Lazcluze (lazertinib)

P2, N=68, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jul 2026 --> Mar 2027

Findings from the phase III WU-KONG28 trial indicate that the next-generation tyrosine kinase inhibitor sunvozertinib, an approved later-line option for patients with non-small cell lung cancer harboring EGFR exon 20 insertions, also looks effective up front, besting chemotherapy. Meanwhile, updated CHRYSALIS-2 data point to amivantamab combined with lazertinib as a new option for patients with atypical EGFR mutations, with initial efficacy translating to durable overall survival.

P3, N=393, Completed, Yuhan Corporation | Active, not recruiting --> Completed

Safety profiles varied: Osi+CT was associated with higher rates of grade ≥ 3 hematologic and gastrointestinal toxicities, while Ami+Laz was linked to higher rates of dermatologic events, infusion-related reactions, hypoalbuminemia, and peripheral edema. Despite the inherent limitations of indirect comparisons, these findings suggest that Osi+CT and Ami+Laz provide comparable survival benefits, while distinct toxicity profiles may influence therapeutic decision-making in conjunction with patients' clinical characteristics and preferences.

Inclusion of PTM costs did not alter the relative cost ranking calculated and findings were consistent across scenario analyses. Results from this descriptive cross-trial analysis indicated that total AE management costs were consistently estimated to be lower in patients receiving amivantamab (SC or IV) plus lazertinib compared with osimertinib plus platinum-based chemotherapy across both a Commercial and Medicare Advantage payer perspective.

P2, N=68, Not yet recruiting, Janssen Research & Development, LLC

P2, N=305, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

While third-generation tyrosine kinase inhibitors (TKIs) like osimertinib have long served as the frontline standard, the emergence of heterogeneous resistance mechanisms requires more robust therapeutic strategies. This review evaluates the clinical impact of the MARIPOSA trial, which demonstrated the superior efficacy of combining the bispecific antibody amivantamab with lazertinib...Furthermore, we explore the diversifying landscape of second-line interventions, including the rise of antibody-drug conjugates (ADCs) like Sac-TMT and patritumab-deruxtecan, dual PD-1/VEGF inhibitors, and novel fourth-generation TKIs. By integrating preclinical insights on drug-tolerant persister cells with late-phase clinical data, this article outlines a future for EGFR-mutant NSCLC management defined by precision sequencing and the proactive mitigation of molecular resistance.

Amivantamab-lazertinib reduces common resistance mechanisms (e.g., EGFR/MET) versus osimertinib, suggesting that this regimen is changing the underlying biology of EGFR-mutant disease, contributing to both first- and second-line long-term efficacy outcomes.

P2, N=150, Active, not recruiting, Se-Hoon Lee | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Mar 2026 --> Dec 2026

P3, N=776, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2026 --> Nov 2027

P3, N=1074, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2027 --> Nov 2027