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Trial record 1 of 1 for:    GO40241
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456063
Recruitment Status : Active, not recruiting
First Posted : March 7, 2018
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Placebo Comparator Drug: Nab-paclitaxel Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : April 20, 2025
Estimated Study Completion Date : April 20, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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: 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

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

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




Primary Outcome Measures :
  1. Independent Review Facility (IRF)-Assessed Event Free Survival (EFS) [ Time Frame: Up to approximately 96 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, or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Pathological Complete Response (pCR) [ Time Frame: At time of surgery ]
    pCR is defined as the absence of any viable primary tumor cells at the time of surgical resection in the primary tumor as assessed by central and local pathology laboratory.

  2. Major Pathological Response (MPR) [ Time Frame: At time of surgery ]
    MPR is defined as ≤ 10% residual viable tumor cells at the time of surgical resection in the primary tumor, as assessed by central and local pathology laboratory.

  3. 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

  4. Overall Survival (OS) [ Time Frame: Up to approximately 96 months ]
    OS is defined as the time from randomization to death from any cause during the course of the study.

  5. Investigator-Assessed EFS [ Time Frame: Up to approximately 96 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.

  6. Disease-Free Survival (DFS) [ Time Frame: Up to approximately 96 months ]
    DFS is defined as the time from the first date of no disease to local or distant recurrence (including occurrence of new primary NSCLC) or death due to any cause, whichever occurs first, as determined by the investigator during the adjuvant treatment and observation follow-up

  7. 2-Year and 3-Year OS [ Time Frame: Up to approximately 96 months ]
    The 2-year and 3-year OS rate is defined as the probability that a participant will be alive 2 years and 3 years after randomization, respectively.

  8. 2-Year and 3-Year Independent Review Facility-Assessed EFS [ Time Frame: Up to approximately 96 months ]
    EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Independent Review Facility.

  9. 2-Year and 3-Year Investigator-Assessed EFS [ Time Frame: Up to approximately 96 months ]
    EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Investigator.

  10. Change from baseline in HRQoL scores [ Time Frame: Up to approximately 96 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

  11. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 96 months ]
  12. Number and Severity of Surgical Related Adverse Events [ Time Frame: Up to approximately 96 months ]
  13. Number of Surgical Delays [ Time Frame: Up to approximately 96 months ]
    Number of surgical delays.

  14. Length of Surgical Delays [ Time Frame: Up to approximately 96 months ]
    Length of surgical delays.

  15. Number of Operative and Post-Operative Complications [ Time Frame: Up to approximately 96 months ]
    Number of operative and post-operative complications.

  16. Reasons for Surgical Cancellations [ Time Frame: Up to approximately 96 months ]
    Reasons for surgical cancellations.

  17. 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 96 months) ]
    Cmin is the minimum (or trough) concentration that a study drug achieves in the body.

  18. 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 96 months) ]
    Cmax is the maximum (or peak) concentration that a study drug achieves in the body.

  19. 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 96 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456063


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03456063    
Other Study ID Numbers: GO40241
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Paclitaxel
Carboplatin
Pemetrexed
Atezolizumab
Antibodies
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents