SHS_492318 WESH CGEN 15287

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

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 non-small cell lung cancer (NSCLC).

Select Inclusion Criteria (see for more information):

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.
No prior treatment for Stage IV non-squamous NSCLC.
Participants who have received prior neo-adjuvant, 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 chemotherapy or completion of chemoradiotherapy.
Known programmed death-ligand 1 (PD-L1) tumor status as determined by archival tumor tissue or tissue obtained from a biopsy at screening.
Measurable disease.
Adequate hematologic and end organ function.

Select Exclusion Criteria (see for more information):

Active or untreated central nervous system (CNS) metastases.
Spinal cord compression not definitively treated 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 or symptomatic hypercalcemia.
Malignancies other than NSCLC within 5 years prior to randomization.
Known tumor PD-L1 expression status from other clinical studies.
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.
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.
History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds.
Participants with hearing impairment (cisplatin).
Grade >= 2 peripheral neuropathy.
Creatinine clearance (CRCL) =< 60 milliliter (mL)/minute (min) for cisplatin or < 45 mL/min for carboplatin.
Phase III
Howard (Jack) West, M.D.
Andrew Smith
  • Swedish Medical Center