Phase 2
Completed N=659
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT02031458 ↗Enrolled (actual)
659
Serious AEs
42.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) — 26.2; 23.8; 27.0; 25.35 percentage of participants
Summary
This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) |
26.2; 23.8; 27.0; 25.35; 21.1; 17.4 | — |
| SECONDARY Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV) |
30.8; 24.6; 28.7; 26.6; 24.4; 19.4 | — |
| SECONDARY Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV |
20.0; 27.0; 30.4; 28.7; 16.3; 21.9 | — |
| SECONDARY Duration of Response (DOR) Assessed by IRF Per RECIST v1.1 |
NA; NA; 7.2; 7.2; 8.5; 8.4 | — |
| SECONDARY DOR as Assessed by INV Per RECIST v1.1 |
8.5; NA; 8.4; NA; 8.5; NA | — |
| SECONDARY DOR as Assessed by INV Per Modified RECIST |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1 |
5.5; 4.1; 4.2; 4.1; 5.6; 2.8 | — |
| SECONDARY PFS as Assessed by INV Per RECIST v1.1 |
7.1; 4.1; 4.2; 4.2; 7.6; 3.0 | — |
| SECONDARY PFS as Assessed by INV Per Modified RECIST |
7.1; 5.7; 6.3; 5.8; 7.9; 4.5 | — |
| SECONDARY Overall Survival : Percentage of Participants Without Event (Death) |
70.8; 70.5; 67.0; 68.8; 75.6; 69.2 | — |
| SECONDARY Overall Survival : Median Time to Event (Death) |
NA; NA; NA; NA; 14.0; NA | — |
| SECONDARY Percentage of Participants Without an Event (Death) at 6 Months |
79.2; 79.7; 75.1; 77.4; 83.9; 78.1 | — |
| SECONDARY Percentage of Participants Without an Event (Death) at 12 Months |
58.6; 61.5; 62.6; 61.3; 67.1; 59.3 | — |
| SECONDARY PFS: Percentage of Participants Alive and Progression Free at 6 Months |
57.4; 41.3; 42.1; 41.8; 58.6; 36.1 | — |
| SECONDARY PFS: Percentage of Participants Alive and Progression Free at 12 Months |
33.1; 27.8; 16.1; 23.1; 29.0; 22.7 | — |
| SECONDARY Time in Response (TIR) as Assessed by INV Per RECIST v1.1 |
0.033; 0.033; 0.033; 0.033 | — |
| SECONDARY TIR as Assessed by INV Per Modified RECIST |
0.033; 0.033; 0.033; 0.033 | — |
| SECONDARY TIR as Assessed by IRF Per RECIST v1.1 |
0.033; 0.033; 0.033; 0.033 | — |
| SECONDARY Atezolizumab Serum Concentrations |
0.285; 429.0; 299.0; 220.0; 155.0; 106.0 | — |
| SECONDARY Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status |
7.4; 3.5; 6.1; 4.8; 45.1; 36.0 | — |
| SECONDARY Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1 |
58.5; 68.0; 73.0; 70.5; 61.8; 73.7 | — |
| SECONDARY Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1 |
50.8; 63.1; 68.7; 65.8; 50.4; 68.8 | — |
| SECONDARY Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1 |
36.9; 56.6; 60.0; 58.2; 38.2; 61.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants greater than or equal to 18 years of age
- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
- PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
- Measurable disease, as defined by RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:
Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1
- Central nervous system (CNS) disease, including treated brain metastases
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted
- Active hepatitis B or hepatitis C
- Human Immunodeficiency virus (HIV) positive
- Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Data sourced from ClinicalTrials.gov (NCT02031458). 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. Informational only — not medical advice.