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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01439568 | A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma | PHASE2 | COMPLETED | 90 | — | — | Sep 1, 2011 | Aug 1, 2016 | Jul 23, 2019 | 15 | United States |
PFS is defined as the time from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For participants who are still alive at the time of analysis and without evidence of tumor progression, PFS will be censored at the date of the most recent objective progression-free observation. For participants who receive subsequent anticancer therapy (except PCI) prior to objective disease progression or death, PFS will be censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.
| Arm | Type | Description |
|---|---|---|
| LY2510924 + Carboplatin + Etoposide | EXPERIMENTAL | LY2510924: 20 milligram (mg) administered once daily as a subcutaneous(SC) injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m\^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles. |
| Carboplatin + Etoposide | ACTIVE_COMPARATOR | Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m\^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles. |
| Name | Type | Description |
|---|---|---|
| LY2510924 | DRUG | Administered subcutaneous injection |
| Carboplatin | DRUG | Administered intravenously |
| Etoposide | DRUG | Administered intravenously |
Inclusion Criteria: * histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma * measurable disease as defined by the New Response Evaluation Criteria in Solid Tumors (RECIST): Revised RECIST Guideline (version 1.1) * no prior systemic chemotherapy, immunotherapy,...