A Phase III, Open Label, Randomized Study of AZD9291 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 (AURA3)

A Phase III, Open Label, Randomized Study of AZD9291 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 (AURA3) - AURA3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42148

Enrollment

Registered

2014-07-15

Start date

2014-10-10

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer Non small cell lung cancer

Interventions

Patient will be dosed with AZD9291 (80 mg orally, once daily) or with Pemetrexed (500 mg/m2) + carboplatin (AUC5) / cisplatin (75mg/m2) (intravenously, administered on day 1 of each 21 day cycle).

Eligibility

Age

18 Years to 99 Years

Inclusion 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. - Confirmation of EGFR mutation. - Central confirmation of T790M+ mutation status. - World Health Organisation (WHO) performance status 0-1. - At least one lesion, not previously irradiated.

Exclusion criteria

Exclusion criteria: - Treatment with more than one prior line of treatment for advanced NSCLC. - Treatment with an approved EGFR-TKI (eg, erlotinib, gefitinib, afatinib) within 8 days or approximately 5 x half-life of the first dose of study treatment. - Any cytotoxic chemotherapy, 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 an unapproved EGFR-TKI.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS)	—

Secondary

Measure	Time frame
- Objective Response Rate (ORR) - Duration of response (DOR) - Disease Control Rate (DCR) - Tumor shrinkage - Overall survival (OS) - To assess the effect of AZD9291 compared to platinum-based doublet chemotherapy on disease related symptoms and quality of life - To characterise the pharmacokinetics of AZD9291 and metabolites in subjects receiving AZD9291 - Safety - Tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026