Non-Small Cell Lung CancerPhase 2NCT01846416
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]
A Phase 2 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 31 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 30 May 2013to 18 Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled hypercalcemia
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
United States25 sites
University Of Colorado
Aurora, Colorado, 80045
Northwest Georgia Oncology Centers P.C.
Carrollton, Georgia, 30117
The University of Chicago Medical Center
Chicago, Illinois, 60637
Ohio State Uni Hospital
Columbus, Ohio, 43210-1250
Duke University Health Systems
Durham, North Carolina, 27710
Oncology Hematology Care, Inc.
Hamilton, Ohio, 45103
Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology
Hershey, Pennsylvania, 17033
Carolina BioOncology Institute; Can Therapy & Res Ctr
Huntersville, North Carolina, 28078
Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr
Lebanon, New Hampshire, 03756
SCRI-Tennessee Oncology
Nashville, Tennessee, 37203
Yale University School Of Medicine
New Haven, Connecticut, 06510
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Florida Hospital Cancer Inst
Orlando, Florida, 32804
Stanford University/Lucile Packard Children's Hospital
Palo Alto, California, 94304
Penn Presbyterian Medical Center; Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Virginia Cancer Institute
Richmond, Virginia, 23226
Huntsman Cancer Institute; University of Utah
Salt Lake City, Utah, 84112
The Angeles Clinic and Research Institute, Santa Monica Office
Santa Monica, California, 90025
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, 85258
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195
Florida Cancer Specialists.
St. Petersburg, Florida, 33705
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, 33612
Georgetown University
Washington D.C., District of Columbia, 20007
United Kingdom3 sites
Queen Mary University of London
London, EC1M 6BQ
Royal Marsden Hospital - Fulham; Oncology Department
London, SW3 6JJ
Royal Marsden Hospital - Fulham
London, SW3 6JJ
About this study
Official title: A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
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:
- Participants with no prior chemotherapy for advanced disease;
- Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
- Participants who are 2L+ and previously treated for brain metastases.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyDrug
Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab (MPDL3280): 1L Participants | Experimental | Participants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. Receives: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody |
| Atezolizumab (MPDL3280): 2L+ Participants | Experimental | Participants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. Receives: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody |
| Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants | Experimental | Participants with previously treated brain metastases and who progress during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. Receives: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.
Measured: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Secondary outcomes (13)
Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)
Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.
Measured: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Duration of Objective Response According to RECIST v1.1
Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.
Measured: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Percentage of Participants With 6-Month Duration of Objective Response
Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.
Measured: Month 6
Percentage of Participants With Disease Progression or Death According to RECIST v1.1
For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Measured: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Progression-Free Survival (PFS) According to RECIST v1.1
PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.
Measured: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1
Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Measured: Months 6, 12 and 30
Percentage of Participants With Disease Progression or Death According to Modified RECIST
For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Measured: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
PFS According to Modified RECIST
PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.
Measured: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST
Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Measured: Months 6, 12 and 30
Percentage of Participants With Death
Participants were followed for survival throughout the study.
Measured: Baseline till death or up to 20 months, whichever occurred first
Overall Survival (OS)
OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.
Measured: Baseline till death or up to 20 months, whichever occurred first
Maximum Plasma Concentration (Cmax) for Atezolizumab
Measured: Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1
Minimum Plasma Concentration (Cmin) for Atezolizumab
Measured: Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start30 May 2013
- Primary completion7 Jan 2015
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846416
- Sponsor's protocol ID
- GO28625
- Other IDs
- 2013-000177-69
- Status last verified
- Dec 2018
- First submitted
- 1 May 2013
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.
PubMed 33241650
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01846416
- Acronym / sponsor ID
- GO28625
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2013 (actual)
- Primary completion
- 7 Jan 2015 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 16 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants with no prior chemotherapy for advanced disease;
- Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
- Participants who are 2L+ and previously treated for brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab (MPDL3280): 1L Participants | Experimental | Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyParticipants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. |
| Atezolizumab (MPDL3280): 2L+ Participants | Experimental | Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyParticipants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
| Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants | Experimental | Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyParticipants with previously treated brain metastases and who progress during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
- Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases.
- Leptomeningeal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyAtezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression. | Drug | Atezolizumab (MPDL3280): 1L Participants, Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants, Atezolizumab (MPDL3280): 2L+ Participants |
Primary outcome
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.
13 secondary outcomes
Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)
Time frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Duration of Objective Response According to RECIST v1.1
Time frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Percentage of Participants With 6-Month Duration of Objective Response
Time frame: Month 6
Percentage of Participants With Disease Progression or Death According to RECIST v1.1
Time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Progression-Free Survival (PFS) According to RECIST v1.1
Time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1
Time frame: Months 6, 12 and 30
Percentage of Participants With Disease Progression or Death According to Modified RECIST
Time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
PFS According to Modified RECIST
Time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST
Time frame: Months 6, 12 and 30
Percentage of Participants With Death
Time frame: Baseline till death or up to 20 months, whichever occurred first
Overall Survival (OS)
Time frame: Baseline till death or up to 20 months, whichever occurred first
Maximum Plasma Concentration (Cmax) for Atezolizumab
Time frame: Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1
Minimum Plasma Concentration (Cmin) for Atezolizumab
Time frame: Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33241650Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 31 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, United Kingdom, Belgium, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01846416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.