JAVELIN: This phase III trial is comparing a chemotherapy drug (docetaxel) and an immunotherapy drug (avelumab) in patients with non-small cell (NSC) lung cancer that has gotten worse on prior treatmentA Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-small Cell Lung Cancer That Has Progressed After a Platinum-containing Doublet

Inclusion

• Signed written informed consent before any trial related procedure
• Male or female participants aged greater than or equal to (>=) 18 years
• Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
• Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
• Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression

• Participants must have progressed after an acceptable therapy defined as follows:

  1. Participants must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR
  2. Participants must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
• Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
• Estimated life expectancy of more than 12 weeks
• Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 × 10^9/L with absolute neutrophil count (ANC) >= 1.5 × 10^9/L, lymphocyte count >=0.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)
• Adequate hepatic function defined by a total bilirubin level less than or equal to (<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 × ULN for all participants
• Adequate renal function defined by an estimated creatinine clearance > 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method).

Other protocol defined inclusion criteria could apply