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
Objective
Primary Objective: To estimate the percentage of patients with undetectable circulating tumor DNA (ctDNA) after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors ≥ 4cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have detectable ctDNA after surgery, but prior to adjuvant therapy.
Secondary Objectives: To estimate the percentage of patients with clearance of ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab in patients with stage I (tumors ≥ 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery.
To estimate the percentage of patients with clearance of ctDNA after 8 cycles (4 cycles of adjuvant chemotherapy + Atezolizumab plus 4 additional cycles of Atezolizumab) in patients with stage I (tumors ≥ 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery.
To estimate the percentage of patients with clearance of ctDNA after 12 cycles (4 cycles of adjuvant chemotherapy + Atezolizumab plus 8 additional cycles of Atezolizumab) in patients with stage I (tumors ≥ 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery.
To estimate the percentage of patients with clearance of ctDNA during or after adjuvant chemotherapy + Atezolizumab followed by Atezolizumab for up to 13 additional cycles who had no detectable ctDNA after surgery
To estimate the percentage of patients with clearance of ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors ≥ 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection, regardless of ctDNA status after surgery
To estimate the 1 year DFS in all patients treated on study
To estimate the 1 year DFS in patients with no detectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab who had detectable ctDNA after surgery.
To estimate the 1 year DFS in patients with detectable ctDNA after 1 year of adjuvant therapy on study
