The purpose of this study is to determine if IO102 combined with pembrolizumab with or without chemotherapy is safe tolerable and effective in the treatment of Non-small Cell Lung Carcinoma (NSCLC). The hypothesis is that IO102 will improve the objective response rate (ORR) in patients with metastatic NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
test immunotherapy
anti-PD-1 immunotherapy
chemotherapy
Thoraxklinik Heidelberg gGmbH
Heidelberg, Community of Heidelberg, Germany
PIUS Hospital Oldenburg
Oldenburg, Germany
Stichting Het Nederlands Kanker Instituut
Amsterdam, Community of Amsterdam, Netherlands
Phase 1 (safety run-in)
Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: One cycle i.e. 3 weeks
Phase 2 (efficacy)
Objective Response Rate (ORR) evaluated by RECIST 1.1 and defined as the rate of complete response (CR) + partial response (PR)
Time frame: From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years)
ORR
by baseline PD-L1 expression
Time frame: From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
chemotherapy
Servicio de Oncología-El médico del Virgen de la Victoria
Málaga, Andalusia, Spain
Insituto Oncologico Dr Rosell. Hospital Universitario Quiron Dexeus
Barcelona, Catalonia, Spain
Hospital Universitario de Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, Spain
Hospital Clinico Universitario de València
Valencia, Horta de València, Spain
Hospital Universitario 12 Octubre
Madrid, Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Spain
...and 3 more locations