Clinical Trials /

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

NCT02927301

Description:

This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy will consist of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy will consist of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery will enter a surveillance period, which consists of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants will be 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

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

DrugSynonymsArms
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibodyRO5541267, MPDL3280AAtezolizumab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
AtezolizumabExperimentalParticipants will first receive two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrate clinical benefit will be 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:

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:
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 12 weeks on study
Safety Issue:
Description:
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:Recruiting
Lead Sponsor:Genentech, Inc.

Last Updated