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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03456063




Registration number
NCT03456063
Ethics application status
Date submitted
5/03/2018
Date registered
7/03/2018
Date last updated
24/04/2024

Titles & IDs
Public title
A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
Scientific title
A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
GO40241
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Treatment: Drugs - Placebo Comparator
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine

Experimental: Arm A: Atezolizumab + platinum-based chemotherapy - Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy
Platinum-based chemotherapy may include:
carboplatin + pemetrexed
carboplatin + nab-paclitaxel
cisplatin + pemetrexed
cisplatin + gemcitabine
Post-operative adjuvant treatment will consist of 16-cycles of atezolizumab

Placebo Comparator: Arm B: Placebo + platinum-based chemotherapy - Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy
Platinum-based chemotherapy may include:
carboplatin + pemetrexed
carboplatin + nab-paclitaxel
cisplatin + pemetrexed
cisplatin + gemcitabine
Participants will receive best supportive care and monitoring after surgery


Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase

Treatment: Drugs: Placebo Comparator
Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Treatment: Drugs: Nab-paclitaxel
Nab-paclitaxel 100 mg/m^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase

Treatment: Drugs: Pemetrexed
Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Treatment: Drugs: Carboplatin
Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Treatment: Drugs: Cisplatin
Cisplatin 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Treatment: Drugs: Gemcitabine
Gemcitabine 1250 mg/m^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Independent Review Facility (IRF)-Assessed Event Free Survival (EFS)
Timepoint [1] 0 0
Up to approximately 96 months
Secondary outcome [1] 0 0
Pathological Complete Response (pCR)
Timepoint [1] 0 0
At time of surgery
Secondary outcome [2] 0 0
Major Pathological Response (MPR)
Timepoint [2] 0 0
At time of surgery
Secondary outcome [3] 0 0
Objective Response (OR)
Timepoint [3] 0 0
Prior to surgery, up to approximately 84 days
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to approximately 96 months
Secondary outcome [5] 0 0
Investigator-Assessed EFS
Timepoint [5] 0 0
Up to approximately 96 months
Secondary outcome [6] 0 0
Disease-Free Survival (DFS)
Timepoint [6] 0 0
Up to approximately 96 months
Secondary outcome [7] 0 0
2-Year and 3-Year OS
Timepoint [7] 0 0
Up to approximately 96 months
Secondary outcome [8] 0 0
2-Year and 3-Year Independent Review Facility-Assessed EFS
Timepoint [8] 0 0
Up to approximately 96 months
Secondary outcome [9] 0 0
2-Year and 3-Year Investigator-Assessed EFS
Timepoint [9] 0 0
Up to approximately 96 months
Secondary outcome [10] 0 0
Change from baseline in HRQoL scores
Timepoint [10] 0 0
Up to approximately 96 months
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [11] 0 0
Up to approximately 96 months
Secondary outcome [12] 0 0
Number and Severity of Surgical Related Adverse Events
Timepoint [12] 0 0
Up to approximately 96 months
Secondary outcome [13] 0 0
Number of Surgical Delays
Timepoint [13] 0 0
Up to approximately 96 months
Secondary outcome [14] 0 0
Length of Surgical Delays
Timepoint [14] 0 0
Up to approximately 96 months
Secondary outcome [15] 0 0
Number of Operative and Post-Operative Complications
Timepoint [15] 0 0
Up to approximately 96 months
Secondary outcome [16] 0 0
Reasons for Surgical Cancellations
Timepoint [16] 0 0
Up to approximately 96 months
Secondary outcome [17] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Timepoint [17] 0 0
Pre-dose on Day 1 of Cycles 1 and 3 (each cylce is 21 days) for Neoadjuvant Treatment; pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 (each cycle is 21 days) for Arm A; at treatment or observation follow-up discontinuation (up to approximately 96 months)
Secondary outcome [18] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Timepoint [18] 0 0
Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)
Secondary outcome [19] 0 0
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab
Timepoint [19] 0 0
Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)

Eligibility
Key inclusion criteria
Inclusion criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB
(T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on
the 8th edition of the AJCC/UICC staging system

- Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection
with curative intent

- Adequate pulmonary and cardiac function to undergo surgical resection

- Measurable disease as defined by RECIST v1.1

- Adequate hematologic and end organ function

- Negative HIV test at screening

- Negative for active HBV and HCV at screening

- Adequate tissue for PD-L1 IHC assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma

