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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01395758 | Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 96 | — | — | Jul 1, 2011 | Aug 1, 2016 | Apr 3, 2018 | 13 | United States |
Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or progression of existing non-target lesions are also considered progression.
| Arm | Type | Description |
|---|---|---|
| tivantinib (ARQ 197) plus erlotinib arm | EXPERIMENTAL | Eligible subjects will be randomly assigned to receive erlotinib plus tivantinib (ARQ 197). Treatment will be open-label and continue until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. |
| Chemotherapy arm | ACTIVE_COMPARATOR | Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy can be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| ARQ 197 plus erlotinib | DRUG | Eligible subjects will be randomly assigned to receive erlotinib plus ARQ 197. |
| Pemetrexed, docetaxel or gemcitabine | DRUG | Investigator's choice of a single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered according to the approved label. |
Inclusion Criteria: 1. Provide signed and dated informed consent prior to study-specific screening procedures 2. Male or female at least 18 years of age 3. Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IVA/IVB) NSCLC 4. Documented KRAS mutation positive ...