Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing DZD6008 for Non-Small Cell Lung Cancer

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment.

Official registry: https://clinicaltrials.gov/study/NCT07079475 · Dizal Pharmaceuticals · enrollment listed as 220

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are DZD6008, Sunvozertinib, or Osimertinib. The registry lists allocation as randomized. This study will treat patients with advanced NSCLC harboring EGFR mutations.

They plan to enroll about 220 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

Interventions: DZD6008, Sunvozertinib, Osimertinib

Primary outcome (registry wording): Part A: To assess safety and tolerability

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced or metastatic, not suitable for curative therapy
  • Documentation of EGFR mutation from a local certified laboratory. Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins). Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations
  • ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks
  • Brain metastases must be stable at study entry
  • Measurable disease per RECIST 1.1
  • Adequate hematopoietic and other organ system functions

Public study contact (from the registry)

YIFAN LIU

(86) 021-61095854

yifan.liu@dizalpharma.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

14 listed

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FAQ about this NCT record

Is NCT07079475 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07079475?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07079475?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary