CNMP EGFR mutado. A favor de no hacer secuenciación

APPLE: Trial Design

Randomized, open-label, multicenter, phase II trial

Advanced NSCLC

Common

mEGFR

Treatment naïve

PS 0-2

Stable BM

Gefitinib*

Until cfDNA

PD (T790M+)

1:1:

Osimertinib until

RECIST PD

Rebiopsy

At PD by

RECIST

(optional)

ARM C

ARM A

Osimertinib

until

RECIST PD

Rebiopsy

At PD by

RECIST

(optional)

Primary End Point: PFS rate at 18 months

Gefitinib

Until RECIST

Osimertinib

until

RECIST PD

Rebiopsy

At PD by

RECIST

(optional)

(cfDNA by COBAS every 4 weeks + CT-scan brain-thorax-abdominal / 8 weeks all arms

*In case of RECIST progression without T790M+, patients will be switched

ARM B

Stratification:

-Del19 vs. L858R

Initial T790M

+ / -

-BM + / -

N=156