Phase 2 study for people with Lung Cancer

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

• Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
• Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
• Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

• Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
• Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids
• Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
• Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
• History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
• Active clinically significant infection requiring systemic therapy
• History of allogeneic tissue/solid organ transplant
• History of leptomeningeal disease
• Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
• Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• Untreated or symptomatic brain metastases
• Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
• Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention
• Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
• Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
• Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
• Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
• Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
• Part 1 only: Clinically significant corneal disease
• Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease