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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02839265 | FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer | PHASE2 | COMPLETED | 33 | — | — | Jul 1, 2016 | Nov 22, 2024 | Apr 28, 2026 | 1 | United States |
The primary endpoint is progression-free survival rate at four months (PFS4), defined as the rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\~4 months) after initiation of study therapy.
| Arm | Type | Description |
|---|---|---|
| SBRT + FLT3 Ligand Immunotherapy | EXPERIMENTAL | Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy. FLT3 Ligand Therapy (CDX-301) * Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT. * Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression). * Study therapy will be discontinued in cases of treatment-related toxicity or disease progression. |
| Name | Type | Description |
|---|---|---|
| FLT3 Ligand Therapy (CDX-301) | DRUG | See Arm 1 descriptions |
| Stereotactic Body Radiotherapy (SBRT) | RADIATION | See Arm 1 descriptions |
Inclusion Criteria: * AJCC stage 3 or 4 histologically proven NSCLC not amenable to curative therapy * Age \>= 18 years * Prior treatment with at least one standard chemotherapy regimen or targeted agent prior to enrollment * Radiological assessment within 21 days prior to study entry demonstrating...