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Clinical Trials/EUCTR2015-003605-42-SK
EUCTR2015-003605-42-SKActive, not recruitingPhase 1

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

F. Hoffmann-La Roche Ltd0 sites578 target enrollmentStarted: March 4, 2016Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
578
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Male or female, 18 years of age or older
  • •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • •- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
  • •- Patients 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
  • •Patients with unknown EGFR and ALK status require test results at screening. ALK and/or EGFR may be assessed at a local or central laboratory.
  • •- Patients who have received prior neo-adjuvant, adjuvant chemotherapy,radiotherapy, 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
  • •- 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 < 1% per year during the treatment period and for at least 90 days after the last dose of study treatment
  • •- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
  • •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 374
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 194

Exclusion Criteria

  • •- Prior treatment with EGFR inhibitors or ALK inhibitors
  • •Cancer-Specific Exclusions
  • •- Active or untreated 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 >= 2 weeks prior to randomization
  • •- Leptomeningeal disease
  • •- Uncontrolled tumor-related pain
  • •- Uncontrolled or symptomatic hypercalcemia (> 1.5 millimole/Liter ionized calcium or calcium > 12 milligram/deciliter or corrected serum calcium > upper limit of normal)
  • •- Malignancies other than non-small cell lung cancer (NSCLC) within 5 years prior to randomization
  • •- Known tumor PD-L1 expression status from other clinical studies (e.g., patients 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
  • •- 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 within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • •Exclusion Criteria Related to Medications and Chemotherapy:
  • •- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
  • •- Prior treatment with 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
  • •- Patients with hearing impairment (cisplatin)
  • •- Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria (cisplatin)
  • •- Creatinine clearance (CRCL) =< 60 milliliter (mL)/minute (min) for cisplatin or < 45 mL/min for carboplatin

Investigators

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