Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors

Summary: The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.


Eligibility: Inclusion Criteria:
  -  Histologic or cytologic confirmation of advanced solid tumor.
  -  For monotherapy, no prior treatment with a PD-1 or PD-L1 agent is allowed.
  -  For LY3300054 combination therapy, previous immunotherapy is acceptable, if the following criteria are met:
  -  Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
  -  Must have completely recovered or recovered to baseline prior to screening from any prior adverse events (AEs) occurring while receiving prior immunotherapy.
  -  Must not have experienced a Grade ≥3 immune-related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy.
  -  Must not have required the use of additional immunosuppressive agents other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of >10 milligrams prednisone or equivalent per day.
  -  Have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  -  Have adequate organ function.
  -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Have submitted a tumor tissue sample, as follows:
  -  For participants entering the Phase 1a dose escalation: have submitted, if available, an archival tumor tissue sample.
  -  For participants participating ONLY in the Phase 1b expansion: have submitted tissue sample from either a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy, defined by ≤3 years since last documented progression of disease.
  -  Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.
  Exclusion Criteria:
  -  Have a serious concomitant systemic disorder including human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorder or disease requiring high dose of steroids.
  -  Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea.
  -  Have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis.
  -  Have an active infection requiring systemic therapy.
  -  Have moderate or severe cardiovascular disease.
  -  Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment.
  -  Have received a live vaccine within 30 days before the first dose of study treatment.

Relevance to patient case: not relevant