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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01165021 | A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 19 | — | — | Nov 1, 2010 | Apr 1, 2016 | Sep 25, 2019 | 7 | Italy |
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
| Arm | Type | Description |
|---|---|---|
| Pemetrexed + Cisplatin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pemetrexed | DRUG | 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles |
| Cisplatin | DRUG | 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles |
| Folic Acid | DRUG | Administered orally. |
| Vitamin B12 | DRUG | Administered Intramuscular injection. |
| Dexamethasone | DRUG | Administered orally. |
Inclusion Criteria: * Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy * Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2) * Tumor considered potentially resectable * Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale ...