A Phase 3, Open-Label, Randomized, Multi-Center Study ofDZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon

The purpose of this study is to see how safe the study drug, DZD9008, is, how it works, and assess the efficacy of the study drug verse standard treatment of your disease. DZD9008 is an investigational drug that has not been approved by United States Food and Drug Administration (FDA), for the treatment of NSCLC. Pemetrexed combined with Carboplatin is the standard treatment for advanced non-small cell lung cancer (NSCLC) with Exon 20 Insertion Mutation. The EGFR (epidermal growth factor receptor) is a gene that regulates cell growth and this gene can change, or mutate, in some people with NSCLC and cause a cancer to grow more rapidly. But not all EGFR mutations are the same, and one specific type is called EGFR exon 20 insertion mutation. People with this type of EGFR mutation don’t respond as well to therapies used to treat other kinds of EGFR changes in NSCLCs. In order to make the comparison between DZD9008 and chemotherapy as fair as possible, you will be randomly assigned (by chance; similar to drawing straws) to either receive the study drug or standard treatment.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years old or older - No major surgery within 4 wees of the first study drug administration - Women participants cannot be pregnant or breast feeding