Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1
Condition: Neoplasms
Intervention: Docetaxel; Feladilimab
Intervention description: Docetaxel was administered as IV infusion.; Feladilimab was administered as IV infusion.
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has
      assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC
      (Docetaxel) in participants with NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants capable of giving signed informed consent/assent.

          -  Male or female, aged 18 years or older at the time consent is obtained. Participants
             in Korea must be age 19 years or older at the time consent is obtained.

          -  Participants with histologically or cytologically confirmed diagnosis of NSCLC
             (squamous or non-squamous) and

             a) Documented disease progression based on radiographic imaging, during or after a
             maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent,
             Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must
             have been received in the same line or as separate lines of therapy: i) No more than
             or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than
             or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody
             (mAb) containing regimen.

             b) Participants with known BRAF molecular alterations must have had disease
             progression after receiving the locally available SoC treatment for the molecular
             alteration.

             c) Participants who received prior anti-PD(L)1 therapy must fulfill the following
             requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression
             (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not
             progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically
             or per RECIST 1.1 criteria

          -  Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.

          -  A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time
             of study entry is mandatory. Although a fresh tumor tissue sample obtained during
             screening is preferred, archival tumor specimen is acceptable.

          -  Adequate organ function as defined in the protocol.

          -  A male participant must agree to use a highly effective contraception during the
             treatment period and for at least 120 days after the last dose of study treatment and
             refrain from donating sperm during this period.

          -  A female participant is eligible to participate if she is not pregnant, not
             breastfeeding, and at least 1 of the following conditions apply:

             i) Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow
             the contraceptive guidance during the treatment period and for at least 120 days after
             the last dose of study treatment.

          -  Life expectancy of at least 12 weeks.

        Exclusion Criteria:

          -  Participants who received prior treatment with the following therapies (calculation is
             based on date of last therapy to date of first dose of study treatment):

               1. Docetaxel at any time.

               2. Any of the investigational agents being tested in the current study.

               3. Systemic approved or investigational anticancer therapy within 30 days or 5
                  half-lives of the drug, whichever is shorter. At least 14 days must have elapsed
                  between the last dose of prior anticancer agent and the first dose of study drug
                  is administered.

               4. Prior radiation therapy: permissible if at least one non-irradiated measurable
                  lesion is available for assessment per RECIST version 1.1 or if a solitary
                  measurable lesion was irradiated, objective progression is documented. A wash out
                  of at least 2 weeks before start of study drug for radiation of any intended use
                  is required.

          -  Received greater than (>)2 prior lines of therapy for NSCLC, including participants
             with BRAF molecular alternations.

          -  Invasive malignancy or history of invasive malignancy other than disease under study
             within the last 2 years, except

               -  Any other invasive malignancy for which the participant was definitively treated,
                  has been disease-free for at least 2 years and in the opinion of the principal
                  investigator and GlaxoSmithKline Medical Monitor will not affect the evaluation
                  of the effects of the study treatment on the currently targeted malignancy, may
                  be included in this clinical trial.

               -  Curatively treated non-melanoma skin cancer or successfully treated in situ
                  carcinoma.

          -  Carcinomatous meningitis (regardless of clinical status) and uncontrolled or
             symptomatic Central nervous system (CNS) metastases.

          -  Major surgery less than or equal to (<=) 28 days of first dose of study treatment.

          -  Autoimmune disease (current or history) or syndrome that required systemic treatment
             within the past 2 years. Replacement therapies which include physiological doses of
             corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency)
             are not considered systemic treatments.

          -  Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or
             other immunosuppressive agents within 7 days prior to first dose of study treatment.

          -  Prior allogeneic/autologous bone marrow or solid organ transplantation.

          -  Receipt of any live vaccine within 30 days prior to first dose of study treatment.

          -  Toxicity from previous anticancer treatment that includes:

               1. Greater than or equal to (>=) Grade 3 toxicity considered related to prior
                  immunotherapy and that led to treatment discontinuation.

               2. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except
                  alopecia, hearing loss, endocrinopathy managed with replacement therapy, and
                  peripheral neuropathy which must be <= Grade 2).

          -  History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past-
             pneumonitis exclusion only if steroids were required for treatment), interstitial lung
             disease, or organizing pneumonia.

          -  Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural
             or pericardial effusions.

          -  Recent history (within the past 6 months) of gastrointestinal obstruction that
             required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal
             abscess.

          -  History or evidence of cardiac abnormalities within the 6 months prior to enrollment
             which include

               1. Serious, uncontrolled cardiac arrhythmia or clinically significant
                  electrocardiogram abnormalities including second degree (Type II) or third degree
                  atrioventricular block.

               2. Cardiomyopathy, myocardial infarction, acute coronary syndromes (including
                  unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.

               3. Symptomatic pericarditis.

          -  Current unstable liver or biliary disease per investigator assessment defined by the
             presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or
             gastric varices, persistent jaundice, or cirrhosis.

          -  Active infection requiring systemic therapy <=7 days prior to first dose of study
             treatment.

          -  Participants with known human immunodeficiency virus infection.

          -  Participants with history of severe hypersensitivity to mAb or hypersensitivity to any
             of the study treatment(s) or their excipients.

          -  Participants requiring ongoing therapy with a medication that is a strong inhibitor or
             inducer of the cytochrome P 3A4 (CYP3A4) enzymes.

          -  Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric
             disorder, or other condition that could interfere with participant's safety, obtaining
             informed consent, or compliance to the study procedures in the opinion of the
             investigator.

          -  Pregnant or lactating female participants.

          -  Participant who is currently participating in or has participated in a study of an
             investigational device within 4 weeks prior to the first dose of study treatment.

          -  Participants with presence of hepatitis B surface antigen (HBsAg) at screening or
             within 3 months prior to first dose of study intervention.

          -  Participants with positive hepatitis C antibody test result at screening or within 3
             months prior to first dose of study intervention.

          -  Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening
             or within 3 months prior to first dose of study treatment.

          -  Receipt of transfusion of blood products (including platelets or red blood cells) or
             administration of colony-stimulating factors (including granulocyte colony stimulating
             factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant
             erythropoietin) within 14 days before the first dose of study intervention.