Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Inclusion Criteria:

* Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan
* Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:

  1. FL Gr 1, Gr 2, or Gr 3a
  2. MZL (splenic, nodal, or extra-nodal)
* Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
* Subjects must have at least one bi-dimensionally measurable lesion \>1.5 cm
* Adequate hematologic parameters at screening unless abnormal values are due to disease
* Adequate renal and hepatic function
* Adequate cardiac function based on ECG and LVEF assessments

Exclusion Criteria:

* Histologically confirmed diagnosis of FL Gr 3b or transformed disease
* Prior therapy with PI3K inhibitors
* Ongoing or history of drug-induced pneumonitis
* Known lymphomatous involvement of the central nervous system
* Tested positive for or active viral infection with hepatitis B or C virus
* Tested positive or active infection with human immunodeficiency virus
* Tested positive, or active infection with human T-cell leukemia virus type 1
* Any uncontrolled clinically significant illness
* History of clinically significant cardiovascular abnormalities such as congestive heart failure
* History of clinically significant gastrointestinal (GI) conditions
* Females who are pregnant