 1a will receive NC318 alone. |
| Arm 1b - NC318 and Pembrolizumab | EXPERIMENTAL | At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab. |
| Arm 1c - NC318 and Pembrolizumab | EXPERIMENTAL | At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab. |
| Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab | EXPERIMENTAL | Arm 2 will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive therapy with NC318 in combination with pembrolizumab. |
| Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab | EXPERIMENTAL | Arm 2a will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive combination therapy with NC318 and pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| NC318 800 mg | DRUG | NC318 will be given intravenously (IV) weekly for 8 doses and then every 2 weeks for patients receiving combination therapy treatment or weekly for patient receiving NC318 in monotherapy. |
| NC318 400 mg | DRUG | NC318 will be given intravenously (IV) every 2 weeks. |
| Pembrolizumab | DRUG | Pembrolizumab 200 mg will be given IV every 3 weeks |
Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the American Joint Committee /AJCC staging system) * ECOG performance status of 0 to 1 * Measurable di...