CJDQ443B12301

• Research type

  Research Study

• Full title

  KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer

• IRAS ID

  1004433

• Contact name

  Esra Esencan

• Contact email

  esra.esencan@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2021-002605-10

• Clinicaltrials.gov Identifier

  NCT05132075

• Research summary

  The purpose of the study is to determine if JDQ443 is safe and effective for better controlling None Small Cell Lung Cancer (NSCLC), with KRAS G12C mutation, compared to docetaxel.
  JDQ443 is an oral drug that is called “targeted” medicine: this means that it targets particular processes which may not be working properly (called dysregulation) in the lung cancer cells in your body and which may be causing your disease. The dysregulation of KRAS by the mutation G12C in lung cancer cells is believed to make the cancer cells grow uncontrollably.
  Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung cancer. This anti-cancer medicine is a cytotoxic chemotherapy that is being compared with JDQ443 in this trial.
  Approximately 360 people with NSCLC, a subtype of lung cancer, with a specific mutation (changes in a gene) called KRAS G12C and who are 18 years old/or older are being invited to join this study. The study is being organised and funded by Novartis Pharma AG, and is being run by the medical staff in hospital oncology clinics. Patients have a 50% chance of receiving the study treatment JDQ443 or a 50% chance of receiving study treatment docetaxel.
  The study consists of a screening period (before starting study treatment, to find out if you meet the “entry criteria” for the study), a treatment period (while you are taking the study treatment), an end of treatment period (when you stop taking study treatment), and a follow-up period (after you have stopped taking study treatment). Patients will be in the study as long as their Study Doctor considers that they benefit from the study treatment, unless they decide to stop study treatment or the study is cancelled. During this time, they will need to visit the Study Doctor regularly, up to 6 times during the first 42 days (6 weeks, or 2 cycles) and then typically every 21 days (3 weeks, or 1 cycle) thereafter.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  22/WM/0120

• Date of REC Opinion

  14 Jul 2022

• REC opinion

  Further Information Favourable Opinion