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)
- Conditions
- Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT03456063
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 453
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Atezolizumab + platinum-based chemotherapy Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody 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 Arm A: Atezolizumab + platinum-based chemotherapy Nab-paclitaxel 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 Arm B: Placebo + platinum-based chemotherapy Cisplatin 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 Arm B: Placebo + platinum-based chemotherapy Placebo Comparator 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 Arm B: Placebo + platinum-based chemotherapy Nab-paclitaxel 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 Arm B: Placebo + platinum-based chemotherapy Pemetrexed 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 Arm A: Atezolizumab + platinum-based chemotherapy Carboplatin 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 Arm A: Atezolizumab + platinum-based chemotherapy Cisplatin 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 Arm A: Atezolizumab + platinum-based chemotherapy Gemcitabine 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 Arm A: Atezolizumab + platinum-based chemotherapy Pemetrexed 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 Arm B: Placebo + platinum-based chemotherapy Carboplatin 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 Arm B: Placebo + platinum-based chemotherapy Gemcitabine 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
- Primary Outcome Measures
Name Time Method Independent Review Facility (IRF)-Assessed Event Free Survival (EFS) 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
Name Time Method Percentage of Participants With Adverse Events (AEs) Up to approximately 96 months Objective Response (OR) 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
Length of Surgical Delays Up to approximately 96 months Length of surgical delays.
Investigator-Assessed EFS 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.
2-Year and 3-Year OS 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.
Change from baseline in HRQoL scores 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
Number and Severity of Surgical Related Adverse Events Up to approximately 96 months Number of Surgical Delays Up to approximately 96 months Number of surgical delays.
Maximum Observed Serum Atezolizumab Concentration (Cmax) 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.
Pathological Complete Response (pCR) 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 and all sampled lymph nodes as assessed by central and local pathology laboratory.
Major Pathological Response (MPR) 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.
Overall Survival (OS) Up to approximately 96 months OS is defined as the time from randomization to death from any cause during the course of the study.
Disease-Free Survival (DFS) 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
2-Year and 3-Year Independent Review Facility-Assessed EFS 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.
2-Year and 3-Year Investigator-Assessed EFS 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.
Number of Operative and Post-Operative Complications Up to approximately 96 months Number of operative and post-operative complications.
Reasons for Surgical Cancellations Up to approximately 96 months Reasons for surgical cancellations.
Minimum Observed Serum Atezolizumab Concentration (Cmin) 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.
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab 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)
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Trial Locations
- Locations (116)
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
🇯🇵Tokyo, Japan
Arizona Oncology
🇺🇸Tucson, Arizona, United States
USC Norris Cancer Center
🇺🇸Los Angeles, California, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
🇺🇸Orange, California, United States
UC Davis Cancer Center
🇺🇸Sacramento, California, United States
Scripps Clinic
🇺🇸San Diego, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
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