B8011011 - Umbrella Study of Sasanlimab in Participants with NSCLC

• Research type

  Research Study

• Full title

  A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

• IRAS ID

  290969

• Contact name

  Alastair P. N. Greystoke

• Contact email

  alastair.greystoke@nhs.net

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2020-002829-28

• Clinicaltrials.gov Identifier

  NCT04585815

• Clinicaltrials.gov Identifier

  148021, IND

• Duration of Study in the UK

  3 years, 3 months, 25 days

• Research summary

  This is a Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC);

  Phase 2, Sub-Study A of this study will further evaluate the safety and anti-tumour activity with the recommended dose for the combination determined in phase 1b. Only Phase 2 - Sub-Study A, will be completed in the UK.

  The purpose of this study is to learn about the effects of the study drugs, sasanlimab, encorafenib and binimetinib, when given as a combination treatment for Non-Small Cell lung cancer. Sasanlimab, encorafenib and binimetinib are study drugs for this study.

  There will be about 62 people, aged 18 years old and above, taking part in this study in phase 2. The study is being done at about 30 different study sites in about 8 countries. The study will use competitive enrolment. This means that when a certain number of participants have enrolled in the study from all study sites combined, no one else will be allowed to participate.

  3 dose levels of the combinations will be available as follows:

  (a) Sasanlimab 300mg subcutaneously (injection) every 4 weeks + Encorafenib 300mg one daily + Binimetinib 30mg twice daily
  (b) Sasanlimab 300mg subcutaneously every 4 weeks + Encorafenib 300mg once daily + Binimetinib 45mg twice daily
  (c) Sasanlimab 300mg subcutaneously every 4 weeks + Encorafenib 450mg once daily + Binimetinib 45mg twice daily

  The main objective of this Phase 2 study is to assess the durable objective response rate of sasanlimab in combination with encorafenib and binimetinib. The main endpoint is durable objective response, defined as the proportion of
  participants in the analysis population with confirmed complete response or partial response lasting for at least 10 months, from the date of first complete response or partial response, as assessed by the investigator using RECIST v1.1.
  

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0108

• Date of REC Opinion

  8 Apr 2021

• REC opinion

  Further Information Favourable Opinion