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Carcinoma, Non-Small-Cell LungPhase 3IMpower210NCT02813785

A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 38 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
565 participants
Where
38 sitesin 5 countries
Study dates
1 Jul 2016to 27 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Histologically documented, locally advanced or metastatic NSCLC
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
  • 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 and/or neoadjuvant regimen or combined modality with curative intent
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>/=) 12 weeks
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  • Adequate hematologic and end organ function
  • Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
  • Recovery from all acute toxicities from previous therapy

Who cannot join

  • Active or untreated central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated or not clinically stable
  • Leptomeningeal disease
  • Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
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  • Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
  • Pregnant or lactating women
  • Significant cardiovascular, pulmonary, or autoimmune disease
  • Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization
  • Prior treatment with or hypersensitivity to study drug(s) or related compounds
  • Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
  • Prior allogeneic bone marrow or solid organ transplant
  • Known PD-L1-negative expression status
  • Positive human immunodeficiency virus (HIV) or active hepatitis B or C
  • Receipt of a live attenuated vaccine within 4 weeks prior to randomization
  • Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
  • Treatment with systemic corticosteroids within 2 weeks prior to randomization

Trial locations and contacts

38 sites in 5 countries.

38 sites in 5 countries

China26 sites

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Chest Hospital; Oncology Department

    Beijing, 101149

  • Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

  • the First Hospital of Jilin University

    Changchun, 130021

  • Jilin Cancer Hospital

    Changchun, 132013

  • Changzhou First People's Hospital

    Changzhou, 213003

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Second Affiliated Hospital of Third Military Medical University

    Chongqing, 400030

  • Third Affiliated Hospital of Third Military Medical University

    Chongqing, 400042

  • Guangdong General Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510663

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital

    Hangzhou, 310018

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266003

  • Shanghai chest hospital

    Shanghai, 200030

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

South Korea4 sites

  • Kyungpook National University Medical Center

    Daegu, 41404

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Thailand4 sites

  • Chulalongkorn Hospital; Medical Oncology

    Bangkok, 10330

  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    Bangkok, 10400

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

  • CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit

    Chiang Mai, 50200

Other trials in Thailand

Malaysia3 sites

  • Hospital Sultan Ismail; Oncology

    Johor Bahru, 81100

  • Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi

    Kuala Lumpur, 50586

  • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

    Sarawak, Sarawak, 93586

Other trials in Malaysia

Singapore1 site

  • National Cancer Centre; Medical Oncology

    Singapore, 169610

Other trials in Singapore

About this study

Official title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy

This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.

Being tested
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Docetaxel
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), an engineered anti-PD-L1 antibodyDrug

    Also called MDPL3280A, RO5541267

    Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel will be administered as 75 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 21-day cycle.

Study groups in NCT02813785
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants will receive atezolizumab until loss of clinical benefit and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
DocetaxelActive comparatorParticipants will receive docetaxel until disease progression per standard RECIST v1.1 criteria or unacceptable toxicity and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Measured: Baseline until death from any cause (up to approximately 3 years)

Secondary outcomes (10)

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

    Measured: Baseline until disease progression or death from any cause (up to approximately 3 years)

  2. Percentage of Participants with Objective Response According to RECIST v1.1

    Measured: Baseline until disease progression or death from any cause (up to approximately 3 years)

  3. Duration of Objective Response According to RECIST v1.1

    Measured: From first objective response until disease progression or death from any cause (up to approximately 3 years)

  4. Percentage of Participants with Adverse Events

    Measured: From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years)

  5. Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

    Measured: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)

  6. Minimum Observed Serum Concentration (Cmin) of Atezolizumab

    Measured: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)

  7. Time to Deterioration (TTD) in Lung Cancer Symptoms According to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 C30)

    Measured: From start of treatment until treatment discontinuation (up to approximately 3 years)

  8. TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13)

    Measured: From start of treatment until treatment discontinuation (up to approximately 3 years)

  9. Health-Related Quality of Life According to EORTC QLQ-C30 Score

    Measured: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)

  10. Health-Related Quality of Life According to EORTC QLQ-LC13 Score

    Measured: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2016 (estimated)
  2. Study start1 Jul 2016
  3. Primary completion1 Aug 2019
  4. Study completion27 Dec 2022

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813785
Sponsor's protocol ID
YO29232
Acronym
IMpower210
Status last verified
Jan 2023
First submitted
23 Jun 2016
Last updated
10 Jan 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 38 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 9 inclusion and 18 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China, South Korea, Thailand, Malaysia, Singapore. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (OS) (time frame: Baseline until death from any cause (up to approximately 3 years)). 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 NCT02813785.

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 10 Jan 2023.

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