Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

Prior treatment

• Subject has been exposed to any of the following prior therapies: •Prior treatment with docetaxel for NSCLC •Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, or autologous cell immunotherapy, •Treatment with an anti-cancer agent within 28 daysrior to GEN1046 administration.

Lab values

• Documentation of known EGFR sensitizing mutations, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET rearrangement, ALK gene rearrangements, highlevel MET amplification, or METex 14 skipping

• Subject must sign an informed consent form (ICF)
• Subject must be at least 18 years of age on the day of signing the ICF
• 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 -mAb for metastatic disease.
• 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 Eastern Cooperative Oncology Group (ECOG) performance status (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 protocol.