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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01828099 | LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer | PHASE3 | COMPLETED | 376 | — | — | Jul 9, 2013 | Jan 7, 2024 | Jan 16, 2025 | 167 | Argentina, Australia +27 |
| NCT01828112 | LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib | PHASE3 | COMPLETED | 231 | — | — | Jun 28, 2013 | Nov 10, 2023 | Feb 7, 2025 | 97 | United States, Belgium +18 |
| NCT02299505 | Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC) | PHASE1 | COMPLETED | 306 | — | — | Apr 9, 2015 | Mar 6, 2020 | Feb 9, 2022 | 73 | United States, Australia +22 |
PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method.
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Pharmacokinetics (PK) parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
| Arm | Type | Description |
|---|---|---|
| Ceritinib | EXPERIMENTAL | Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state. |
| Chemotherapy | ACTIVE_COMPARATOR | Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
| ceritinib 450 mg with a low-fat meal | EXPERIMENTAL | Oral ceritinib QD (21 days/ cycle) at a dose of 450 mg (3×150 mg/capsule) administered in the morning immediately (within 30 minutes)following a low-fat meal. |
| ceritinib 600 mg with a low-fat meal | EXPERIMENTAL | Oral ceritinib QD (21 days/ cycle) at a dose of 600 mg (4×150 mg/capsule) administered in the morning immediately (within 30 minutes) following a low-fat meal. |
| ceritinib 750 mg on an empty stomach | ACTIVE_COMPARATOR | Oral ceritinib QD (21 days/ cycle) at a dose of 750 mg (5×150 mg/capsule) administered in the morning on an empty stomach (i.e., fasted from food and drink except water) |
| Name | Type | Description |
|---|---|---|
| Ceritinib | DRUG | Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. |
| Pemetrexed | DRUG | Pemetrexed was administered at a dose of 500 mg/m\^2 as an intravenous (iv) infusion on Day 1 of each 21-day cycle |
| Cisplatin | DRUG | Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 every 21 days for up to 4 cycles. |
| Carboplatin | DRUG | Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles |
| Docetaxel | DRUG | Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m\^2 every 21 days. |
Key Inclusion Criteria: 1. The patient had a histologically or cytologically confirmed diagnosis of non-squamous Non-small cell lung cancer (NSCLC) that was Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test. The test was performed at Novartis desig...