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+, mutated epidermal growth factor receptor including exon 19del or exon 21 L858R; ILD, interstitial lung disease; IV, intravenous; MET, mesenchymal epithelial transition factor; NSCLC; non–small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PO, orally; R, randomized; RECIST, Response Evaluation Criteria In Solid Tumors; SC, subcutaneous; TKI, tyrosine kinase inhibitor; TTTD, time to treatment discontinuation; TTNT, time to next therapy; TTSP, time to symptomatic progression; Q3W, every 3 weeks; Q4W, every 4 weeks; VTE, venous thromboembolism.