A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor - GEN1046 as mono and combination therapy in recurrent NSCLC (phase 2)

Genmab0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Genmab
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Subject must be at least 18 years of age.
•Subject has histologically or cytologically confirmed diagnosis of stage 4
•NSCLC with at least 1 prior line of systemic therapy containing an
•anti-PD-1/PD-L1 monoclonal antibody (mAb). Subjects must have demonstrated
•disease progression (PD) as defined by RECIST v1.1. For the subjects whose most
•recent anti-cancer therapy contained an anti-PD-1/PD-L1 mAb, their recent
•evidence of PD must be confirmed by a second assessment no less than 4 weeks
•from the date of the initial documented PD.
•Note: Subject must have received at least 2 doses of an approved anti
•PD-1/PD-L1 mAb approved in NSCLC.
•o Subject has progressed during or after treatment with 1 anti-PD-1/PD-L1 mAb
•administered either as monotherapy, or as SOC combination (subjects who have
•received only anti-PD-1/PD-L1 mAb monotherapy as first-line therapy, are
•eligible for this study if the investigator determines treatment with
•platinum-containing chemotherapy is not appropriate, in line with local
•treatment guidelines) or;
•o Subject has progressed during or after platinum doublet chemotherapy
•following an anti-PD-1/PD-L1 mAb or;
•o Subject has progressed during or after an anti-PD-1/PD-L1 following platinum
•doublet chemotherapy.
•Subject must have a tumor PD-L1 expression result available prior to C1D1
•demonstrating PD-L1 expression in >=1% of tumor cells as assessed by a sponsor
•designated central laboratory using the Dako PD-L1 IHC 22C3 pharmDx assay
•(TPS>=1%), or per site local assessment with the Dako PD-L1 IHC 22C3 pharmDx
•assay (TPS>=1%) or the VENTANA PD-L1 (SP263) assay (TC >=1%) adhering to the
•manufacturer*s instructions.
•Note: Local PD-L1 result needs to be performed on fresh tumor tissue (obtained
•within 3 months prior to enrollment and after failure/stop of last prior
•treatment) or, if not feasible, archival tissue (obtained within 12 months
•prior to enrollment).
•Subject must have measurable disease per RECIST v1.1 as assessed by the
•investigator.
•Subject must have ECOG PS <=1.
•Subject must have life expectancy of at least 3 months.
•Subject must have adequate organ and bone marrow function as described in the

排除标准

•Documentation of known EGFR sensitizing mutations, KRAS, RET, ROS1, BRAF
•mutations, NTRK gene infusions, RET rearrangement, ALK gene rearrangements,
•MET amplification, or METex 14 skipping. If documentation of mutation status is
•not available, for subjects with non-squamous histology or a mixed histology of
•non-squamous and squamous, a formalin-fixed, paraffin-embedded tumor tissue
•should be tested for biomarker panel analysis (which may include, but is not
•limited to, EGFR, ALK, ROS1, BRAF, KRAS mutations, RET rearrangement, or NTRK
•gene infusions, etc.). Subjects must not be randomized until biomarker status
•is available in source
•documentation at the site.
•Note: Subjects with tumors harboring such targetable mutations, gene
•rearrangements, or gene amplifications as described above may enroll in the
•trial, if such subjects have also received an approved targeted therapy for
•this indication assuming satisfactory fulfilment of all other eligibility
•criteria (especially, at least 1 prior line of systemic therapy
•containing an anti-PD-1/PD-L1 mAb for metastatic NSCLC disease).
•Subject has been exposed to any of the following prior therapies:
•o Prior treatment with docetaxel for NSCLC.
•o Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor
•vaccine, or autologous cell immunotherapy.
•o Treatment with an anti-cancer agent within 28 days prior to GEN1046
•administration.
•Subject discontinued treatment due to disease progression within the first 6
•weeks of a CPI-containing treatment.

研究者

发起方

Genmab

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