ADEPPT
Research type
Research Study
Full title
A multicentre, single-arm phase II trial of adagrasib in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status
IRAS ID
1006788
Contact name
Monika Hoerrmann
Contact email
Sponsor organisation
ETOP IBCSG Partners Foundation
Eudract number
2022-002736-31
Clinicaltrials.gov Identifier
Research summary
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. Several factors can cause NSCLC, one of which is a change in a gene called 'KRAS'.
For the initial treatment, there are no specific therapy options for patients with KRAS-positive lung cancer. The standard therapy for these patients is chemotherapy or immunotherapy (or a combination of both).
Patients whose lung cancer has stopped responding to chemotherapy or immunotherapy (or a combination of both) may receive treatment so-called KRAS-targeted treatment, an oral drug that blocks KRAS.
In the ADEPPT study, we are testing a new KRAS-targeted treatment called adagrasib. We want to find out if adagrasib is effective to stop or slow the growth of KRAS-positive lung cancer.
The study aims to include patients who are elderly (aged 70 years or older) or have poor performance status. Performance status is a measure of how well a person is able to carry on daily activities while living with cancer. Patients who are unwell because of their lung cancer, or who have other illnesses may have “poor performance status”.
Being elderly or having poor performance status usually means that the option to take part in a clinical study is limited. The ADEPPT study is now specifically including these patients.
• Group 1: Patients who are elderly (aged 70 years or older) who have good performance status
• Group 2: Patients aged 18 years or older (including elderly patients) who have poor performance status.
For both groups, treatment in the ADEPPT study consists of adagrasib, 600 mg orally, twice daily.
The treatment continues as long as the lung cancer remains stable. Patients may stop the treatment earlier if they experience side effects that are not tolerable.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0406
Date of REC Opinion
18 Jan 2024
REC opinion
Further Information Favourable Opinion