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New treatment option for Non Small Cell Lung Cancer
Official title A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
ClinicalTrials.gov ID: NCT06905197
What this study is testing
What is DZD6008?
DZD6008 is an investigational medicine, given as an once-daily, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be able to provide documented informed consent.
- Aged ≥ 18 years.
- Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.
- Documentation of EGFR mutations from a local CLIA-certified laboratory (or equivalent). For Part A monotherapy cohorts and all cohorts of Part B...
- Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment. (previously treated...
You likely can't join if
- Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions...
- NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.
- Prior treatment with any of the following: 1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 2)Any...
- Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.
- Spinal cord compression or leptomeningeal metastasis.
- Patients with any other malignancy within 2 years of the first administration of study drug.
See the full eligibility criteria
- Patients must be able to provide documented informed consent.
- Aged ≥ 18 years.
- Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.
- Documentation of EGFR mutations from a local CLIA-certified laboratory (or equivalent). For Part A monotherapy cohorts and all cohorts of Part B, EGFR sensitizing mutations (Exon19del and/or L858R) are required.
- Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment. (previously treated patients) or before study treatment (treatment naïve patients).
- Part A: Failed (progressed or are intolerant) from at least 1 prior EGFR TKI regimen. Cohort A of Part B: Failed 1 prior third-generation EGFR TKI regimen. Cohorts B of Part B: Patients who are treatment naïve.
- ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.
- Patients with brain metastases must have a stable BM status.
- Measurable disease per RECIST 1.1.
- Adequate hematopoietic and other organ system functions.
- Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the...
- Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B).
- NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.
- Prior treatment with any of the following: 1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a...
- Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.
- Spinal cord compression or leptomeningeal metastasis.
- Patients with any other malignancy within 2 years of the first administration of study drug.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.
- Patients with active infection, including but not limited to HBV, HCV, HIV and active infection of COVID-19.
- Resting QTcF \> 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.
- Past medical history of ILD or active ILD.
- Diseases which would preclude adequate absorption of DZD6008.
- Received a live vaccine within 2 weeks before the first administration of DZD6008.
- Women who are pregnant or breastfeeding.
- Hypersensitivity to active or inactive excipients of DZD6008 or sunvozertinib.
- Involvement in the planning and conduct of the study.
- Judgment by the investigator that the patient is unlikely to comply with study procedures
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Fairfax, Virginia, United States
- Blacktown, New South Wales, Australia
- Camperdown, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Fairfax, Virginia, United States; Blacktown, New South Wales, Australia; Camperdown, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.