AZD9291 versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 1

• Conditions: ocally Advanced or Metastatic Non-Small Cell Lung Cancer where Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and where Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene; MedDRA version: 19.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000594-39-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-02
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 410

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

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 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 AZD9291, or a 3rd generation EGFR TKI.
- Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months of starting 1st EGFR TKI treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of AZD9291 compared with platinum-based doublet chemotherapy by assessment of Progression Free Survival (PFS);Secondary Objective: To further assess the efficacy of AZD9291 compared with platinum-based doublet chemotherapy in terms of: <br>- Objective Response Rate (ORR)<br>- Duration of Response (DoR)<br>- Disease Control Rate (DCR)<br>- Overall Survival (OS)<br>- Tumour shrinkage<br><br>To assess the effect of AZD9291 compared to platinum-based doublet chemotherapy on subjects’ disease-related symptoms and health related quality of life (HRQoL).<br><br>To characterise the pharmacokinetics (PK) of AZD9291, AZ5104 and AZ7550 in subjects receiving AZD9291.<br><br>Safety Objective;Primary end point(s): Progression Free Survival (PFS) using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).;Timepoint(s) of evaluation of this end point: At baseline and every 6 weeks from randomization until progression.