N=~520
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Key eligibility criteria*:
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- No history of ILD or clinically significant CVD
- No symptomatic CNS metastases
Cohorts 1, 3, 3b, 5, 6, 7
- EGFR exon19del or exon 21 L858R mutation
- ≥1 measurable lesion (RECIST v1.1)
Cohort 2
- EGFR exon20ins
Primary outcomes:
Cohorts 1–3, 5–7
- ORR by INV
Cohort 4
- Incidence and severity of AEs
- Incidence and severity of abnormal clinical laboratory values
Secondary outcomes†:
Cohorts 1–3, 5–7
- Incidence and severity of AEs
- ORR by ICR
- DOR by INV
- TTR by INV
- PFS
- CBR
- OS
Cohort 4
- TASQ-SC
- TASQ-IV
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of
secondary outcomes.
1L, first line; 2L, second line; Ab, antibody; AE, adverse event; AUC, area under the
concentration-time curve; CBR; clinical benefit rate; CNS, central nervous system; CVD, cardiovascular disease; del,
deletion; DOR, duration of response; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor
receptor mutated; ICR, independent central review; ILD, interstitial lung disease; INV, investigator assessment; in,
insertion; IV, intravenous; MET, mesenchymal epithelial transition; NSCLC, non–small cell lung cancer; ORR,
objective response rate; OS, overall survival; PFS, progression-free survival; PO, orally; QD, daily; QW, weekly;
Q2W, every other week; Q3W, every third week; Q4W, every fourth week; RECIST v1.1, Response Evaluation Criteria in
Solid Tumors version 1.1; SC, subcutaneous; TASQ, therapy administration satisfaction questionnaire; TKI, tyrosine
kinase inhibitor; TTR, time to response.