Phase II study INC280 in non small cell lung cancer

• Research type

  Research Study

• Full title

  A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1≥ 50%

• IRAS ID

  272925

• Contact name

  Ortal Bar-Ziv

• Contact email

  ortal.bar_ziv@novartis.com

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2019-002660-27

• Clinicaltrials.gov Identifier

  NCT04139317

• Duration of Study in the UK

  0 years, 7 months, 26 days

• Research summary

  This is a randomized, open label, multicentre, phase II study evaluating the efficacy and safety of capmatinib plus pembrolizumab compared to pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer.
  The study will enrol approximately 96 subjects in a ratio of 2:1 (capmatinib plus pembrolizumab vs pembrolizumab alone). A randomized trial can eliminate bias in treatment assignment.

  The randomization 2:1 also increases the chances for subjects to receive the innovative combination of immunotherapy and immunomodulatory agent, which exhibits preclinical/clinical synergistic effect with immunotherapy. It will also allow for increased chance to detect adverse events with the capmatinib and pembrolizumab combination.

  Study will be stratified by histology (squamous vs non-squamous NSCLC). The stratification factor has been selected to balance potential predictive and/or prognostic factors between the two arms:
  Although anti-PD-1/PD-L1 activity is observed in both squamous and non-squamous histology, the magnitude of benefit and the absolute outcomes may differ slightly in the two histology's therefore randomization is stratified based on disease histology.
  The safety and efficacy will be measured by looking at how long patients respond to the treatment without their cancer progressing and the overall survival of all patients. Additional objectives of the study are to understand how the
  mechanism of the response works by measuring how quickly the drugs are absorbed and what molecules are involved in the response. Patients will be treated for a maximum of 35 cycles (maximum treatment duration of pembrolizumab) unless they stop treatment due to progression or dose-limiting toxicities.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  19/SC/0600

• Date of REC Opinion

  3 Dec 2019

• REC opinion

  Favourable Opinion