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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07323641 | Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer | PHASE2 | RECRUITING | 60 | — | — | Feb 19, 2026 | Feb 1, 2028 | Apr 20, 2026 | 1 | United States |
Defined as complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The ORR estimate and its associated 95% confidence interval (CI) will be calculated.
The Kaplan-Meier curve and its 95% CI will be used to infer the PFS. The median time PFS will be compared to median survival time of 4.2 months base on historic controls, using Brookmeyer-Crowley method.
| Arm | Type | Description |
|---|---|---|
| Treatment (telisotuzumab vedotin and osimertinib) | EXPERIMENTAL | Patients receive telisotuzumab vedotin IV on days 1 and 15 of cycles 1-3 and on day 1 of subsequent cycles. Patients also receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, brain MRI, if needed, and blood sample collection throughout the study. Patients also optionally undergo tumor biopsy during follow-up. |
| Name | Type | Description |
|---|---|---|
| Biopsy Procedure | PROCEDURE | Undergo tumor biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Osimertinib | DRUG | Given PO |
| Survey Administration | OTHER | Ancillary studies |
| Telisotuzumab Vedotin | BIOLOGICAL | Given IV |
Inclusion Criteria: * Male or female ≥ 18 years of age and willing and able to provide informed consent * Cytologically or histologically confirmed non small cell lung cancer (NSCLC), which is incurable with an activating and sensitizing EGFR mutation (e.g., exon 20 insertion mutations are excluded...