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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06775483 | Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study | PHASE2 | NOT YET_RECRUITING | 220 | — | — | Jan 17, 2025 | Nov 30, 2027 | Jan 15, 2025 | - | — |
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Arm | Type | Description |
|---|---|---|
| Part I: Cohort 1（JSKN016） | EXPERIMENTAL | Enrolled subjects with harboring sensitive EGFR mutations who have already received tyrosine kinase inhibitor (TKI) therapy.Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol. |
| Part I: Cohort 2（JSKN016） | EXPERIMENTAL | Enrolled subjects with negative driver genes who have already received immunotherapy. Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol. |
| Part I: Cohort 3（JSKN016） | EXPERIMENTAL | Enrolled subjects with positive driver genes who have failed standard therapy.Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol. |
| Part II：Cohort A（JSKN016） | EXPERIMENTAL | Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol. |
| Part II：Cohort B（Docetaxel） | ACTIVE_COMPARATOR | Receive Docetaxel monotherapy , administered intravenously at the dosage specified in the protocol. |
| Name | Type | Description |
|---|---|---|
| JSKN016 | DRUG | Administered intravenously according to protocol. |
| Docetaxel | DRUG | Administered intravenously according to protocol. |
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form. 2. Age ≥ 18 years old, male or female. 3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 4. Expected survival ≥ 3 months. 5. Histologically or cytologically confirmed locally advance...