Table of Contents
- Clinical trial overview
- Who the study is for
- Study design and treatment groups
- What the trial is trying to find out
- Main outcome being measured
- Key points for patients
Clinical trial overview
This study is an interventional trial, which means people are assigned to receive a treatment being tested.[1] It is testing HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST SEZ6, CONJUGATED TO (2S)-2-(2-BROMOACETAMIDO)-N-[(2S)-1-({3-[(7S)-7-ETHYL-7-HYDROXY-8,11-DIOXO-7,8,11,13-TETRAHYDRO-2H,10H-[1,3]DIOXOLO[4,5-G]PYRANO[3′,4′:6,7]INDOLIZINO[1,2-B]QUINOLIN-14-YL]BICYCLO[1.1.1]PENTAN-1-YL}AMINO)-1-OXOPROPAN-2-YL]-3-METHYLBUTANAMIDE in combination with atezolizumab, compared with standard of care as first-line treatment for extensive-stage small cell lung cancer.[1]
The trial is Phase 2 and has an enrollment target of 180 participants.[1] Its status is listed as Authorised.[1]
Who the study is for
The study is for people with previously untreated extensive-stage small cell lung cancer.[1] “Previously untreated” means the person has not yet had treatment for this cancer.[1] “Extensive-stage” means the cancer has spread widely.[1]
Study design and treatment groups
The trial compares two approaches: HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST SEZ6, CONJUGATED TO (2S)-2-(2-BROMOACETAMIDO)-N-[(2S)-1-({3-[(7S)-7-ETHYL-7-HYDROXY-8,11-DIOXO-7,8,11,13-TETRAHYDRO-2H,10H-[1,3]DIOXOLO[4,5-G]PYRANO[3′,4′:6,7]INDOLIZINO[1,2-B]QUINOLIN-14-YL]BICYCLO[1.1.1]PENTAN-1-YL}AMINO)-1-OXOPROPAN-2-YL]-3-METHYLBUTANAMIDE plus atezolizumab, and standard of care treatment.[1] The standard treatment listed in the trial includes carboplatin and etoposide, with atezolizumab also shown in the study treatment list.[1]
What the trial is trying to find out
The brief summary says the study is designed to evaluate safety and tolerability, meaning how safe the treatment is and how well people can handle it.[1] It also aims to optimize and select the recommended Phase 3 dose, which is the dose chosen for testing in a larger later study.[1] A third goal is to evaluate efficacy, meaning whether the treatment helps against the cancer.[1]
Main outcome being measured
The main outcome is progression-free survival (PFS), measured by investigator assessment using RECIST v1.1.[1] PFS is the amount of time people live without the cancer getting worse.[1] RECIST v1.1 is a standard set of rules doctors use to judge tumor changes on scans.[1]
Key points for patients
This is a study in small cell lung cancer, not in many different cancer types.[1]
The study is for people who have not yet received treatment for this cancer.[1]
Researchers are looking at both the study treatment and standard care to see which approach works better.[1]
The main focus is on whether the treatment can delay the cancer from getting worse.[1]
The trial is still in the research stage, so the results are not yet known.[1]
