A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer (NeoADAURA)
A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer (NeoADAURA)
This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The two arms with SoC chemotherapy (placebo plus chemotherapy versus osimertinib plus chemotherapy) will be double-blinded and placebo-controlled.
Osimertinib monotherapy arm will be open label, sponsor-blind.
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer
Actual Study Start Date: December 24, 2020
Estimated Primary Completion Date: March 26, 2024
Estimated Study Completion Date: March 29, 2029
Arm:
- Placebo Comparator: Arm 1: Placebo with platinum-based chemotherapy
- Experimental: Arm 2: Osimertinib with platinum-based chemotherapy
- Experimental: Arm 3: Osimertinib monotherapy
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 328 |
| Actual Study start date | 24 December 2020 |
| Estimated Study Completion Date | 29 March 2029 |