Atezolizumab Immunotherapy in Patients With Advanced NSCLC
|ClinicalTrials.gov Identifier: NCT03102242|
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Induction Immunotherapy With Atezolizumab for Patients With Unresectable Stage IIIA and IIIB NSCLC Eligible for Chemoradiotherapy With Curative Intent.|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
Chemoradiotherapy: carboplatin AUC = 2 + paclitaxel 50 mg/m2 IV weekly x 6 weeks concurrent with radiation to a total dose of 60 Gy given in 2 Gy fractions daily M-F x 30 fractions
Consolidation chemotherapy: Carboplatin AUC = 6 + paclitaxel 200 mg/m2 IV q 21 days x 2 cycles beginning 3-5 weeks after completion of radiation.
Adjuvant immunotherapy: atezolizumab 1200 mg IV q 21 days to complete one year of therapy (from start of induction).
Single arm phase II trial of induction immunotherapy with anti-PD-L1 for patients with unresectable stage III NSCLC and PS 0-1.
- Disease control rate (DCR) after 12 weeks induction [ Time Frame: 12 weeks ]The primary objective of this single arm phase II trial is to determine whether neoadjuvant and adjuvant anti-PD-L1 therapy bracketing standard chemoradiation therapy and consolidation therapy is worthy of further investigation. The primary endpoint will be the disease control rate (DCR) after 12 weeks induction immunotherapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102242
|Contact: Ed Habermehlfirstname.lastname@example.org|
|Contact: Trini Ajazi||617-732-8727|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|United States, New York|
|SUNY Upstate Medical University||Recruiting|
|Syracuse, New York, United States, 13210|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Study Chair:||Helen Ross, MD||Mayo Clinic|
|Principal Investigator:||Monica Bertagnolli, MD||Alliance Foundation Trials|