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

AZD9291, an irreversible EGFR-TKI, in relapsed EGFR-mutated non-small cell lung cancer patients previously treated with an EGFR-TKI, coupled to extensive translational studies. - TREM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000307-10-NO

Enrollment

150

Registered

2015-03-23

Start date

2015-05-27

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Locally advanced or metastatic non-small cell lung cancer where disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy

Interventions

Product Name: AZD9291 80 mg film-coated tablet Product Code: AZD9291 Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary end point(s): PFS, DoR, DCR and OS Safety endpoints (CTCAE v4);Timepoint(s) of evaluation of this end point: At baseline and every 8 weeks	—

Countries

Denmark, Finland, Lithuania, Norway, Sweden

Contacts

Public ContactClinical Trial Unit

Oslo university hospital

ot.brustugun@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026