L19-IL2 immunotherapy and SABR in NSCLC patients

• Research type

  Research Study

• Full title

  Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer

• IRAS ID

  261785

• Contact name

  Crispin Hiley

• Contact email

  Crispin.Hiley@ucl.ac.uk

• Sponsor organisation

  Maastricht University Medical Centre

• Eudract number

  2018-002583-11

• Clinicaltrials.gov Identifier

  NCT03705403

• Duration of Study in the UK

  4 years, months, days

• Research summary

  It is a multicentre, randomised controlled open-label phase II clinical trial testing the hypothesis that a combination of SABR and immunocytokine L19-IL2 increases the progression-free survival in patients with limited (stage IV) metastatic NSCLC.

  The purpose of this scientific study is to verify whether immunotherapy (L19-IL2) after a standard treatment such as radiotherapy, fights the metastatic disease more efficiently than the current standard treatment alone.

  The Investigational Drug is L19-IL2.

  Patient population:
  - Oligometastatic patients with max. 5 metastases, amenable to SABR to all metastatic lesions
  - Poly-metastatic patients with 6 to 10 metastases, amenable to SABR to maximal 5 metastatic lesions, with either no previous treatment or following chemo- and/or immunotherapy first line or second line

  Patients with limited (stage IV) metastatic NSCLC (max 10 metastasis) will be randomised by minimisation in 2 arms: E-arm or C-arm

  Experimental arm:
  Oligo patients: SABR to all metastatic lesions, followed by administration of up to 6 cycles of the immunocytokine L19-IL2 (+Anti-PD(L)1 if SOC)
  Poly patients: SABR or conventional R to max 5 meta lesions, followed by admin of up to 6 cycles of the immunocytokine L-19IL2 + (Anti-PD(L)1 if SOC)

  Control Arm (C-arm):
  Oligo patients: SOC according to local protocols; generally, SABR to all metastatic lesions (+Anti-PD(L)1 if SOC)
  Poly patients: SOC according to local protocols; generally, SABR or Radiotherapy to preferably 5 metastatic lesions but at least 1 (+Anti-PD(L)1 if SOC)
  
  In both arms, after randomisation:
  - there will be a follow-up CT-scan and QOLQ to be completed every 6weeks during first year, in the second year every 8weeks if SOC, otherwise at least every 12weeks , for 1,5 y after randomisation

  After randomisation in C-arm and after study treatment in E-arm
  - Patient will receive conventional systemic therapy (OFF study)

  The study will be conducted in the oncology department of hospitals.

  When patient is randomized to the E-arm, patient may have to come 18 hospital visits more (spread over a period of 18 weeks) than the patients in the C-arm (30 visits).

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  20/NW/0313

• Date of REC Opinion

  17 Sep 2020

• REC opinion

  Further Information Favourable Opinion