Clinical Trial: NCT02927301 - My Cancer Genome

NCT02927301

Description:

This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02927301

Trial Eligibility

Document

Title

Brief Title: A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Official Title: A Phase II, 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

Clinical Trial IDs

ORG STUDY ID: ML39236
NCT ID: NCT02927301

Conditions

Non-Small Cell Lung Cancer

Interventions

Drug	Synonyms	Arms
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody	RO5541267, MPDL3280A	Atezolizumab

Purpose

Trial Arms

Name	Type	Description	Interventions
Atezolizumab	Experimental	Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of atezolizumab.	Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4
             (by size criteria, not by mediastinal invasion) NSCLC

          -  Adequate pulmonary and cardiac function

          -  Available biopsy of primary tumor with adequate samples

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by
             virtue of N3 disease

          -  Any prior therapy for lung cancer within 3 years.

          -  Prior treatment with anti-PD-1 or PD-L1 therapies

          -  History or risk of autoimmune disease

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Percentage of Participants With Major Pathologic Response (MPR)
Time Frame:	After surgery (approximately 10 weeks)
Safety Issue:
Description:	Major pathologic response (defined as ≤ 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.

Secondary Outcome Measures

Measure:	Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame:	After surgery (approximately 10 weeks)
Safety Issue:
Description:	Objective response rate is the proportion of participants who are objective responders (Complete Response and Partial Response are considered as responders, Stable Disease, Progressive Disease and Not Evaluable are considered as nonresponders) in the PD-L1 positive (TC123IC123) and negative (TC0IC0) groups.

Measure:	Percentage of Participants With Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants
Time Frame:	After surgery (approximately 10 weeks)
Safety Issue:
Description:	Major pathologic response (defined as ≤ 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.

Measure:	Percentage of Participants With Adverse Events
Time Frame:	From Baseline until 90 days after end of treatment (approximately 16.5 months overall)
Safety Issue:
Description:

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Genentech, Inc.

Last Updated

May 17, 2021

Clinical Trials /

A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)