Recruiting |Phase III
A Phase III, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy and Safety of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Patients With Stage IB, II, IIIA, or Selected IIIB Resectable and Untreated Non-Small Cell Lung Cancer
To evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab in combination with platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in patients with resectable non-small cell lung cancer.
- Study agents: Atezolizumab or placebo
- Platinum–based chemotherapy (chemotherapy is per investigator choice)
- Quality of Life questionnaires
- ARM A: Atezolizumab plus Platinum-based chemotherapy for 4 cycles
- ARM B: Placebo plus Platinum-based chemotherapy for 4 cycles
- Then unblinded and may receive Atezolizumab for 16 cycles
Key Participation Requirements:
Male or Female
19 years and older
Stage II, IIIA or IIIB (T3N2 only) Non-small cell lung cancer
ECOG performance status 0 or 1.
Pathologically squamous or non-squamous histology.
Evaluation by the attending surgeon and medical oncologist to verify eligibility for RO resection.
Adequate pulmonary function.
Adequate cardiac function.
Adequate hematologic and end-organ function.
No active autoimmune diseases or deficiency.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Methodist Health System Trial Code:
For more information, visit the U.S. National Library of Medicine clinical trial database.