Phase 2
N=137
A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01846416 ↗Enrolled (actual)
137
Serious AEs
50.4%
Results posted
Dec 2016
Primary outcome: Primary: Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) — 32; 21; 23 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) |
32; 21; 23 | — |
| SECONDARY Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1) |
29; 19; 23 | — |
| SECONDARY Duration of Objective Response According to RECIST v1.1 |
9.2; 17.0; NA | — |
| SECONDARY Percentage of Participants With 6-Month Duration of Objective Response |
75.0; 91.7; 66.7 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death According to RECIST v1.1 |
67.7; 74.2; 84.6 | — |
| SECONDARY Progression-Free Survival (PFS) According to RECIST v1.1 |
4.5; 2.7; 2.5 | — |
| SECONDARY Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1 |
33.50; 32.29; 15.38; 20; 23; NA | — |
| SECONDARY Percentage of Participants With Disease Progression or Death According to Modified RECIST |
58.1; 66.7; 69.2 | — |
| SECONDARY PFS According to Modified RECIST |
5.5; 3.7; 4.3 | — |
| SECONDARY Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST |
43.12; 39.10; 44.87; 31; 29; 24 | — |
| SECONDARY Percentage of Participants With Death |
74.2; 76.3; 76.9 | — |
| SECONDARY Overall Survival (OS) |
14.4; 9.3; 6.8 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Atezolizumab |
405 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) for Atezolizumab |
68.8; 90.6; 123; 206; 135 | — |
Summary
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.
Eligible participants will be categorized in to three groups as follows:
1. Participants with no prior chemotherapy for advanced disease;
2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
3. Participants who are 2L+ and previously treated for brain metastases.
Eligibility Criteria
Inclusion Criteria
- Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC
- PDL1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. A positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion
- Eastern Cooperative Oncology group Performance Status of 0 or 1
- Life expectancy greater than or equal to 12 weeks
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1
- Adequate hematologic and end organ function
Exclusion Criteria
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- Known central nervous system disease, including treated brain metastases in the following participants:
- who will not receive prior chemotherapy for advanced disease
- who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2L+ participants)
- Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases.
- Leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled hypercalcemia
Data sourced from ClinicalTrials.gov (NCT01846416). 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.