Osimertinib Maintenance After Definitive Chemoradiation in Patients With Unresectable EGFR Mutation Positive Stage III Non-small-cell Lung Cancer: LAURA Trial in Progress
| Autor: | Shun Lu, Suresh S. Ramalingam, Mustafa Ozguroglu, Ignacio Casarini, Manuel Cobo, M. Saggese, Terufumi Kato, Toon van der Gronde, Rachel Hodge |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine Oncology Cancer Research medicine.medical_specialty Lung Neoplasms medicine.medical_treatment Targeted therapy 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Maintenance therapy Double-Blind Method Internal medicine Carcinoma Non-Small-Cell Lung Medicine Humans Osimertinib In patient Epidermal growth factor receptor Stage (cooking) Lung cancer Protein Kinase Inhibitors Neoplasm Staging Creatinine Acrylamides Aniline Compounds biology business.industry Chemoradiotherapy medicine.disease Progression-Free Survival ErbB Receptors Survival Rate 030104 developmental biology chemistry 030220 oncology & carcinogenesis Mutation biology.protein business |
| Zdroj: | Clinical lung cancer. 22(4) |
| ISSN: | 1938-0690 |
| Popis: | The LAURA trial (NCT03521154) will evaluate the efficacy and safety of osimertinib as maintenance therapy in patients with locally advanced, unresectable, epidermal growth factor receptor mutation-positive (EGFRm), stage III non-small-cell lung cancer (NSCLC) without disease progression during/following definitive platinum-based chemoradiation therapy (CRT). Eligible patients include adults aged ≥ 18 years (≥ 20 years in Japan) with locally advanced, unresectable, stage III NSCLC with local/central confirmation of an EGFR exon 19 deletion/L858R mutation. Patients must have received ≥ 2 cycles of concurrent/sequential platinum-based CRT, have no investigator-assessed progression, and have creatinine 1.5 × upper limit of normal and creatinine clearance ≥ 30 mL/min. In this phase III trial, patients will be randomized 2:1 to once-daily osimertinib 80 mg or placebo, until objective radiological disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, confirmed by blinded independent central review (BICR). The primary objective is to assess the efficacy of osimertinib per BICR-confirmed progression-free survival (PFS). Secondary objectives include central nervous system PFS, overall survival, PFS by mutation status and safety. Patients with BICR-confirmed disease progression (or investigator-confirmed progression if after primary PFS analysis) may be unblinded and receive open-label osimertinib; all will have post-progression follow-up. Serious adverse events and adverse events of special interest will be collected throughout the trial and survival follow-up. The first patient was enrolled in July 2018, with results expected in late 2022. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect