Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2024
• Main ID: NCT02486718
• Date of registration: 04/06/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
• Scientific title: A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
• Date of first enrolment: October 31, 2015
• Target sample size: 1280
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02486718
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Canada, China, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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 [ 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


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Atezolizumab

Drug: Pemetrexed

Drug: Gemcitabine

Drug: Docetaxel

Drug: Cisplatin

Drug: Vinorelbine

Primary Outcome(s)

Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray [Time Frame: From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 131 months)]

Secondary Outcome(s)

Overall Survival (OS) in the ITT Population [Time Frame: Baseline up to death from any cause (up to approximately 131 months)]

Maximum Plasma Concentration (Cmax) of Atezolizumab [Time Frame: Post-infusion on Day 1 of Cycle 1 (cy length = 21 days)]

Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray [Time Frame: Year 5]

Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray [Time Frame: Year 3]

Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab [Time Frame: Prior to infusion on D1 of Cy2, 3, 4, 8, 16 (Cy length = 21 days), and at study termination (up to approximately 131 months)]

DFS Within Selected Populations [Time Frame: From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 67 months)]

Percentage of Participants with Adverse Events [Time Frame: Baseline up to approximately 131 months]

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [Time Frame: Predose (Hour 0) on Day (D) 1 of Cycles (Cy) 1, 2, 3, 4, 8, 16 (Cy length=21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)]

Secondary ID(s)

2014-003205-15

GO29527

Source(s) of Monetary Support

Please refer to primary and secondary sponsors