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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02276027 | A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer | PHASE2 | COMPLETED | 66 | — | — | Jan 20, 2015 | Oct 15, 2019 | Dec 16, 2020 | 1 | China |
Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (Overall Response (OR) = CR + PR). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| Arm | Type | Description |
|---|---|---|
| BYL719 350 mg QD | EXPERIMENTAL | Patient's tumor must have molecular alteration of the PIK3CA gene. |
| INC280 400 mg BID tab/600 mg BID cap | EXPERIMENTAL | Patient's tumor must have molecular alteration of the c-MET gene. |
| LDK378 750 mg QD | EXPERIMENTAL | Patient's tumor must have ALK or ROS1 gene rearrangement. |
| MEK162 45 mg BID | EXPERIMENTAL | Patient's tumor must have KRAS, NRAS or BRAF mutation. |
| Name | Type | Description |
|---|---|---|
| BYL719 | DRUG | BYL719 was dosed as 350 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take BYL719 exactly as prescribed. |
| INC280 | DRUG | INC280 was dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to takeINC280 exactly as prescribed. |
| LDK378 | DRUG | LDK378 was dosed as 750 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take LDK378 exactly as prescribed. |
| MEK162 | DRUG | MEK162 was dosed as 45 mg twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take MEK162 exactly as prescribed. |
Inclusion Criteria: * Advanced (stage IIIB or stage IV) NSCLC * Must have specific molecular alterations Exclusion Criteria: * Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to...