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NCT01903993 · CITED IN SOURCE DOCUMENTS

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-10-02

This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m\^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

ORR (Modified RECIST)

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outcome · POSTED

PFS (Modified RECIST)

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outcome · POSTED

DOR (Modified RECIST)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Adult participants, \>/= 18 years of age * Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) * Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens * Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen * Measurable disease, as defined by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Known active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome * History of autoimmune disease * History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Active hepatitis B or hepatitis C * Prior treatment with docetaxel * Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants received docetaxel 75 milligram per meter square (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
    intervention Names
    1. Drug: Docetaxel
    label
    Docetaxel
    type
    ACTIVE_COMPARATOR
  2. description
    Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
    intervention Names
    1. Drug: Atezolizumab
    label
    Atezolizumab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Docetaxel
    description
    Participants received starting dose of 75 mg/m\^2 every three week (q3w) until disease progression, unacceptable toxicity or death. Dose modifications were according to the locally approved label. Participants randomized to receive docetaxel had to be premedicated with corticosteroids according to local practice.
    name
    Docetaxel
    type
    DRUG
  2. arm Group Labels
    1. Atezolizumab
    description
    Participants received atezolizumab of 1200 mg (equivalent to an average body weight-based dose of 15 milligram per kilogram \[mg/kg\]) which was administered by IV infusion q3w on Day 1 of each 21 day cycle. Participants were allowed to continue treatment beyond progression per response evaluation criteria in solid tumors (RECIST) v1.1 if they were experiencing clinical benefit per investigator, did not have a decline in performance status, did not have signs or symptoms of unequivocal progression, did not have tumor progression at critical sites, and signed an informed consent signature page acknowledging deferment any standard treatment options that may exist in favor of continuing atezolizumab.
    name
    Atezolizumab
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
287
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
    measure
    Overall Survival (OS)
    time Frame
    From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
secondary Outcomes
  1. description
    ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
    measure
    Objective Response Rate (ORR)
    time Frame
    Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
  2. description
    PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
    measure
    Progression-Free Survival (PFS)
    time Frame
    From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
  3. description
    DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
    measure
    Duration of Response (DOR)
    time Frame
    From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
  4. description
    ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l\< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
    measure
    ORR (Modified RECIST)
    time Frame
    From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
  5. description
    PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
    measure
    PFS (Modified RECIST)
    time Frame
    From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
  6. description
    DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
    measure
    DOR (Modified RECIST)
    time Frame
    From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
Full study description
brief Summary
This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m\^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Source references
references
  1. citation
    Dong Y, Zhu Y, Zhuo M, Chen X, Xie Y, Duan J, Bai H, Hao S, Yu Z, Yi Y, Guan Y, Yuan J, Xia X, Yi X, Wang J, Wang Z. Maximum Somatic Allele Frequency-Adjusted Blood-Based Tumor Mutational Burden Predicts the Efficacy of Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer. Cancers (Basel). 2022 Nov 17;14(22):5649. doi: 10.3390/cancers14225649.
    pmid
    36428744
    type
    DERIVED
  2. citation
    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.
    pmid
    33241650
    type
    DERIVED
  3. citation
    Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.
    pmid
    32115349
    type
    DERIVED
  4. citation
    Fehlings M, Jhunjhunwala S, Kowanetz M, O'Gorman WE, Hegde PS, Sumatoh H, Lee BH, Nardin A, Becht E, Flynn S, Ballinger M, Newell EW, Yadav M. Late-differentiated effector neoantigen-specific CD8+ T cells are enriched in peripheral blood of non-small cell lung carcinoma patients responding to atezolizumab treatment. J Immunother Cancer. 2019 Sep 12;7(1):249. doi: 10.1186/s40425-019-0695-9.
    pmid
    31511069
    type
    DERIVED
  5. citation
    Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10.
    pmid
    26970723
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        485217"><li>Two international, randomized, open-label clinical trials (<a href="/clinicaltrials/NCT02008227">OAK</a> [NCT02008227] and <a href="/clinicaltrials/NCT01903993">POPLAR</a> [NCT01903993]) demonstrated efficacy and safety in a total of 1,137 patients with NSCLC who previously received platinum chemotherapy.[<a href="#ci
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        onal, randomized, open-label clinical trials (<a href="/clinicaltrials/NCT02008227">OAK</a> [NCT02008227] and <a href="/clinicaltrials/NCT01903993">POPLAR</a> [NCT01903993]) demonstrated efficacy and safety in a total of 1,137 patients with NSCLC who previously received platinum chemotherapy.[<a href="#cit/section_12.67">67</a>,<
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      1. context
        Updated: May 15, 2025
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        May 15, 2025

    Preserved source evidence · Not medical advice