Combination of Atezolizumab With Dendritic Cell Vaccine in Patients With Lung Cancer
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study,
of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in
extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites
will include patients in this study.
Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab
for four 21-day cycles (induction phase), followed by a maintenance phase during which they
will receive the dendritic cell vaccine (6 doses maximum) in combination with atezolizumab
until they had unacceptable toxic effects, disease progression according to Response
Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit.
The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both
in the intention-to-treat population. Secondary Outcome Measures include: Duration of
clinical benefit (DCB), Overall survival (OS) and Overall response rate (ORR)
The translational substudy will include:
Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA
expression, Work Environmental Scale (WES) analysis, and flow cytometry in pretreatment fresh
tumor tissue.
The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA
analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Instituto Oncológico Dr Rosell
Collaborators:
Fundacion Clinic per a la Recerca Biomédica Roche Pharma AG