A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

Part of paid clinical trials in New York, New York.

Sponsor
Dizal Pharmaceuticals
Study ID
NCT06905197
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DZD6008 — DRUG
    Daily dose of DZD6008
  • Sunvozertinib — DRUG
    Daily dose of Sunvozertinib

Study Details

This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.

Key Dates

Start date
May 13, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Part A Dose Escalation monotherapy cohorts (20 mg once daily [QD])
  • Experimental: Experimental: Part A Dose Escalation monotherapy cohorts (40 mg QD)
  • Experimental: Experimental: Part A Dose Escalation monotherapy cohorts (60 mg QD)
  • Experimental: Experimental: Part A Dose Escalation monotherapy cohorts (90 mg QD)
  • Experimental: Experimental: Part A Dose Escalation monotherapy cohorts (120 mg QD)
  • Experimental: Experimental: Part A Dose Escalation monotherapy cohorts (150 mg QD)
  • Experimental: Experimental: Experimental: Part A Dose Escalation Combination cohorts (Combination dose 1)
  • Experimental: Experimental: Experimental: Part A Dose Escalation Combination cohorts (Combination dose 2)
  • Experimental: Experimental: Part A Dose Escalation Combination cohorts (Combination dose 3)
  • Experimental: Experimental: Part B Dose Expansion cohort A1 (selected dose 1)
  • Experimental: Experimental: Experimental: Part B Dose Expansion cohort A2 (selected dose 2)
  • Experimental: Experimental: Experimental: Part B Dose Expansion cohort B1 (selected dose 1)
  • Experimental: Experimental: Experimental: Part B Dose Expansion cohort B2 (selected dose 2)

Primary Outcome Measure

Part A: To assess safety and tolerability [ Time Frame: 21 days after the first multiple dose ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032
Shu
[email protected]
(212) 305-3997
Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Shum
[email protected]
1-347-978-5004
Virginia Cancer Specialist (NEXT Oncology-Virginia)FairfaxVirginia22031-

Find similar trials in New York, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Herbert Irving Comprehensive Cancer Center· New York, NYLaura and Isaac Perlmutter Cancer Center at NYU Langone Health· New York, NYVirginia Cancer Specialist (NEXT Oncology-Virginia)· Fairfax, VA

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