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Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Anti-cancer Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor

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2e lijn na chemo-immuno


Erasmus MC




Patients With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor


A prospective randomized controlled trial comparing standard treatment with ALK inhibitor alectinib to dose adjusted alectinib based on therapeutic drug monitoring. Patients will be stratified based on prior treatment

Key outcome parameters



Key inclusion criteria

Inclusion criteria:

  • Subject must have 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
  • Patients must have received at least 2 doses of an approved anti-PD-1/PD-L1 mAb approved in NSCLC
  • Progression during or after treatment with 1 anti-PD-1/PD-L1 mAb administered either as monotherapy, or as SOC combination
  • Progression during or after platinum doublet chemotherapy following an anti-PD-1/PD-L1 mAb
  • Progression during or after an anti-PD-1/PD-L1 mAb following platinum doublet chemotherapy
  • Subject must have PD-L1 tumor expression score of TPS ≥1% assessed by a central laboratory during screening
  • ECOG 0-1 perfomance status

Key exclusion criteria

Exclusion criteria:

  • Documentation of known EGFR, ROS1, or ALK mutations or gene rearrangements
  • 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 days prior to GEN1046 administration
    • Any investigational agent for the treatment of stage 4 NSCLC
    • Prior treatment with live, attenuated vaccines within 30 days prior to initiation of GEN1046
    • Radiotherapy within 14 days prior to first GEN1046 administration
    • Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone >10 mg daily or a cumulative dose >150 mg prednisone within 14 days before the first GEN1046
    • Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 4 weeks prior to first GEN1046 administration or being
      chronically transfusion dependent
    • Subject received their last dose of anti-PD-1/PD-L1 mAb >250 days prior to enrollment in this trial

All subjects should undergo a CT scan or MRI of the brain to document new or existing central nervous system (CNS) lesions. Subjects with history of intracerebral arteriovenous malformation, cerebral aneurysm, progressive brain metastases, spinal cord compression (from disease), or stroke will be excluded.

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