Atezolizumab as Induction Therapy in Non-small Cell Lung Cancer (PRINCEPS)
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|ClinicalTrials.gov Identifier: NCT02994576|
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : August 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonsmall Cell Lung Cancer||Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm Phase 2 Study of Atezolizumab as Induction Therapy in Stage IB-IIIA Non N2 Resectable and Untreated Non-small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||December 20, 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||May 2021|
|Experimental: Stage IB(≥ 2 cm)-IIIA non N2, resectable and untreated NSCLC||
Atezolizumab, 1200 mg administered I.V. once
- The rate of patients without major toxicities or morbidities [ Time Frame: During the period defined as the start of treatment and 1 month after the surgery (2-month tolerance rate) ]
Major toxicities or morbidities: it will include
a) treatment toxicity leading to a delay of at least 15 days of the surgery, b) grade ≥ 3 toxicity occurring within 2 months after atezolizumab infusion, c) major postoperative morbidity and d) any death related to the experimental treatment and occurring in the period from the day of injection of atezolizumab to the 30 postoperative days. Patients that did not have surgery because of early progression will be considered as having major toxicities or morbidities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994576
|Contact: Benjamin BESSE, MD, PhD||0142114322 ext +firstname.lastname@example.org|
|Contact: Geraldine MARTINEAU, MD||0142115607 ext +email@example.com|
|Villejuif, Val De Marne, France, 94805|
|Contact: Geraldine MARTINEAU, MD 014225607 ext +33 firstname.lastname@example.org|