Phase 3
N=419
AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Anticancer Treatment
Bottom Line
View on ClinicalTrials.gov: NCT02151981 ↗Enrolled (actual)
419
Serious AEs
28.9%
Results posted
Jul 2017
Primary outcome: Primary: Progression Free Survival (PFS) by Investigator Assessment — 10.1; 4.4 Months — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chemotherapy (Drug); Cross-over to Osimertinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) by Investigator Assessment |
10.1; 4.4 | <0.001 sig |
| SECONDARY Objective Response Rate (ORR) by Investigator Assessment |
70.6; 31.4 | <0.001 sig |
| SECONDARY Duration of Response (DoR) by Investigator Assessment |
9.7; 4.1 | <0.001 sig |
| SECONDARY Disease Control Rate (DCR) by Investigator Assessment |
93.2; 74.3 | <0.001 sig |
| SECONDARY Tumour Shrinkage by Investigator Assessment |
-46.1; -24.4 | <0.001 sig |
| SECONDARY Secondary: Overall Survival (OS) |
26.8; 22.5 | 0.277 |
Summary
A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene
Eligibility Criteria
Inclusion Criteria
- Subjects with histologically or cytologically documented NSCLC.
- Locally advanced or metastatic NSCLC
- Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
- Eligible to receive treatment with the selected doublet-chemotherapy
- Central confirmation of T790M+ mutation status
- World Health Organization (WHO) performance status 0-1
- At least one lesion, not previously irradiated.
Exclusion Criteria
- • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
- Treatment with more than one prior line of treatment for advanced NSCLC
- Treatment with an approved EGFR-TKI (e.g., erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment
- Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
- Previous treatment with Osimertinib, or a 3rd generation EGFR TKI
For subjects who cross-over to Osimertinib:
- Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
- At least 14 days since last dose of platinum-based doublet chemotherapy
Data sourced from ClinicalTrials.gov (NCT02151981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.