Comparison LOXO-292 to Platinum-Based and Pemetrexed +/- Pembrolizumab
Research type
Research Study
Full title
A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing LOXO-292 to Platinum-Pemetrexed Chemotherapy Plus Investigator’s Choice of Pembrolizumab in Patients with Advanced, Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer
IRAS ID
276269
Contact name
Alan James Lenox-Smith
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2019-001979-36
Duration of Study in the UK
5 years, 11 months, 2 days
Research summary
Lung cancer is the most common form of cancer and most lung cancers are specific type of lung cancer called Non-Small Cell Lung Cancer (NSCLC). Currently standard treatment for patients with NSCLC is typically a chemotherapy regimen that contains cisplatin or carboplatin. Approximately 20% to 30% of patients treated with the standard treatment have a marked decrease in their tumour size and have benefit for approximately 5 months. New advances have indicated that some patients may gain additional benefit by adding immunotherapy to the standard regimens. Additionally, some patients have specific changes to genes in their tumours that drive the growth of the tumour. One of these changes is to the RET gene. The change to the RET gene causes the body to make an abnormal RET protein, which can lead to uncontrolled cell growth and cancer. Changes in the RET gene are rare and only have been identified in approximately 2% of NSCLC patients.
LOXO-292 blocks the action of the abnormal RET proteins and may slow or stop the growth of the cancer. It may also help to shrink the cancer. In a phase 1 / 2 clinical trial, LOXO-292 demonstrated preliminary evidence of anti-tumour activity. A total of 68% (26/38) of patients had a marked reduction in their tumour size.
Study J2G-MC-JZJC is a randomised trial where both the investigators and participants know which treatment is being administered. It is a phase 3 trial which compares the experimental treatment (LOXO-292) to standard treatment (platinum based and pemetrexed therapy with or without pembrolizumab). The study will allow patients who do not benefit from the standard treatment to crossover and potentially receive LOXO-292.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0373
Date of REC Opinion
24 Feb 2020
REC opinion
Further Information Favourable Opinion