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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00981058 | First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin | PHASE3 | COMPLETED | 1,093 | — | — | Jan 7, 2010 | May 30, 2024 | Jun 18, 2025 | 182 | United States, Australia +24 |
| NCT00982111 | First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin | PHASE3 | COMPLETED | 633 | — | — | Nov 2, 2009 | Dec 23, 2020 | Jan 11, 2022 | 101 | United States, Australia +18 |
Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Necitumumab + Gemcitabine + Cisplatin | EXPERIMENTAL | Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles. |
| Gemcitabine + Cisplatin | ACTIVE_COMPARATOR | Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles. |
| Necitumumab + Pemetrexed + Cisplatin | EXPERIMENTAL | Necitumumab + Pemetrexed + Cisplatin |
| Pemetrexed + Cisplatin | ACTIVE_COMPARATOR | Pemetrexed + Cisplatin |
| Name | Type | Description |
|---|---|---|
| Necitumumab | BIOLOGICAL | Administered intravenously. Continues until progressive disease, toxicity, noncompliance, or withdrawal. |
| Gemcitabine | DRUG | Administered intravenously. Continues for a maximum of six cycles. |
| Cisplatin | DRUG | Administered intravenously. Continues for a maximum of six cycles. |
| Pemetrexed | DRUG | 500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles |
Inclusion Criteria: * Has histologically or cytologically confirmed squamous NSCLC * Has Stage IV disease at the time of study entry * Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (participants with only t...