A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Authors
Category Primary study
Registry of TrialsJapan Pharmaceutical Information Center
Year 2018
INTERVENTION: Intervention name : Alectinib INN of the intervention : Alectinib Dosage And administration of the intervention : 600 mg orally BID for 24 months Control intervention name : Cisplatin, Vinorelbine, Gemcitabine, Pemetrexed, Carboplatin INN of the control intervention : Cisplatin, Vinorelbine, Gemcitabine, Pemetrexed, Carboplatin Dosage And administration of the control intervention : Patients will receive one of the platinum based chemotherapy regimens for 4 cycles (1 cycle = 21 days). [Cisplatin; 75 mg/m^2 IV on Day1] [Vinorelbine; 25 mg/m^2 IV on Days 1 and 8] [Gemcitabine; 1250 mg/m^2 IV on Days 1 and 8] [Pemetrexed; 500 mg/m^2 IV on Day 1] [Carboplatin; for patients who experience unacceptable toxicity with cisplatin, carboplatin can be used] CONDITION: Non‐Small Cell Lung Cancer PRIMARY OUTCOME: Disease‐free Survival (DFS) SECONDARY OUTCOME: ‐ Overall Survival (OS); ‐ PK; ‐ Safety; percentage of participants with adverse events INCLUSION CRITERIA: ‐ Complete resection of NSCLC at 4‐12 weeks before enrollment ‐ Histologically confirmed Stage IB (tumor >= 4 cm) to Stage IIIA (T2‐3 N0, T1‐3 N1, T1‐3 N2, T4 N0‐1) NSCLC ‐ Documented ALK‐positive disease according to an FDA‐approved and CE‐marked test ‐ Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1 ‐ Adequate hematologic and renal function
Epistemonikos ID: bfe48b5d526c5992f8ec85f2a40cefe622891bcc
First added on: Aug 24, 2024