TriangleNCT02486718 · CITED IN SOURCE DOCUMENTS
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-29
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
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.
Participant flow
Baseline characteristics
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
DFS in All Randomized Stage II-IIIA Population
DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
Overall Survival (OS) in the ITT Population
Disease-free Rate at Year 3 in ITT Population
Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
Disease-free Rate at Year 5 in ITT Population
Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Maximum Plasma Concentration (Cmax) of Atezolizumab
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: Inclusion Criteria for Enrollment Phase * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histological or cytological diagnosis of Stage IB (tumors greater than or equal to \[\>/=\] 4 centimeters \[cm\])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009) * Participants must have had complete resection of NSCLC 4-12 weeks (\>/=28 days and less than or equal to \[\</=\] 84 days) prior to enrollment and must be adequately recovered from surgery * If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography \[CT\] and positron emission tomography \[PET\] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision * Eligible to receive a cisplatin-based chemotherapy regimen * Adequate hematologic and end-organ function * Women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC Exclusion Criteria: Exclusion Criteria for Enrollment Phase * Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures * Pregnant and lactating women * Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor * Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment * Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment * Participants with hearing impairment * Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol * Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than \[\>\] 90 percent \[%\]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation * History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis * Positive test for human immunodeficiency virus (HIV) * Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) or hepatitis C * Active tuberculosis * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Prior allogeneic bone marrow transplantation or solid organ transplant * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded) Specific Exclusions for Pemetrexed Treatment \- Participants with squamous cell histology Exclusion Criteria for Randomized Phase * Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization * Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study * Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study * Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed * Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 14 days prior to randomization
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.
- intervention Names
- Drug: Atezolizumab
- Drug: Cisplatin
- Drug: Vinorelbine
- Drug: Docetaxel
- Drug: Gemcitabine
- Drug: Pemetrexed
- label
- Atezolizumab
- type
- EXPERIMENTAL
- description
- Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.
- intervention Names
- Drug: Cisplatin
- Drug: Vinorelbine
- Drug: Docetaxel
- Drug: Gemcitabine
- Drug: Pemetrexed
- label
- Best Supportive Care
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Atezolizumab
- description
- Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
- name
- Atezolizumab
- other Names
- MPDL3280A; TECENTRIQ
- type
- DRUG
- arm Group Labels
- Atezolizumab
- Best Supportive Care
- description
- Participants will receive cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of up to four 21-day cycles.
- name
- Cisplatin
- type
- DRUG
- arm Group Labels
- Atezolizumab
- Best Supportive Care
- description
- Participants will receive vinorelbine 30 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.
- name
- Vinorelbine
- type
- DRUG
- arm Group Labels
- Atezolizumab
- Best Supportive Care
- description
- Participants will receive docetaxel 75 mg/m\^2 IV on Day 1 of each of the four 21-day cycles.
- name
- Docetaxel
- type
- DRUG
- arm Group Labels
- Atezolizumab
- Best Supportive Care
- description
- Participants will receive gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.
- name
- Gemcitabine
- type
- DRUG
- arm Group Labels
- Atezolizumab
- Best Supportive Care
- description
- Participants will receive pemetrexed 500 mg/m\^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.
- name
- Pemetrexed
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1280
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
- measure
- Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
- time Frame
- Up to 95 months
- description
- DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
- measure
- DFS in All Randomized Stage II-IIIA Population
- time Frame
- Up to 95 months
- description
- DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
- measure
- DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
- time Frame
- Up to 95 months
- secondary Outcomes
- description
- OS was defined as the time from randomization to death from any cause.
- measure
- Overall Survival (OS) in the ITT Population
- time Frame
- Baseline up to death from any cause (up to approximately 126 months)
- description
- DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- measure
- Disease-free Rate at Year 3 in ITT Population
- time Frame
- Year 3
- description
- DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- measure
- Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
- time Frame
- Year 3
- description
- DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- measure
- Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
- time Frame
- Year 3
- description
- DFS rate was defined as percentage of participants who were disease-free at Year 5. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- measure
- Disease-free Rate at Year 5 in ITT Population
- time Frame
- Year 5
- description
- DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- measure
- Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
- time Frame
- Year 5
- description
- DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- measure
- Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
- time Frame
- Year 5
- description
- DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
- measure
- DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population
- time Frame
- Up to 95 months
- description
- An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
- measure
- Percentage of Participants With Adverse Events (AEs)
- time Frame
- Up to 12 years
- description
- The percentage of ATA (Also called anti-drug antibodies (ADA))-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.
- measure
- Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
- time Frame
- Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)
- measure
- Maximum Plasma Concentration (Cmax) of Atezolizumab
- time Frame
- 30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)
- measure
- Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
- time Frame
- Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (Cycle length = 21 days), at study discontinuation visit (up to 12 months), Day 120 post last dose of atezolizumab (up to 16 months)
Full study description
- brief Summary
- This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
Source references
- references
- citation
- Okada M, Sugawara S, Watanabe Y, Saito H, Chen-Yoshikawa TF, Goto Y, Nishio W, Nakagawa S, Hayashi M, Kenmotsu H. IMpower010: 5-Year Outcomes of Atezolizumab in Japanese Patients With Resected Stage IB-IIIA Non-Small Cell Lung Cancer. Cancer Sci. 2026 Mar;117(3):749-758. doi: 10.1111/cas.70297. Epub 2025 Dec 19.
- pmid
- 41416818
- type
- DERIVED
- citation
- Felip E, Altorki N, Zhou C, Vallieres E, Csoszi T, Vynnychenko IO, Goloborodko O, Rittmeyer A, Reck M, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Fu C, Ballinger M, Deng Y, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA; IMpower010 Study Investigators. Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. J Clin Oncol. 2025 Jul 20;43(21):2343-2349. doi: 10.1200/JCO-24-01681. Epub 2025 May 30.
- pmid
- 40446184
- type
- DERIVED
- citation
- Zhou C, Srivastava MK, Xu H, Felip E, Wakelee H, Altorki N, Reck M, Liersch R, Kryzhanivska A, Oizumi S, Tanaka H, Hamm J, McCune SL, Bennett E, Gitlitz B, McNally V, Ballinger M, McCleland M, Zou W, Das Thakur M, Novello S. Comparison of SP263 and 22C3 immunohistochemistry PD-L1 assays for clinical efficacy of adjuvant atezolizumab in non-small cell lung cancer: results from the randomized phase III IMpower010 trial. J Immunother Cancer. 2023 Oct;11(10):e007047. doi: 10.1136/jitc-2023-007047.
- pmid
- 37903590
- type
- DERIVED
- citation
- Felip E, Altorki N, Zhou C, Vallieres E, Martinez-Marti A, Rittmeyer A, Chella A, Reck M, Goloborodko O, Huang M, Belleli R, McNally V, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase III trial. Ann Oncol. 2023 Oct;34(10):907-919. doi: 10.1016/j.annonc.2023.07.001. Epub 2023 Jul 17.
- pmid
- 37467930
- type
- DERIVED
- citation
- Mohindra NA, Patel JD. Top advances in lung cancer, 2021. Cancer. 2022 Oct 1;128(19):3434-3437. doi: 10.1002/cncr.34406. Epub 2022 Aug 10.
- pmid
- 35947027
- type
- DERIVED
- citation
- Felip E, Altorki N, Zhou C, Csoszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20.
- pmid
- 34555333
- type
- DERIVED
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- May 15, 2025
Preserved source evidence · Not medical advice