This study is assessing how safe and effective a new targeted therapy (called DZD9008) is compared to chemotherapy in people with locally advanced or metastatic non-small cell lung cancerA 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

Summary

This study is recruiting people with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy for their advanced disease.

Eligible particioants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive a new targeted therapy called DZD9008. DZD9008 is a selective EGFR tyrosine kinase (TKI) inhibitor, and will be administered orally at a dose of 300mg once daily.

In the Active Comparator Arm, participants will receive platinum-based doublet chemotherapy. Participants can receive up to 6 cycles of pemetrexed (500 mg/m2) + carboplatin area under the plasma concentration-time curve (AUC5) (5mg/ml per minute) as an IV infusion every 3 weeks as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met. 

Conditions

This trial is treating patients with non-squamous non-small cell lung cancer

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