ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GO40241
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03456063
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a randomized, double-blinded study designed to evaluate the efficacy and safety 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.

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 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 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 : March 31, 2020
Estimated Study Completion Date : November 20, 2024

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

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

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. MPR [ Time Frame: At time of surgery ]
    MPR at the time of surgical resection as assessed by the investigator site pathology laboratory.

  6. OS [ Time Frame: From randomization to 2 years ]
    OS is defined as the time from randomization to death from any cause.

  7. OS [ Time Frame: From randomization to 3 years ]
    OS is defined as the time from randomization to death from any cause.

  8. 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.

  9. 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.

  10. 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

  11. 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



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.


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

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

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


Contacts
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

  Show 123 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03456063     History of Changes
Other Study ID Numbers: GO40241
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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
Paclitaxel
Atezolizumab
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors