DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab.

Eligibility criteria

Qualifiers

Sufficient understanding of nature of the trial and provision of informed consent with hand-written signatures and the date of signature prior to any study-specific procedures, sampling, and analyses.

Age ≥ 18 years.

Histologically or cytologically confirmed and locally advanced or metastatic non-squamous NSCLC.

Written documentation of EGFR mutations from an accredited local laboratory: Part A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.

Disqualifiers

Treatment with poziotinib, mobocertinib (TAK788), CLN-081, BDTX-189, aumolertinib, AP-L1898, and other EGFR Exon20ins inhibitors prior to the first dose of study drug (only applicable to Part B).

Prior treatment with 1st to 3rd generation EGFR-TKIs (e.g., gefitinib, erlotinib, icotinib, osimertinib, afatinib, dacomitinib, and ametinib) and have had an objective response (i.e., PR and CR) (only applicable to Part B).

Prior systemic treatment for locally advanced or metastatic NSCLC (only applicable to treatment naïve patients in Part B)

Treatment with EGFR, HER2, or VEGFR antibody within 4 weeks of the first dose of study drug.

Trial design

Treatments tested in this trial

  • DZD9008 plus Bevacizumab

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators