A2A-005 - iTeos - NSCLC - 6287/0001
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy.
IRAS ID
1005117
Contact name
Sally Ross
Contact email
Sponsor organisation
iTeos Belgium SA
Eudract number
2021-005487-22
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, multinational, Phase 2 study with 2 parts. Participants may be treated in Part 1 or Part 2, but not both. The study is looking to find a treatment for non-small cell lung cancer (NSCLC).
Lung cancer is the 2nd most prevalent tumour type worldwide, & has the highest mortality rate. There are 2 main classes of lung cancer: NSCLC which comprises about 85% of patients, & small cell lung cancer which comprises the remaining 15%.
In Part 1, the sponsor plans to include up to approx. 42 participants whose NSCLC continued to worsen despite standard treatments. Participants in Part 1 will receive inupadenant & carboplatin & pemetrexed. Data obtained from Part 1 will show if Inupadenant is safe & tolerable alongside carboplatin & pemetrexed. It will also help determine the recommended dose of inupadenant in combination with carboplatin & pemetrexed for Part 2.
In Part 2 of the study, approx.150 participants will be assigned randomly (by chance) to receive either inupadenant or a placebo (which looks like inupadenant, but has no active ingredients), in addition to the carboplatin & pemetrexed combination.
The study will also assess what happens to the study treatment once administered, how the body gets rid of it, & what effects the study treatment has on the body. The effects of the study treatment will be inspected in blood samples, tumour biopsies & by measuring changes in the size of tumours.
Within the UK, the research will be conducted at NHS Hospitals & private clinics/hospitals.
In both study parts, treatment periods are organised in cycles lasting 21 days. Depending on how many treatment cycles participants have & how well their cancer responds to study treatment, the total treatment period may last many months.
Participants will undergo physical exams, have vital signs checked, & other noninvasive procedures. Exams during the trial will include blood samples & may include several biopsies (most are optional).REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0503
Date of REC Opinion
26 Aug 2022
REC opinion
Further Information Favourable Opinion