GEN1046 monotherapy or combined with anti-cancer therapy in NSCLC pts

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1004314

• Contact name

  Charlotte Maretti

• Contact email

  cmi@genmab.com

• Sponsor organisation

  Genmab A/S

• Eudract number

  2021-001928-17

• Research summary

  The trial drugs are experimental drugs. This means that they have not yet been approved to treat NSCLC. The trial drugs used in this trial are called GEN1046 (DuoBody®-PD-L1x4-1BB) and Keytruda (Pembrolizumab). In this trial, GEN1046 is being tested as single treatment or in combination with Pembrolizumab to treat NSCLC.

  Before the start of this trial, at least 240 patients have been treated with GEN1046 as single treatment.
  In this trial, Genmab wants to find out how well the trial drugs works against NSCLC both as single treatment and in combination with Pembrolizumab. The other drug treatments will be administered as per the local prescribing rules in the UK. Genmab also wants to learn more about the potential side effects patients may get when they are treated with GEN1046 as single treatment or in combination with Pembrolizumab to treat NSCLC.

  The results of this trial may be used for further development of GEN1046. They can also be used to get the trial drug approved for cancer treatment.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  21/NE/0223

• Date of REC Opinion

  21 Dec 2021

• REC opinion

  Further Information Unfavourable Opinion