A 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


Type carcinoma: NSCLC zonder mutatie
Stadium: IV
Mutatie: -
Lijn: 2de lijn na chemo-immuno
Site: Erasmus MC




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. Note: Subject must have received at least 2 doses of an approved anti-PD-1/PD-L1
mAb approved in NSCLC.

  • Subject has progressed during or after treatment with 1 anti-PD-1/PD-L1 mAb
    administered either as monotherapy, or as SOC combination.
  • Subject has progressed during or after platinum doublet chemotherapy following an
    anti-PD-1/PD-L1 mAb.
  • Subject has progressed 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


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
    • 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

    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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