Trial record 1 of 1 for:
Neoadjuvant treatment with Atezolizumab or Placebo in combination with Platinum-Based
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 |
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Recruitment Status :
Active, not recruiting
First Posted : March 7, 2018
Last Update Posted : January 6, 2022
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 |
| 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
MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Atezolizumab + platinum-based chemotherapy
Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy Platinum-based chemotherapy may include:
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 |
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Placebo Comparator: Arm B: Placebo + platinum-based chemotherapy
Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy Platinum-based chemotherapy may include:
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 :
- 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 :
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 96 months ]
- Number and Severity of Surgical Related Adverse Events [ Time Frame: Up to approximately 96 months ]
- Number of Surgical Delays [ Time Frame: Up to approximately 96 months ]Number of surgical delays.
- Length of Surgical Delays [ Time Frame: Up to approximately 96 months ]Length of surgical delays.
- Number of Operative and Post-Operative Complications [ Time Frame: Up to approximately 96 months ]Number of operative and post-operative complications.
- Reasons for Surgical Cancellations [ Time Frame: Up to approximately 96 months ]Reasons for surgical cancellations.
- 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.
- 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.
- 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) ]
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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
Show 130 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | January 6, 2022 |
| Last Verified: | January 2022 |
| 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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Atezolizumab 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 |
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 |