Phase 3
N=572
A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02409342 ↗Enrolled (actual)
572
Serious AEs
31.7%
Results posted
Feb 2021
Primary outcome: Primary: Overall Survival (OS) in the TC3 or IC3-WT Populations — 13.1; 20.2 Months — p=0.0106
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody (Drug); Carboplatin (Drug); Cisplatin (Drug); Gemcitabine (Drug); Pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) in the TC3 or IC3-WT Populations |
13.1; 20.2 | 0.0106 sig |
| PRIMARY Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations |
16.1; 19.9; 14.7; 18.9 | 0.3091 |
| SECONDARY Progression-free Survival (PFS) in the TC3 or IC3-WT Populations |
5.0; 8.1 | 0.0070 sig |
| SECONDARY Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations |
5.5; 7.3; 5.6; 5.8 | 0.0004 sig |
| SECONDARY Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations |
28.6; 38.3 | — |
| SECONDARY Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations |
32.1; 33.7; 32.1; 31.4 | — |
| SECONDARY Duration of Response (DOR) in the TC3 or IC3-WT Populations |
6.7; NA | — |
| SECONDARY Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations |
5.8; 38.9; 5.7; 26.3 | — |
| SECONDARY Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations |
50.64; 64.90 | — |
| SECONDARY Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations |
24.79; 45.49 | — |
| SECONDARY Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations |
58.65; 63.39; 54.89; 59.95 | — |
| SECONDARY Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations |
35.42; 44.15; 30.82; 41.76 | — |
| SECONDARY Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations |
3.4; 3.5; 1.0; 1.3; 1.1; 1.7 | — |
| SECONDARY Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations |
0.57; 0.31; 0.42; 0.33; 0.25; 0.43 | — |
| SECONDARY TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations |
NA; NA; 11.8; 11.1; NA; NA | — |
| SECONDARY OS in Participants With PD-L1 Expression |
16.1; 19.5; 12.6; 18.2; 14.0; 17.8 | — |
| SECONDARY Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1 |
4.9; 7.0; 4.9; 6.9; 5.4; 6.8 | — |
| SECONDARY OS in Participants With Blood Tumor Mutational Burden (bTMB) |
10.3; 11.2; 8.5; 13.9; 10.5; 17.2 | — |
| SECONDARY Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1 |
4.3; 5.5; 4.4; 6.8; 5.2; 6.8 | — |
| SECONDARY Minimum Observed Serum Concentration (Cmin) of Atezolizumab |
76.7; 121; 154; 201; 213; 245 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Atezolizumab |
411 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event |
95.1; 92.3 | — |
| SECONDARY Percentage of Participants With Anti-therapeutic Antibodies (ATAs) |
1.4; 24.3 | — |
Summary
This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
- No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
- Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Adequate hematologic and end-organ function
Exclusion Criteria
- Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
- Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for Human Immunodeficiency Virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
Data sourced from ClinicalTrials.gov (NCT02409342). 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.