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
Brief description of study
This study is being conducted to determine how safe and effective a drug called DZD9008 is compared to standard chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertions in the first-line setting. The main goal of the study is to determine if DZD9008 is better than chemotherapy in terms of how long the cancer can be controlled by the treatment without getting worse. Eligible patients will be randomly assigned to receive either DZD9008 or chemotherapy. Patients in the DZD9008 group will continue taking the drug as long as it is beneficial, as determined by their doctor. Patients in the chemotherapy group will receive a specific combination of drugs (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) for up to six cycles, and if their disease does not progress, they may continue with a different drug (pemetrexed maintenance monotherapy). Patients will be followed until their cancer gets worse, and various assessments will be conducted throughout the study. The study will also evaluate the impact of DZD9008 on the patients' quality of life.
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