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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02657434




Registration number
NCT02657434
Ethics application status
Date submitted
14/01/2016
Date registered
15/01/2016
Date last updated
5/06/2020

Titles & IDs
Public title
A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2015-003605-42
Secondary ID [2] 0 0
GO29438
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed

Experimental: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed - Participants will receive intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experience clinical benefit during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.

Active Comparator: Arm B (Carboplatin or Cisplatin + Pemetrexed) - Participants will receive IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who do not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.


Treatment: Drugs: Atezolizumab
Participants will receive IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.

Treatment: Drugs: Carboplatin
Participants will receive IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.

Treatment: Drugs: Cisplatin
Participants will receive IV infusion of 75 mg/m^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.

Treatment: Drugs: Pemetrexed
Participants will receive IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timepoint [1] 0 0
Baseline then every 6 weeks for 12 months after Cycle (Cy;length=21 days) 1 Day (D) 1;every 9 weeks until radiographic disease progression, consent withdrawal, death, or study termination by Sponsor, whichever occurs first (up to approximately 44 months)
Primary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Baseline then every 6 weeks for 12 weeks following Cy1D1 (Cy length=21 days) & then every 9 weeks until death (up to approximately [app] 44 months)
Secondary outcome [1] 0 0
Percentage of Participants Who Survived at Year 1
Timepoint [1] 0 0
Year 1
Secondary outcome [2] 0 0
Percentage of Participants Who Survived at Year 2
Timepoint [2] 0 0
Year 2
Secondary outcome [3] 0 0
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1
Timepoint [3] 0 0
Baseline then every 6 weeks for 12 months following Cy1D1 (Cy length=21 days) thereafter every 9 weeks until radiographic disease progression, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first (up to app 44 months)
Secondary outcome [4] 0 0
Duration of Response as Determined by the Investigator Using RECIST v1.1
Timepoint [4] 0 0
Baseline then every 6 weeks for 12 months following Cy1D1 (Cy length=21 days) thereafter every 9 weeks until radiographic disease progression, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first (up to app 44 months)
Secondary outcome [5] 0 0
Time to Deterioration in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Timepoint [5] 0 0
Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to app 44 months)
Secondary outcome [6] 0 0
Time to Deterioration in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Timepoint [6] 0 0
Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 44 months)
Secondary outcome [7] 0 0
Change from Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Timepoint [7] 0 0
Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to app 44 months)
Secondary outcome [8] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin) Prior to Infusion
Timepoint [8] 0 0
Predose (Prd; 0 hour [h]) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to app 44 months)
Secondary outcome [9] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax) Prior to Infusion
Timepoint [9] 0 0
Prd (0h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days)&thereafter on D1 of every 8th cy; 0.5h post infusion (infusion duration=1h) on Cy1D1;at treatment discontinuation &then every 30 days (up to 120 days) after atezolizumab last dose (up to app 44 months)
Secondary outcome [10] 0 0
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Timepoint [10] 0 0
Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Secondary outcome [11] 0 0
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Timepoint [11] 0 0
Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Secondary outcome [12] 0 0
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Timepoint [12] 0 0
Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Secondary outcome [13] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab
Timepoint [13] 0 0
Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 44 months)

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC. Participants
with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are
eligible if the major histological component appears to be non-squamous

- No prior treatment for Stage IV non-squamous NSCLC. Participants with a sensitizing
mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic
lymphoma kinase (ALK) fusion oncogene are excluded. Participants with unknown EGFR and
ALK status require test results at screening from a local or central laboratory

- Participants who have received prior neo-adjuvant, radiotherapy, adjuvant
chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease
must have experienced a treatment-free interval of at least 6 months from
randomization since the last dose of chemotherapy and/or radiotherapy

- Participants should submit a pre-treatment tumor tissue sample if available before or
within 4 weeks after enrollment. If tumor tissue is not available, participants are
still eligible

- For participants enrolled in the extended China enrollment phase: current resident of
mainland China, Hong Kong, or Taiwan and of Chinese ancestry

- Measurable disease, as defined by RECIST v1.1

- Adequate hematologic and end organ function

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per
year during the treatment period and for at least 5 months after the last dose of
atezolizumab or 6 months after the last dose of cisplatin

- For men: agreement to remain abstinent or use contraceptive measures and agreement to
refrain from donating sperm
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer-Specific Exclusions

- Participants with a sensitizing mutation in the EGFR gene or an ALK fusion oncogene

- Active or untreated central nervous system (CNS) metastases as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and
prior radiographic assessments

- Spinal cord compression not definitively treated with surgery and/or radiation or
previously diagnosed and treated spinal cord compression without evidence that disease
has been clinically stable for greater than or equal to (>= 2) weeks prior to
randomization

- Leptomeningeal disease

- Uncontrolled tumor-related pain

- Uncontrolled or symptomatic hypercalcemia (greater than [>] 1.5 millimole/Liter
ionized calcium or calcium >12 milligrams/deciliter or corrected serum calcium >upper
limit of normal)

- Malignancies other than NSCLC within 5 years prior to randomization

- Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical
studies (e.g., participants whose PD-L1 expression status was determined during
screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not
eligible are excluded)

General Medical Exclusions:

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins

- History of certain autoimmune disease

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis

- All participants will be tested for human immunodeficiency virus (HIV) prior to the
inclusion into the study and HIV-positive participants will be excluded from the
clinical study

- Severe infections within 4 weeks prior to randomization

- Significant cardiovascular disease, such as New York Heart Association cardiac disease
(Class II or greater), myocardial infarction or cerebrovascular accident within 3
months prior to randomization, unstable arrhythmias, or unstable angina

- Illness or condition that may interfere with a participant's capacity to understand,
follow, and/or comply with study procedures

Exclusion Criteria Related to Medications and Chemotherapy:

- Prior treatment with EGFR inhibitors or ALK inhibitors

- Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to
initiation of study treatment

- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies

- Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization

- Treatment with systemic immunosuppressive medications

Exclusion Criteria Related to Chemotherapy:

- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing
compounds

- Participants with hearing impairment (cisplatin)

- Grade >=2 peripheral neuropathy as defined by National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria (cisplatin)

- Creatinine clearance (CRCL) <60 milliliters/minute (mL/min) for cisplatin or <45
mL/min for carboplatin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Sydney Adventist Hospital; Clinical Trial Unit - Sydney
Recruitment hospital [3] 0 0
St George Hospital; Medical Oncology - Sydney
Recruitment hospital [4] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [5] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [8] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [9] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2076 - Sydney
Recruitment postcode(s) [3] 0 0
2217 - Sydney
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3353 - Ballarat
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment outside Australia
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Indiana
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Malaga
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Valencia
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Taiwan
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Dalin, Chiayi
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Taiwan
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Kaohsiung
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Taiwan
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Liuying Township
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Ukraine
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Katerynoslav Governorate
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Ukraine
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Kharkiv Governorate
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Ukraine
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Cherkasy
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Ukraine
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Kirovograd
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Ukraine
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Sumy
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Ukraine
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Zaporizhzhya
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United Kingdom
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Bristol
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Cardiff
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Oxford
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Plymouth
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Romford
Country [138] 0 0
United Kingdom
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
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Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, Phase III, multicenter, open-label study designed to evaluate the
safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed
compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are
chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be
randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin +
Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in
two phases: Induction Phase and Maintenance Phase.
Trial website
https://clinicaltrials.gov/show/NCT02657434
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications