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 |
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Recruitment Status :
Active, not recruiting
First Posted : October 7, 2016
Last Update Posted : March 24, 2020
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 20, 2017 |
| Estimated Primary Completion Date : | April 16, 2020 |
| Estimated Study Completion Date : | October 31, 2024 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atezolizumab
Participants 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.
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Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: RO5541267, MPDL3280A |
Primary Outcome Measures :
- Percentage of Participants with Major Pathologic Response (MPR) [ Time Frame: After surgery (approximately 10 weeks) ]
Secondary Outcome Measures :
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: After surgery (approximately 10 weeks) ]
- 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 ]
- Percentage of Participants with Adverse Events [ Time Frame: From Baseline until 90 days after end of treatment (approximately 16.5 months overall) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927301
Locations
Show 21 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT02927301 |
| Other Study ID Numbers: |
ML39236 |
| First Posted: | October 7, 2016 Key Record Dates |
| Last Update Posted: | March 24, 2020 |
| Last Verified: | March 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Atezolizumab Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |