N=~68
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the J&J Clinical Trial Finder
Key eligibility criteria†:
- Non-squamous NSCLC with completely resectable stage II-IIIB N2 disease
- Complete surgical resection of the primary NSCLC must be achievable
- ECOG PS 0 or 1
- No presence of primary driver mutations (ALK, MET, HER2, ROS1, NTRK, BRAF, RET, or KRAS), besides EGFR exon 19del or exon 21 L858R mutations
- No prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR TKI therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Primary outcome:
- MPR
Secondary outcomes:
- pCR
- Pathologic nodal downstaging at the time of surgery
- DCR
- AEs by severity
- Abnormalities in clinical laboratory parameters
*Soon to be recruiting. †Not a complete list of inclusion and exclusion criteria.
Ab, antibody; AE,
adverse event; ALK, anaplastic lymphoma kinase; BRAF, B-Raf proto-oncogene; CT, chemotherapy; DCR, disease control
rate; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; EGFRm,
EGFR mutated; HER2, human epidermal growth factor receptor 2; KRAS, Kirsten rat sarcoma viral oncogene homolog; MET,
mesenchymal epithelial transition; MPR, major pathologic response; NSCLC, non–small cell lung cancer; NTRK,
neurotrophic tyrosine receptor kinase; pCR, pathological complete response; RET, REarranged during
transfection; ROS1, proto-oncogene tyrosine-protein kinase ROS; TKI, tyrosine kinase inhibitor.