Atezolizumab as Induction Therapy in Non-small Cell Lung Cancer
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Based on the efficacy of immunotherapies in advanced disease with a reasonable safety
profile/tolerability we could hypothetisize that, immunotherapy should work best in the
situation of minimal residual disease, Two clinical trials are ongoing to test the role of
immunotherapeutic agents in the adjuvant setting: PEARLS trial, a randomized phase III trial
with anti-PD1 monoclonal antibody pembrolizumab (MK-3475 or pembrolizumab) versus placebo for
patients with early stage NSCLC after resection and completion of standard adjuvant therapy,
and the second randomized phase III trial (NCT02273375) will evaluate the efficacy of an
anti-PD-L1 (MEDI 4736) for a maximum of 12 months versus placebo as adjuvant therapy in
completed resected stage IB-IIIA NSCLC and completed standard ACT.
The role of immunotherapeutic approaches for NSCLC in the neoadjuvant setting is currently
unknown. However, based on the survival efficacy of immunotherapeutic strategies in advanced
NSCLC where the tumor has not been removed which could produce higher immunogenicity and
based on the efficacy of neoadjuvant treatments in NSCLC, we propose to test the safety and
efficacy of atezolizumab as neoadjuvant therapy in subjects diagnosed with stage I, II, or
IIIA (non N2) NSCLC and who are deemed suitable for surgical resection.
Clinical staging of NSCLC is based on computed tomography (CT) of the chest and upper
abdomen, brain CT or magnetic resonance imaging and 18F-FDG PETscan to rule out metastatic
disease and assess the potential for curative-intent resection. Adjuvant chemotherapy will be
performed according the standard clinical guidelines.