Libtayo (cemiplimab-rwlc)

P2, N=66, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting

Eligible patients have postoperative ctDNA positivity in the absence of radiographic recurrence and are allocated to one of three treatment arms: cemiplimab monotherapy; cemiplimab plus fianlimab (a lymphocyte activation gene-3 inhibitor); or cemiplimab plus REGN7075 (an EGFR×CD28 costimulatory bispecific antibody). Arms 2 and 3 use single-stage phase II designs, whereas Arm 1 follows a Simon two-stage design with early futility stopping. The study integrates comprehensive correlative analyses to characterize mechanisms of response and resistance.Clinical trial registration: The http://www.clinicaltrials.gov identifier is NCT07058012.

P2, N=136, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Recruiting --> Active, not recruiting

P2, N=135, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting --> Recruiting

This first-in-human study demonstrates that IT or IV VV1 administration had an acceptable safety profile as monotherapy and IV in combination with avelumab. There is preliminary antitumor activity. IT VV1 plus cemiplimab is now showing promise in the neoadjuvant setting.

In contrast, the same regimen showed inferior OS relative to many comparators (HR range for comparators vs. toripalimab plus chemotherapy: 0.47-0.65) and had the lowest OS ranking in SQ-NSCLC (SUCRA = 0.09). In the PD-L1 < 1% subgroup, nivolumab plus ipilimumab demonstrated a trend toward better OS compared with pembrolizumab plus chemotherapy (HR = 0.59) and ranked as the best regimen for SQ-NSCLC (SUCRA = 0.83), whereas pembrolizumab plus chemotherapy provided the greatest OS benefit for non-SQ-NSCLC (SUCRA = 0.90). In the PD-L1 ≥ 50% subgroup, atezolizumab plus chemotherapy ranked second for OS benefit in SQ-NSCLC but was the least effective combination in non-SQ-NSCLC; conversely, cemiplimab plus chemotherapy was the least effective combination in SQ-NSCLC but ranked second in non-SQ-NSCLC. The efficacy of individual first-line ICI regimens appear to vary by histological subtype across PD-L1 expression levels. These findings suggest that PD-L1 status alone might not be sufficient to guide treatment selection, and that histological subtype could be considered in clinical decision-making for advanced NSCLC.

P1/2, N=95, Completed, SillaJen, Inc. | Active, not recruiting --> Completed | Phase classification: P1b/2a --> P1/2

P1/2, N=30, Not yet recruiting, Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

P2, N=39, Recruiting, University of Chicago | Not yet recruiting --> Recruiting

P1, N=60, Not yet recruiting, Memorial Sloan Kettering Cancer Center

With 5-year follow-up, cemiplimab plus chemotherapy continues to show durable long-term efficacy benefits versus chemotherapy with consistent safety profile, as first-line therapy for advanced NSCLC.

P1, N=30, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Jun 2026 --> Dec 2026