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Anti-tumor antibiotic
DZD9008 vs Chemotherapy for Lung Cancer
Phase 3
Recruiting
Led By Caicun Zhou
Research Sponsored by Dizal Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
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
Must not have
History of stroke or intracranial hemorrhage within 6 months before randomization
Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
"This trial is comparing a new drug called DZD9008 to standard chemotherapy in patients with a type of lung cancer called NSCLC that has a specific genetic mutation. The study aims to see
Who is the study for?
This trial is for adults with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic therapy for their advanced disease. They must have a certain type of mutation in their cancer cells (EGFR Exon20ins), be able to perform daily activities with minimal assistance, and have a life expectancy of at least 12 weeks.
What is being tested?
The study compares DZD9008, an experimental drug, against standard platinum-based chemotherapy in patients with NSCLC carrying the EGFR Exon20ins mutation. Participants will be randomly assigned to one of these treatments and monitored to see which is more effective at slowing down cancer progression.
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, and organ-specific issues. The new drug DZD9008 may also cause unknown or unexpected side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My lung cancer is advanced but cannot be cured with surgery or radiation.
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My tumor tissue can be tested for a specific genetic change.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a stroke or brain bleed in the last 6 months.
Select...
My cancer has specific EGFR gene changes.
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I have not had systemic anti-cancer therapy for advanced NSCLC.
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I do not have cancer spread to my spinal cord or brain coverings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DZD9008Experimental Treatment1 Intervention
Group II: Platinum-based ChemotherapyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DZD9008
2023
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Dizal PharmaceuticalsLead Sponsor
25 Previous Clinical Trials
2,565 Total Patients Enrolled
Caicun ZhouPrincipal InvestigatorShanghai Pulmonary Hospital, Shanghai, China
14 Previous Clinical Trials
3,081 Total Patients Enrolled