N=~480
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Key eligibility criteria*:
- Locally advanced or metastatic treatment-naive exon 19 deletion or exon 21 L858R EGFRm NSCLC
- ≥1 measurable lesion per RECIST v1.1
- ECOG PS 0 or 1
- No history of ILD
- No major surgery or significant traumatic injury within 4 weeks before the first dose and no planned surgery while on study
- No uncontrolled tumor-related pain
- No prior investigational treatment that has not been cleared or within 12 months prior to first dose
- No prior or concurrent second malignancy (other than the disease under study), which natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Primary outcome:
- PFS
Secondary outcomes:
- Dose reductions, dose interruptions, and dose discontinuations
- VTEs
- Dermatologic AEs
- AEs by severity
- OS
- ORR
- DOR
- CBR
- TTTD
- TTNT
- TTSP
*Not a complete list of inclusion and exclusion criteria.
Ab, antibody; AE, adverse event; CBR, clinical benefit
rate; CT, chemotherapy; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance
status; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutated; ILD,
interstitial lung disease; IV, intravenous; MET, mesenchymal epithelial transition; NSCLC, non–small cell lung
cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PO, orally; Q3W, every 3
weeks; Q4W, every 4 weeks; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SC, subcutaneous;
TKI, tyrosine kinase inhibitor; TTTD, time to treatment discontinuation; TTNT, time to next therapy; TTSP, time to
symptomatic progression; VTE, venous thromboembolism.