Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs

Required: EGFR exon 19 deletion

EGFR-mutant (ex19del or L858R mutations)

Required: EGFR L858R

EGFR-mutant (ex19del or L858R mutations)

Required: EGFR C797X

Presence of C797X and absence of T790M mutations documented locally (as part of clinical practice) on a sample (blood or tissue) collected after progression on treatment with 3rd generation EGFR TKI.

Required: EGFR wild-type

Presence of C797X and absence of T790M mutations documented locally (as part of clinical practice) on a sample (blood or tissue) collected after progression on treatment with 3rd generation EGFR TKI.

Must have received: third-generation EGFR TKI

Disease progression on a 3rd generation EGFR TKI-based therapy (monotherapy or in combination) received at any prior line of treatment.

Cannot have received: EGFR-targeted TKI

Exception: within 7 days prior to the first dose of STX-241

EGFR-targeted TKI within 7 days prior to the first dose of STX-241.

Cannot have received: systemic anticancer therapy

Exception: within 28 days or 5 half-lives prior to the first dose of STX-241, whichever is the shortest, but with a minimum of 14 days in all circumstances

Any other systemic anticancer therapy within 28 days or 5 half-lives prior to the first dose of STX-241, whichever is the shortest, but with a minimum of 14 days in all circumstances.

Cannot have received: radiotherapy

Exception: to a large field or including a vital organ (including whole brain radiotherapy or stereotactic radiosurgery to brain) within 14 days before the first dose of STX-241

Radiotherapy to a large field or including a vital organ (including whole brain radiotherapy or stereotactic radiosurgery to brain) within 14 days before the first dose of STX-241.