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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07217301 | IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed | PHASE3 | RECRUITING | 600 | — | — | Nov 26, 2025 | Dec 1, 2029 | Apr 27, 2026 | 44 | United States, China |
To compare the overall survival (OS) of IBI363 (treatment group) vs. docetaxel (control group) in participants with unresectable locally advanced or metastatic squamous NSCLC with disease progression on or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
| Arm | Type | Description |
|---|---|---|
| IBI363 | EXPERIMENTAL | IBI363 is a first-in-class bispecific monoclonal antibody (mAb) comprised of an interleukin-2 (IL-2) mutein fused with a recombinant anti-programmed cell death protein 1 (anti-PD-1) mAb. IBI363 was precisely designed and constructed to afford targeted binding of tumor-specific CD8+ T cells (TSTs) that co-express PD-1 and CD25 (IL2Ra) receptors. The mechanism of action of IBI363 is blocking the PD-(L)1 and activating the IL-2 pathways simultaneously to reverse T cell exhaustion and promote activation of T cells and natural killer (NK) cells, and consequently eliminate tumor cells. |
| Control | ACTIVE_COMPARATOR | Docetaxel or comparable generic brand |
| Name | Type | Description |
|---|---|---|
| IBI363 | DRUG | Investigational product will be administered by IV infusion |
| Control Arm | DRUG | Comparator product will be administered by IV infusion |
Inclusion Criteria: 1. Willing to sign the written informed consent form and be able to comply with the visit schedule and related procedures specified in the protocol. 2. Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater. ...