Phase 2
N=181
A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02927301 ↗Enrolled (actual)
181
Serious AEs
34.8%
Results posted
May 2021
Primary outcome: Primary: Percentage of Participants With Major Pathologic Response (MPR) — 20.3 percentage of participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Major Pathologic Response (MPR) |
20.3 | <.0001 sig |
| SECONDARY Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for PD-L1-Positive Versus PD-L1-Negative Participants |
13.3; 1.9 | 0.0358 sig |
| SECONDARY Percentage of Participants With Major Pathologic Response for PD-L1-Positive Versus PD-L1-Negative Participants |
29.8; 13.5 | 0.0395 sig |
| SECONDARY Number of Participants With at Least One Adverse Event |
177 | — |
| SECONDARY Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load |
16.7; 9.1; 33.3 | — |
| SECONDARY Percentage of Participants With Major Pathologic Response (MPR) by Neoantigen Score |
19.4; 25.8 | — |
| SECONDARY Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: Gene Set Variation Analysis (GSVA) |
17.6; 35.3; 33.3 | — |
| SECONDARY Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: xCell Immune Score |
29.4; 23.5; 33.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02927301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.