- Mixed NSCLC and small cell lung cancer histology

- Any prior therapy for lung cancer

- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death treated expected
curative outcome

- Non-squamous NSCLC histology with activating ALK and EGFR mutation

- Pregnant or lactating women

- History of autoimmune disease

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or evidence of active of active pneumonitis on screening chest Computed
Tomography (CT) scan

- Prior treatment with cluster of differentiation 137 (CD137) agonist or immune
checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1
therapeutic antibody

- Severe infection within 4 weeks prior to randomization

- Significant history of cardiovascular disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/01/2025
Actual
Sample size
Target
Accrual to date
Final
453
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St George Hospital; Cancer Care Centre - Kogarah
Recruitment hospital [2] 0 0
Box Hill Hospital; Oncology - Box Hill
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3051 - North Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Linz
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Brazil
State/province [21] 0 0
MG
Country [22] 0 0
Brazil
State/province [22] 0 0
RS
Country [23] 0 0
Brazil
State/province [23] 0 0
SP
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
France
State/province [25] 0 0
Angers
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Saint Quentin
Country [28] 0 0
France
State/province [28] 0 0
Saint-Mande
Country [29] 0 0
France
State/province [29] 0 0
Strasbourg
Country [30] 0 0
France
State/province [30] 0 0
Toulon
Country [31] 0 0
Germany
State/province [31] 0 0
Freiburg
Country [32] 0 0
Germany
State/province [32] 0 0
Gauting
Country [33] 0 0
Germany
State/province [33] 0 0
Gerlingen
Country [34] 0 0
Germany
State/province [34] 0 0
Großhansdorf
Country [35] 0 0
Germany
State/province [35] 0 0
Halle
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Germany
State/province [36] 0 0
Oldenburg
Country [37] 0 0
Germany
State/province [37] 0 0
Regensburg
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Germany
State/province [38] 0 0
Würzburg
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Hungary
State/province [39] 0 0
Budapest
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
State/province [42] 0 0
Kfar-Saba
Country [43] 0 0
Israel
State/province [43] 0 0
Tel Aviv
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Italy
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Lazio
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Italy
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Lombardia
Country [46] 0 0
Italy
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Toscana
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Italy
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Veneto
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Japan
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Aichi
Country [49] 0 0
Japan
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Fukuoka
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Japan
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Fukushima
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Japan
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Hiroshima
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Japan
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Hyogo
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Okayama
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Japan
State/province [56] 0 0
Osaka
Country [57] 0 0
Japan
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Tokyo
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Korea, Republic of
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Busan
Country [59] 0 0
Korea, Republic of
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Gyeonggi-do
Country [60] 0 0
Korea, Republic of
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Seoul
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Poland
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Gdansk
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Poland
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Kraków
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Poland
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Warszawa
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Russian Federation
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Moskovskaja Oblast
Country [65] 0 0
Russian Federation
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Sankt Petersburg
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Serbia
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Belgrade
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Slovenia
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Golnik
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South Africa
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Johannesburg
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South Africa
State/province [69] 0 0
Pretoria
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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Navarra
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Spain
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Vizcaya
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Spain
State/province [74] 0 0
Madrid
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Spain
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Malaga
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Spain
State/province [76] 0 0
Sevilla
Country [77] 0 0
Spain
State/province [77] 0 0
Valencia
Country [78] 0 0
Sweden
State/province [78] 0 0
Linköping
Country [79] 0 0
Sweden
State/province [79] 0 0
Lund
Country [80] 0 0
Sweden
State/province [80] 0 0
Stockholm
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Sweden
State/province [81] 0 0
Uppsala
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Switzerland
State/province [82] 0 0
Lausanne
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Switzerland
State/province [83] 0 0
Zürich
Country [84] 0 0
Taiwan
State/province [84] 0 0
Kaohsiung
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taipei
Country [86] 0 0
Taiwan
State/province [86] 0 0
Xitun Dist.
Country [87] 0 0
Thailand
State/province [87] 0 0
Bangkok
Country [88] 0 0
Thailand
State/province [88] 0 0
ChiangMai
Country [89] 0 0
Ukraine
State/province [89] 0 0
Dnipropetrovsk
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Birmingham
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Leeds
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Liverpool
Country [93] 0 0
United Kingdom
State/province [93] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blinded study designed to evaluate the efficacy, safety,
pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A)
or placebo in combination with platinum-based chemotherapy in participants with resectable
Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label
adjuvant/postoperative atezolizumab or best supportive care and monitoring.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03456063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03456063