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Protocol Summary


Protocol No.
PSCI-20-102
Prinicipal Investigator
Ma, Patrick
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
BTCRC-LUN19-396
Title
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
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center