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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01248247 | BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 334 | — | — | Jun 2, 2011 | Nov 30, 2020 | Jan 12, 2022 | 2 | United States |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Group 1 - Erlotinib | EXPERIMENTAL | Erlotinib 150 mg by mouth each day of a 28 day cycle. |
| Group 2 - Erlotinib + MK-2206 | EXPERIMENTAL | Erlotinib 150 mg by mouth each day of a 28 day cycle. MK-2206 135 mg by mouth every week of a 28 day cycle. |
| Group 3 - AZD6244 + MK-2206 | EXPERIMENTAL | AZD6244 100 mg by mouth daily of a 28 day cycle. MK-2206 100 mg by mouth every week of a 28 day cycle. |
| Group 4 - Sorafenib | EXPERIMENTAL | Sorafenib 400 mg by mouth twice a day for a 28 day cycle. |
| Name | Type | Description |
|---|---|---|
| Erlotinib | DRUG | 150 mg by mouth each day of a 28 day cycle. |
| AZD6244 | DRUG | 100 mg by mouth daily of a 28 day cycle. |
| MK-2206 | DRUG | 100 mg by mouth every week of a 28 day cycle. |
| Sorafenib | DRUG | 400 mg by mouth twice a day for a 28 day cycle. |
Inclusion Criteria: 1. The subject has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration. 2. The subject has a diagnosis of either advanced, incurable stage IIIB or stage IV NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen, or...