ew targeted therapy in relapsed EGFR-mutated lung cancer previously treated with EGFR-inhibitors

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; MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000307-10-DK
• Lead Sponsor: Oslo university hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-18
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

ADvancer lung cancer, egfr mut+, efter previous tretament with an egfr inhibitor
Ps 0-3
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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

PS 4

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy evaluation of AZD9291;Secondary Objective: Safety evaluation and translational aspects;Primary end point(s): Objective response rate assessed by RECIST 1.1;Timepoint(s) of evaluation of this end point: At baseline and every 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PFS, DoR, DCR and OS<br>Safety endpoints (CTCAE v4);Timepoint(s) of evaluation of this end point: At baseline and every 8 weeks