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RecruitingLast updated: 26 February 2024

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

Clinical summary

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

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Dizal Pharmaceuticals

Scientific 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 20 Insertion Mutation

Eligibility

Inclusion

  1. Aged at least 18 years old (or per local regulatory/IRB requirement).
  2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
  3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
  4. At least 1 measurable lesion per RECIST Version 1.1
  5. Life expectancy ≥ 12 weeks
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  7. Adequate organ and hematologic function

Exclusion

  1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
  2. Spinal cord compression or leptomeningeal metastasis.
  3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
  4. History of stroke or intracranial hemorrhage within 6 months before randomization.
  5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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