A Phase II Study of Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select IIIA [T3N1, T4N0-1] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA) Big Ten Cancer Research Consortium BTCRC-LUN19-396
Circulating tumor DNA (ctDNA) is genetic material in the bloodstream that comes from the subject's tumor. The purpose of this study is to estimate how many people with measurable ctDNA in the blood at baseline have unmeasurable ctDNA after receiving 1 year of chemotherapy and atezolizumab. Other studies have shown there is a strong connection between having ctDNA in the blood and lung cancer returning. Researchers will test blood from participants five times throughout this study and look for ctDNA. The usual approach for patients who are not in a study is to receive chemotherapy after lung cancer surgery. The goal of chemotherapy is to kill any remaining cancer cells that may be left after surgery. This study will add a drug called atezolizumab to the usual chemotherapy drugs. Researchers think atezolizumab will also help kill any cancer cells that may be left after surgery. In this study chemotherapy and atezolizumab are given as infusions in the clinic once every three weeks. There will be tests, exams, and procedures that are part of subjects' regular care and for study purposes. There will be scans every 3 months to make sure the cancer hasn’t come back. Subjects will receive both chemotherapy and atezolizumab for the first 4 doses (about 2 months). After that, they will continue to receive just the atezolizumab for up to 1 year.
We are asking you to take part in this voluntary research study because you have early stage non-small cell lung cancer that has been completely removed by surgery.
Complete surgical resection of their NSCLC with negative margins
Surgery completed within 60 days prior to starting treatment
EGFR mutations and ALK re-arrangements
Prior chemotherapy, radiation therapy, or immunotherapy for lung cancer
Other active cancers
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor