Phase 3 Study of OSE2101 Therapeutic Cancer Vaccine in NSCLC with Secondary Resistance to ICI
Research type
Research Study
Full title
A randomized, open-label, phase 3 trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to Immune Checkpoint Inhibitors (ICI) - ARTEMIA study
IRAS ID
1009759
Contact name
Lucie Begert
Contact email
Sponsor organisation
OSE Immunotherapeutics
Research summary
This is a Phase 3 open label study, where participants will be enrolled into 2 arms (randomization 2:1):
Experimental Arm A withOSE2101 monotherapy, or Control Arm B SoC with docetaxel monotherapy and where they will receive either OSE2101 or Docetaxel.
The participants will be selected at random. That means that neither the study doctor, or participant can choose the treatment that will be allocated.
This study will be conducted in approx 363 male and female participants who have Non-Small Cell Lung Cancer (NSCLC) with metastasis (excluding brain metastasis). The study is divided into four periods: Pre-screening, Screening, Treatment and Follow-up.
The screening period is from 2 wks up to 4 wks, the treatment period will last on average 24 wks.
Participation in the study for the screening and treatment periods is estimated to be 28 wks.
Participants will complete a pre-screening consent form, which will undergo a screening examination carried out by a study doctor to assess eligibility to participate in the study.
If participants agreed to take part, they will receive repeat administrations of the study medicine called a cycle. OSE2101 will be administered every three wks for six cycles, then every eight wks for the remainder of year one, finally every twelve wks until the end of second year. The treatment that participants will receive is OSE2101 or docetaxel and will continue as long as they are doing well and for a max of 24 mths. Beyond 24 mths, OSE2101 may be continued with justification of the investigator and after Sponsor’s agreement.
Follow-up of the study will start after participant’s study treatment has finished. Participants will be contacted by the study team every 3 mths to collect information on their state of health and subsequent treatment for their disease and tumour control since the end of study.
During the course of the study, participants will undergo a number of different procedures including imaging/MRIs, blood sampling, ECGs.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0171
Date of REC Opinion
14 Aug 2024
REC opinion
Further Information Favourable Opinion