KontRASt-06
Research type
Research Study
Full title
KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation.
IRAS ID
1005789
Contact name
Esra Esencan
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-001088-29
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to determine if JDQ443 is safe and effective and if it can help people who have a type of lung cancer called non-small cell lung cancer (NSCLC), with a specific alteration in the DNA of the tumor cells called KRAS G12C mutation - that contributes to cancer growth.
JDQ443 is an oral drug called a “targeted” medicine: this means it targets particular processes which may not be working properly (called dysregulation) in lung cancer cells and which may contribute to NSCLC growth and dissemination. The dysregulation caused by the KRAS G12C mutation in lung cancer cells is believed to make the cancer cells grow uncontrollably. By acting on KRAS G12C, JDQ443 may be able to stop the growth of the cancer.
Approximately 120 participants with NSCLC whose tumors have a KRAS G12C mutation and who are 18 years or older are being invited to join this study.
Besides the marker KRAS G12C mutation, 2 other markers also found in cancer cells are required for participants to be eligible for this study: the presence of low levels of a protein called “programmed death receptor ligand 1 (PD-L1)” or the presence of an “STK11 mutation”. These 2 markers have been selected because prior studies showed that patients with NSCLC whose tumours have one of these 2 markers derived less benefit from treatment with immunotherapy - which is one of the standard treatments for patients with NSCLC.
The study consists of a pre-screening period (to test if the tumour has the characteristics required for participation in the study), a screening period (before starting study treatment, to find out if a participant meets all the “entry criteria” for the study), a treatment period (while the participant is receiving the study treatment), an end of treatment period (when study treatment is discontinued), and a follow-up period (after discontinuation of study treatment).REC name
Wales REC 2
REC reference
22/WA/0282
Date of REC Opinion
25 Nov 2022
REC opinion
Further Information Favourable Opinion