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DZD9008 for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates

1

Effectiveness

1

Safety

Non-Small Cell Lung Cancer+1 MoreDZD9008 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial will test a new drug on patients with advanced lung cancer who have progressed after other treatments. It will help to understand side effects and how well the drug works on its own.

Eligible Conditions

Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 1 Secondary · Reporting Duration: through the study completion, an average of around 1 year

Day 28

Part A: Safety and tolerability of DZD9008.

Day 28

Plasma DZD9008 concentration

Year 1

Part B: Objective Response Rate (ORR) according to RECIST 1.1.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1

IMU-201 (administered as PD1-Vaxx)

1

Cohort 2 - BNT116 + cemiplimab

1

Trial Design

9 Treatment Groups

DZD9008

1 of 9

Part A Dose expansion cohort 4 (Ongoing)

1 of 9

Part A Dose expansion cohort 5 (Ongoing)

1 of 9

Part A Dose expansion cohort 3

1 of 9

Part A Dose expansion cohort 2

1 of 9

Part A Dose expansion cohort 6

1 of 9

Part A Dose escalation

1 of 9

Part A Dose expansion cohort 1

1 of 9

Part B Dose extension (Ongoing)

1 of 9

Experimental Treatment

336 Total Participants · 9 Treatment Groups

Primary Treatment: DZD9008 · No Placebo Group · Phase 1 & 2

DZD9008

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part A Dose expansion cohort 4 (Ongoing)

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part A Dose expansion cohort 5 (Ongoing)

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part A Dose expansion cohort 3

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part A Dose expansion cohort 2

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part A Dose expansion cohort 6

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part A Dose escalation

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part A Dose expansion cohort 1

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Part B Dose extension (Ongoing)

Drug

Experimental Group · 1 Intervention: DZD9008 · Intervention Types: Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DZD9008

2021

Completed Phase 1

~80

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: through the study completion, an average of around 1 year

Who is running the clinical trial?

Dizal PharmaceuticalsLead Sponsor

13 Previous Clinical Trials

953 Total Patients Enrolled

Pasi Antero Janne, M.D & Ph. DPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?

Ohio	33.3%

Michigan	11.1%

Indiana	11.1%

Other	44.4%

What site did they apply to?

H. Lee Moffitt Cancer Center & Research Institute	25.0%

The Ohio State University Comprehensive Cancer Center	50.0%

Michigan Center of Medical Research	25.0%

What portion of applicants met pre-screening criteria?

Met criteria	66.7%

Did not meet criteria	33.3%

Why did patients apply to this trial?

"MY Doctor has indicated my SPA is elevated. Right now that's all I know"
"My 1 year older brother just died in December 2022 after they found mini cancer fells in his lungs plus then finding hundreds of mini cancer cells in his brain. They gave him 1-2 years to livr but he died 2 weeks later"

How many prior treatments have patients received?

0	66.7%

1	33.3%

References

2019. "Assessing an Oral EGFR Inhibitor, DZD9008 in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03974022.

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