A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 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 20 Insertion Mutation

UVA Tracking #
HSR230066
Principal Investigator
Ryan Gentzler
Contact
Contact Phone
Official Trial Title
A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 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
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutation. The purpose of this study is to assess the anti-tumor efficacy of DZD9008 (sunvozertinib), the study drug, versus platinum-based doublet chemotherapy (Pemetrexed combined with Carboplatin) in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation who are newly diagnosed or have not received prior systemic therapy for locally advanced or metastatic NSCLC. This is a randomized study. Patients taking part in this study will be randomly assigned (by chance, like the flip of a coin) to the study arms, and participants have equal chances of receiving the study drug or platinum-based doublet chemotherapy. Both you and the study doctor will know which kind of study treatment you are taking. This study also provides opportunities for participants who progress on the chemotherapy arm to cross-over to receive treatment with the study drug.

The length of your participation in this study will vary depending on how your body reacts to the study drug. You will receive the study drug via an oral tablet.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05668988?term=NCT05668988

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

You will be paid $65 per visit. Additionally, the study team may arrange for your hotel or you may be reimbursed by check up to $175 per night for a hotel.