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Comparing DZD9008 to standard chemotherapy for advanced lung cancer

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

Phase 3 Interventional Dizal Pharmaceuticals · NCT05668988

This study is testing if a new drug called DZD9008 can help people with advanced lung cancer and a specific genetic mutation feel better compared to standard chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorDizal Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy
Locations160 sites (Glendale, California and 159 other locations)
Trial IDNCT05668988 on ClinicalTrials.gov

What this trial studies

This phase 3, open-label, randomized, multi-center study evaluates the efficacy and safety of DZD9008 compared to platinum-based doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have an EGFR Exon20ins mutation. Approximately 320 participants will be randomized in a 1:1 ratio to receive either DZD9008 or standard chemotherapy, with the primary endpoint being progression-free survival assessed by independent central review. The study aims to provide insights into the effectiveness of DZD9008 as a treatment option for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with confirmed non-squamous NSCLC and an EGFR Exon20ins mutation who have not received prior systemic therapy.

Not a fit: Patients with prior systemic anti-cancer therapy for advanced NSCLC or those with concurrent EGFR mutations other than Exon20ins may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new targeted therapy option for patients with advanced NSCLC, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promising results with targeted therapies in NSCLC, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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 Criteria:

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).

Where this trial is running

Glendale, California and 159 other locations

+110 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.