Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous in Patients With Stage IV Non-Small Cell Lung Cancer

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: NCT03735121
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) in patients with Non-Small Cell Lung Cancer (NSCLC). A dose-finding part (Part 1) will aim to identify the dose of atezolizumab SC that yields drug exposure that is comparable to that of atezolizumab IV. A dose-confirmation part (Part 2) will aim to demonstrate the non inferiority of observed drug exposure following treatment with atezolizumab SC at the identified dose compared with historical drug exposure following treatment with atezolizumab IV.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Drug: rHuPH20 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Intervention study model can be sequential or in parallel.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Part Phase Ib/II Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous in Patients With Stage IV Non-Small Cell Lung Cancer
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : April 22, 2021
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Atezolizumab+Bevacizumab+Chemotherapy (Part 2) Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq

Drug: Bevacizumab
Bevacizumab will be administered as per the schedule specified in the arm.
Other Name: Avastin

Drug: Carboplatin
Carboplatin will be administered as per the schedule specified in the arm.

Drug: Paclitaxel
Paclitaxel will be administered as per the schedule specified in the arm.

Experimental: Cohort 1: Atezolizumab+rHuPH20 (Part 1)
Atezolizumab+rHuPH20, followed by Atezolizumab
Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq

Drug: rHuPH20
rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Other Name: ENHANZE

Experimental: Cohort 2: Atezolizumab+rHuPH20 (Part 1)
Atezolizumab+rHuPH20, followed by Atezolizumab
Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq

Drug: rHuPH20
rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Other Name: ENHANZE

Experimental: Cohort 3: Atezolizumab+rHuPH20(Part 1)
Atezolizumab+rHuPH20, followed by Atezolizumab
Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Other Name: Tecentriq

Drug: rHuPH20
rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Other Name: ENHANZE




Primary Outcome Measures :
  1. Observed Concentration of Atezolizumab in Serum at Cycle 1 in Part 1 [ Time Frame: Predose of Cycle 2. Cycle length is 21 days. ]
  2. Observed Concentration of Atezolizumab in Serum at Cycle 1 in Part 2 [ Time Frame: Predose of Cycle 2. Cycle length is 21 days. ]

Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Atezolizumab in Part 1 [ Time Frame: At Cycle 1. Cycle length is 21 days. ]
  2. Concentration at the End of a Dosing Interval (Ctrough) of Atezolizumab in Part 1 [ Time Frame: At Cycles 1-3, 7, 11 and 15 and at treatment discontinuation visit. Each cycle is 21 days. ]
  3. Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Part 1 [ Time Frame: At Cycles 1-4, 8, 12 and 16. Each cycle is 21 days. ]
  4. Time to Maximum Plasma Concentration (Tmax) of Atezolizumab in Part 1 [ Time Frame: At Cycles 1-4, 8, 12 and 16. Each cycle is 21 days. ]
  5. Percentage of Participants with Adverse Events in Part 1 and Part 2 [ Time Frame: Up to 4.6 years ]
  6. Objective Response Rate (ORR) in Part 2 [ Time Frame: Up to 4.6 years ]
    ORR is defined as the proportion of patients with a partial response (PR) or complete response (CR) as determined by the investigator according to RECIST v1.1.

  7. Progression-Free Survival (PFS) in Part 2 [ Time Frame: Up to 4.6 years ]
    PFS is defined as the time from the date of study entry to the date of documented disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever is earlier.

  8. Overall Survival (OS) in Part 2 [ Time Frame: Up to 4.6 years ]


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.


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

Inclusion Criteria:

  • Histologically or cytologically documented locally advanced or metastatic NSCLC
  • Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen.
  • Measurable disease as defined by RECIST v1.1
  • ECOG Performance Status of 0 or 1
  • Life expectancy ≥12 weeks
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Symptomatic, untreated, or actively progressing CNS metastases
  • Uncontrolled or symptomatic hypercalcemia
  • Pregnancy or breastfeeding
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
  • Severe infection ≤ 4 weeks
  • Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment
  • Significant cardiovascular disease
  • Prior allogeneic stem cell or solid organ transplantation
  • Treatment with a live, attenuated vaccine ≤ 4 weeks
  • Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug
  • Treatment with systemic immunosuppressive medication ≤ 2 weeks

Additional Exclusion Criteria (Part 2 Only)

  • No prior anticancer treatment for NSCLC, CD137 agonists or immune checkpoint inhibitors
  • Uncontrolled hypertension, history of hypertensive crisis or hypertensive encephalopathy
  • Significant vascular disease ≤ 6 months
  • History of hemoptysis ≤ 1 month
  • Evidence of active bleeding, bleeding diathesis or coagulopathy
  • Current or recent use of aspirin or with dipyramidole, ticlopidine, clopidogrel, and cilostazol
  • Current use of anticoagulants or thrombolytic agents for therapeutic purposes unstable for > 2 weeks prior to enrollment
  • History of abdominal or tracheosphageal fistula or gastrointestinal perforation ≤ 6 months
  • Clinical signs of gastrointestinal obstruction or requirement for routine treatment
  • Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Proteinuria
  • Clear tumor infiltration into the thoracic great vessels or cavitation of pulmonary lesions
  • Grade ≥ 2 peripheral neuropathy

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): NCT03735121


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: BP40657 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Layout table for location information
Chile
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas Recruiting
Recoleta, Chile, 8420383
France
Aphm; Cpcet Recruiting
Marseille, France, 13385
Institut Curie Not yet recruiting
Paris, France, 75005
Ico Rene Gauducheau; Oncologie Recruiting
Saint Herblain, France, 44805
Italy
Asst Papa Giovanni XXIII; Oncologia Medica Not yet recruiting
Bergamo, Lombardia, Italy, 24128
Korea, Republic of
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Centre; Medical Oncology Recruiting
Seoul, Korea, Republic of, 135-170
Latvia
Riga East Clinical University Hospital Latvian Oncology Centre Recruiting
Riga, Latvia, LV-1079
New Zealand
Christchurch Clinical Studies Trust Ltd Active, not recruiting
Christchurch, New Zealand, 8011
Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz Recruiting
Warszawa, Poland, 02-781
Spain
Clinica Universitaria de Navarra; Servicio de Oncologia Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Universitario Vall d'Hebron - PPDS Active, not recruiting
Barcelona, Spain, 08035
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
St James Hospital; Dept of Oncology/Hematology Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03735121     History of Changes
Other Study ID Numbers: BP40657
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Bevacizumab
Carboplatin
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors