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

Phase 1

• Conditions: on-small cell lung cancer (NSCLC); MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002328-18-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

- Age >=18 years
- Ability to comply with the study protocol, in the investigator's judgment
- Measurable disease as defined by RECIST v1.1
- Eastern cooperative oncology group performance status of 0 or 1
- Life expectancy >=12 weeks
- Adequate hematologic and end-organ function
- Negative HIV test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Negative total hepatitis B core antibody (HBcAb) test, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- Negative hepatitis C virus (HCV) antibody test, or positive HCV antibody test followed by a negative HCV RNA test at screening
- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggsduring the treatment period and for 5 months after the final dose of atezolizumab and for 6 months after the last dose of bevacizumab, carboplatin, or paclitaxel
- Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia
- Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection in the thighs
Additional inclusion criteria applicable to Part 1 only
- Histologically or cytologically documented NSCLC that is currently locally advanced or metastatic NSCLC
- Disease progression during or following treatment with a platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
- A body mass index between 18 and 32 kg/m2 inclusive
Additional inclusion criteria applicable to Part 2 only
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- Ability to send a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in paraffin block (preferred) or at least 7 or more unstained, freshly cut, serial sections on slides from an FFPE tumor specimen
- No prior treatment for Stage IV non-squamous NSCLC
- Treatment-free interval of at least 6 months since prior (neo) adjuvant chemotherapy, radiotherapy, or chemoradiotherapy
- Patients with a history of treated asymptomatic central nervous system (CNS) metastases are eligible
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm, with a female partner of childbearing potential who is not pregnantduring the treatment period and for 6 months after the final dose of bevacizumab, carboplatin, or paclitaxel (whichever is later)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 143
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 117

Exclusion Criteria

Parts1/ 2: Symptomatic,untr.,or actively progressing CNSmetastases -Spinal cord compression not definitively treated with surgery radiation,or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for>=2wks prior to enroll-History of leptomeningeal disease-Uncontrolled pleural effusion,symptomatic hypercalcemia,ericardial effusion,ascites requiring recurrent drainage proc.-History of malignancy other than NSCLC within 5years prior screening-History of sev anaphylactic reactions to chimeric/ humanized antibodies or fusion proteins-Known hypersensitivity to Chinese hamster ovary cell products or atezo-Active or history of autoimmune disease/immune deficiency/tuberculosis-History of idiopathic pulmonary fibrosis,organizing pneumonia/druginduced pneumonitis/idiopathic pneumonitis/evidence of active pneumonitis on screening chest computed tomography scan- Current treat with therapy for HBV-Severe infection within 4wks prior treat.-Treat. with therapeutic oral/IV antibiotics within 2wks prior treat.-Significant cardiovascular disease,within 3months prior treat.-Major surgical proc.,other than for diagnosis,within 4wks prior treat.,or anticipation of need for a major surgical proc.during the study-Prior allogeneic stem cell/solid organ transplantation-Treat. with a live,attenuated vaccine within 4wks prior treat.,or anticipation of need for such a vaccine during atezo treat.or within 5months after the final dose of atezo-Any other disease,metabolic dysfunction,physical examination finding,or clinical laboratory finding that contraindicates use of investigational drug,or that may affect the interpretation of the results,or may render the patient at high risk from treat.complications Related to Medications-Prior treat. withCD137 agonists or immune checkpoint blockade therapies,anti-PD-1,anti-PD-L1-Treat.with systemic immunostimulatory agents within 4wks or 5half-lives of the drug and systemic imunosuppressive medication within 2wks prior treat. Related to the SC Formulation-Known allergy/hypersensitivity to hyaluronidase,bee or vespid venom,or any other ingredient of rHuPH20.Part1 pathology that could interfere with any protocol-specified outcome assessment. Part2 Only-treat.with any approved anti-cancer therapy, including hormonal therapy,within 3wks prior and any other investing. agent with therapeutic intent within 28 days to initiation treat. Related to Bevacizumab-Inadequately controlled hypertension-Prior history hypertensive crisis or hypertensive encephalopathy -Significant vascular disease within 6 months prior to enrollment-History hemoptysis within 1month prior to enrollment-Evidence of active bleeding/bleeding diathesis/coagulopathy-Current or recent use of aspirin (>325mg/day) or treat.with dipyramidole,ticlopidine, clopidogrel,cilostazol and use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for >2wks prior to enrollment-Core biopsy or other minor surgical proc.,excluding placement of a vascular access device,within 7 days prior to the first dose of beva-History abdominal or tracheosphageal fistula/gastrointestinal perforation within 6months prior to enrollment-Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration,parenteral nutrition,tube feeding-Evidence of abdominal free air not explained by paracentesis or recent surgical proc.-Serious,non-healing wound,ac

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified