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

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ClinicalTrials.gov Identifier: NCT02927301
Recruitment Status : Active, not recruiting
First Posted : October 7, 2016
Results First Posted : May 17, 2021
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 7, 2016
Results First Submitted Date  ICMJE April 23, 2021
Results First Posted Date  ICMJE May 17, 2021
Last Update Posted Date May 17, 2021
Actual Study Start Date  ICMJE April 20, 2017
Actual Primary Completion Date May 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2021)
Percentage of Participants With Major Pathologic Response (MPR) [ Time Frame: After surgery (approximately 10 weeks) ]
Major pathologic response (defined as ≤ 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
Percentage of Participants with Major Pathologic Response Based on Surgical Resection According to Criteria from Hellmann and Colleagues (2014) [ Time Frame: After surgery (approximately 10 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2021)
  • Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: After surgery (approximately 10 weeks) ]
    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.
  • 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) ]
    Major pathologic response (defined as ≤ 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.
  • Percentage of Participants With Adverse Events [ Time Frame: From Baseline until 90 days after end of treatment (approximately 16.5 months overall) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: After surgery (approximately 10 weeks) ]
  • Percentage of Participants with Objective Response According to RECIST Version 1.1 in Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants Based on Tumor Biomarkers [ Time Frame: After 12 weeks on study ]
  • Percentage of Participants With Adverse Events [ Time Frame: From Baseline until 90 days after end of treatment (approximately 16.5 months overall) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: RO5541267, MPDL3280A
Study Arms  ICMJE Experimental: Atezolizumab
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.
Intervention: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 23, 2021)
181
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2016)
180
Estimated Study Completion Date  ICMJE May 3, 2025
Actual Primary Completion Date May 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02927301
Other Study ID Numbers  ICMJE ML39236
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP