Study identifier:D5169C00001
ClinicalTrials.gov identifier:NCT04035486
EudraCT identifier:2019-000650-61
CTIS identifier:N/A
A Phase III, Open-label, Randomized Study of Osimertinib with or without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients with Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).
Non-small Cell Lung Cancer
Phase 3
No
Osimertinib, Pemetrexed/Carboplatin, Pemetrexed/Cisplatin
All
587
Interventional
18 Years - 110 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Osimertinib 80mg QD Osimertinib (AZD9291) 80mg QD. All patients randomized into this will only receive Osimertinib 80mg. Dose may be reduced to allow for the management of IP related toxicity. | Drug: Osimertinib Drug: Osimertinib (Oral) Other Names: AZD9291 Other Name: AZD9291 |
Experimental: Osimertinib 80 mg QD and platinum-based chemotherapy Osimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks. Dose may be reduced to allow for the management of IP related toxicity. | Drug: Pemetrexed/Carboplatin Drug: Pemetrexed (500 mg/m2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks. Drug: Pemetrexed/Cisplatin Drug: Pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks. |