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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03456063
Ethics application status
Date submitted
5/03/2018
Date registered
7/03/2018
Date last updated
20/11/2024

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
2023-504209-35-00
Secondary ID [2] 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
31/12/2025
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
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Germany
State/province [31] 0 0
Freiburg
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Germany
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Gauting
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Germany
State/province [33] 0 0
Gerlingen
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Germany
State/province [34] 0 0
Großhansdorf
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Germany
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Halle
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Germany
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Oldenburg
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Germany
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Regensburg
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Germany
State/province [38] 0 0
Würzburg
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Hungary
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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
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Kfar-Saba
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Israel
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Tel Aviv
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Italy
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Lazio
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Italy
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Lombardia
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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
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Japan
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Fukuoka
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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
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Busan
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Korea, Republic of
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Gyeonggi-do
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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
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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
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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
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
State/province [76] 0 0
Valencia
Country [77] 0 0
Sweden
State/province [77] 0 0
Linköping
Country [78] 0 0
Sweden
State/province [78] 0 0
Lund
Country [79] 0 0
Sweden
State/province [79] 0 0
Stockholm
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Sweden
State/province [80] 0 0
Uppsala
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Switzerland
State/province [81] 0 0
Lausanne
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Switzerland
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Zürich
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Taiwan
State/province [83] 0 0
Kaohsiung
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Taiwan
State/province [84] 0 0
Taipei
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Taiwan
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Xitun Dist.
Country [86] 0 0
Thailand
State/province [86] 0 0
Bangkok
Country [87] 0 0
Thailand
State/province [87] 0 0
ChiangMai
Country [88] 0 0
Ukraine
State/province [88] 0 0
Dnipropetrovsk
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Birmingham
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Leeds
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Liverpool
Country [92] 0 0
United Kingdom
State/province [92] 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/study/NCT03456063
Trial related presentations / publications
Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.
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/study/NCT03456063