A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1 High Metastatic Non-Small Cell Lung Cancer

This is a multisite phase three, randomized, double-blind study for subjects with non-small-cell lung cancer (NSCLC). Approximately 830 patients will be enrolled into this study.

The standard of care options for NSCLC includes treatment with pembrolizumab that has been approved by the U.S. Food and Drug Administration (FDA).

This study is testing an experimental drug called rilvegostomig (also called AZD2936) and the purpose of this study is to learn more about the effectiveness and safety of the study drug rilvegostomig compared to pembrolizumab, a standard treatment option for this type of cancer. Also to better understand the studied disease metastatic lung cancer and associated health problems. One of the ways we will do this is to look at various measurable characteristics (biomarkers) in your body as indicators of health, disease or response to treatment.

This study is also testing the effectiveness of the diagnostic test used to assess the biomarker programmed death-ligand 1 (PD-L1) to identify metastatic NSCLC patients most likely to benefit from treatment with rilvegostomig. This is being conducted to support diagnostic approval in countries where required.

In order to participate you must meet the following criteria:

• Have histologically or cytologically documented non-small cell lung cancer (NSCLC), including all histological subtypes.
• Have stage IV metastatic non-small cell lung cancer (mNSCLC) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
• Have no presence of sensitizing epidermal growth factor receptor (EGFR) mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements. Negative assay result is required for all non-squamous histology subtypes.
  • Note: Testing should be carried out locally; if unavailable, central testing is allowed. Central testing results for EGFR, anaplastic lymphoma kinase (ALK) and/or ROS1 obtained during screening from another AstraZeneca study may be used.
• Have no presence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
  • Note: Testing for other genomic mutations is not mandated if not done as part of standard local practice.

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

• As judged by the investigator, have any severe or uncontrolled systemic diseases, including, but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; interstitial lung disease (ILD) (of any grade), serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease), active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment, psychiatric illness/social situations, substance abuse, or significant cardiac conditions which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
• Have a history of organ transplant.
• Have active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
• Have a history of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
• Have presence of small cell and neuroendocrine histology components.

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.