Study of Sacituzumab Govitecan Combinations in First-Line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer

This is an open-label, multicenter, phase 2 study for subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Approximately 164 patients will be enrolled into this study. 

The standard of care options for non-small cell lung cancer (NSCLC) include chemotherapy. 

This study is testing an experimental drug called Sacituzumab Govitecan in combination with pembrolizumab or with pembrolizumab and a platinum agent and the purpose of this study is to better understand how the disease responds to treatment with sacituzumab govitecan in combination with immunotherapy (pembrolizumab) or chemotherapy (carboplatin or cisplatin) in patients with non-small cell lung cancer (NSCLC).

Other purposes of this study include determining the safest dose of sacituzumab govitecan for treatment of NSCLC, and the timeline of how long the disease is at a stable level.

In order to participate you must meet the following criteria:

• Are a female or male patient, 18 years of age or older.
• Are able to understand and give written informed consent.
• Have a life expectancy ≥ 3 months.
• Have Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria by investigator.
  • Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator. 4) Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria by investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator.

You will be excluded from the study if any of the following criteria apply to you:

• Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
• Have active second malignancy.
• Have NSCLC that is eligible for definitive local therapy alone.
• Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Intermittent use of topical, inhalational, intranasal, and intraocular steroids is permitted.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.