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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)

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ClinicalTrials.gov Identifier: NCT03456063
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE March 7, 2018
Last Update Posted Date May 13, 2020
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date November 20, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • Major pathological response (MPR) [ Time Frame: At time of surgery ]
    MPR is defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.
  • Independent Review Facility (IRF)-Assessed Event Free Survival (EFS) [ Time Frame: Approximately 84 months ]
    IRF-assessed EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, as assessed by the IRF; or death from any cause, whichever occurs first.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
Major pathological response (MPR) [ Time Frame: At time of surgery ]
MPR is defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • Overall Survival (OS) [ Time Frame: Approximately 84 months ]
    OS is defined as the time from randomization to death from any cause during the course of the study.
  • Investigator-Assessed EFS [ Time Frame: Approximately 84 months ]
    EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, as assessed by the investigator; or death from any cause, whichever occurs first.
  • Objective Response (OR) [ Time Frame: Prior to surgery, up to approximately 84 days ]
    Objective response is defined as a complete response or partial response, as determined by the investigator according to RECIST v1.1
  • Pathological Complete Response (pCR) [ Time Frame: At time of surgery ]
    pCR is defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory.
  • MPR [ Time Frame: At time of surgery ]
    MPR at the time of surgical resection as assessed by the investigator site pathology laboratory.
  • 2-Year OS [ Time Frame: Approximately 84 months ]
    OS is defined as the time from randomization to death from any cause. 2-Year OS will be analyzed together with OS.
  • 3-Year OS [ Time Frame: Approximately 84 months ]
    OS is defined as the time from randomization to death from any cause. 3-Year OS will be analyzed together with OS.
  • 2-Year Investigator-Assessed EFS [ Time Frame: Approximately 84 months ]
    EFS is defined as the time from the date of randomization to any of the following events, whichever occurs first: progression of disease that precludes surgery per RECIST v1.1, as assessed by the investigator; local or distant disease recurrence, as assessed by the investigator; or death due to any cause. 2-Year Investigator-Assessed EFS will be analyzed together with EFS.
  • 3-Year Investigator-Assessed EFS [ Time Frame: Approximately 84 months ]
    EFS is defined as the time from the date of randomization to any of the following events, whichever occurs first: progression of disease that precludes surgery per RECIST v1.1, as assessed by the investigator; local or distant disease recurrence, as assessed by the investigator; or death due to any cause. 3-Year Investigator-Assessed EFS will be analyzed together with EFS.
  • Disease-Free Survival (DFS) [ Time Frame: Approximately 84 months ]
    DFS is defined as the time from the first date of no disease to local or distant recurrence or death due to any cause, whichever occurs first, as determined by the investigator during the adjuvant treatment and observation follow-up
  • Change from baseline in HRQoL scores [ Time Frame: Approximately 84 months ]
    Change from baseline in HRQoL scores as assessed through use of the two-item GHS/HRQoL subscale (Questions 29 and 30) of the EORTC QLQ-C30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow-up assessments
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 84 months ]
  • Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: 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 84 months) ]
    Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
  • Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: 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 84 months) ]
    Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
  • Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab [ Time Frame: 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 84 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Event-Free Survival (EFS) [ Time Frame: Approximately 79 months ]
    EFS is defined as time from randomization to the first documented disease progression or recurrence as determined by the investigator, or death from any cause, whichever occurs first.
  • Overall Survival (OS) [ Time Frame: Approximately 79 months ]
    OS is defined as the time from randomization to death from any cause during the course of the study.
  • Objective Response (OR) [ Time Frame: From baseline up to approximately 84 days ]
    Objective response is defined as a complete response or partial response, as determined by the investigator according to RECIST v1.1
  • Pathological Complete Response (pCR) [ Time Frame: At time of surgery ]
    pCR is defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory.
  • MPR [ Time Frame: At time of surgery ]
    MPR at the time of surgical resection as assessed by the investigator site pathology laboratory.
  • OS [ Time Frame: From randomization to 2 years ]
    OS is defined as the time from randomization to death from any cause.
  • OS [ Time Frame: From randomization to 3 years ]
    OS is defined as the time from randomization to death from any cause.
  • EFS [ Time Frame: From randomization to 2 years ]
    EFS is defined as time from randomization to the first documented disease progression or recurrence as determined by the investigator, or death from any cause, whichever occurs first.
  • EFS [ Time Frame: From randomization to 3 years ]
    EFS is defined as time from randomization to the first documented disease progression or recurrence as determined by the investigator, or death from any cause, whichever occurs first.
  • Disease-Free Survival (DFS) [ Time Frame: Approximately 79 months ]
    DFS is defined as the time from the first date of no disease to local or distant recurrence or death due to any cause, whichever occurs first, as determined by the investigator during the adjuvant treatment and observation follow-up
  • Change from baseline in HRQoL scores [ Time Frame: Approximately 79 months ]
    Change from baseline in HRQoL scores as assessed through use of the two-item GHS/HRQoL subscale (Questions 29 and 30) of the EORTC QLQ-C30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow-up assessments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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 patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: 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

    Other Name: Tecentriq
  • Drug: 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
  • Drug: 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
    Other Name: Abraxane
  • Drug: 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
    Other Name: Alimta
  • Drug: 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
  • Drug: 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
  • Drug: 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
    Other Name: Gemzar
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
    • Drug: Nab-paclitaxel
    • Drug: Pemetrexed
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • 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

    Interventions:
    • Drug: Placebo Comparator
    • Drug: Nab-paclitaxel
    • Drug: Pemetrexed
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2019)
374
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2018)
302
Estimated Study Completion Date  ICMJE November 20, 2024
Estimated Primary Completion Date November 20, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Exclusion criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GO40241 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Japan,   Australia,   Austria,   Brazil,   China,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Poland,   Russian Federation,   Serbia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03456063
Other Study ID Numbers  ICMJE GO40241
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP