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DNA Damage Response Inhibitor

Novel Anti-Cancer Agents for Non-Small Cell Lung Cancer (HUDSON Trial)

Q: What are the primary medical applications for AZD6738?

<p>AZD6738 is frequently used to treat <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, but it also has other potential applications such as primary peritoneal cancer and Somatic Symptom Disorder.</p>

Phase 2

Waitlist Available

Led By John Heymach, M.D, Ph.D

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing

Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through to study completion, up to 4.5 years.

Awards & highlights

HUDSON Trial Summary

This trial is testing different treatments for people with NSCLC who have not responded to anti-PD-1/PD-L1 therapy. It is designed to assess the efficacy, safety, and tolerability of these treatments.

Who is the study for?

This trial is for adults with advanced NSCLC who've had disease progression after anti-PD-1/PD-L1 therapy and platinum-doublet chemotherapy. They should be in good physical condition, not pregnant or breastfeeding, willing to use birth control, and have no severe allergies to study drugs or history of certain immune disorders.Check my eligibility

What is being tested?

The trial tests multiple treatments like trastuzumab deruxtecan, cediranib, and others on patients with metastatic NSCLC post anti-PD-1/PD-L1 therapy failure. It's an open-label Phase II study assessing the efficacy and safety of these novel agents.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to treatment components, fatigue, nausea, risk of infection due to immune system impact from monoclonal antibodies used in some treatments.

HUDSON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My NSCLC is getting worse and has spread or come back.

Select...

I have at least one tumor that can be measured, including any that have grown after radiation.

Select...

I am mostly active and my doctor expects me to live at least 12 more weeks.

Select...

I am post-menopausal or not pregnant if pre-menopausal.

Select...

I am 18 years old or older.

HUDSON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through to study completion, up to 4.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through to study completion, up to 4.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through to study completion, up to 4.5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of the efficacy of each treatment by evaluation of objective response rate

Secondary outcome measures

Best percentage change in tumour size using RECIST 1.1 assessment for the anti-tumour activity of each therapy

Disease control rate (DCR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.

Duration of response (DoR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.

+2 more

Other outcome measures

Incidence of adverse events/serious adverse events to assess the safety and tolerability of each treatment

HUDSON Trial Design

11Treatment groups

Experimental Treatment

Group I: durvalumab + trastuzumab deruxtecanExperimental Treatment1 Intervention

durvalumab given in combination with trastuzumab deruxtecan (DS-8201a)

Group II: durvalumab + cediranibExperimental Treatment2 Interventions

durvalumab given in combination with cediranib (AZD2171)

Group III: durvalumab & AZD6738 (ceralasertib) (240 mg or 160 mg)Experimental Treatment1 Intervention

durvalumab in combination with twice daily 160 mg or 240 mg AZD6738 (D22-D28)

Group IV: durvalumab & AZD6738 (ceralasertib)Experimental Treatment2 Interventions

durvalumab given in combination with AZD6738 (D15-D28)

Group V: Durvalumab + vistusertibExperimental Treatment2 Interventions

Durvalumab given in combination with Vistusertib (AZD2014).

Group VI: Durvalumab + olaparibExperimental Treatment2 Interventions

Durvalumab given in combination with olaparib .

Group VII: Durvalumab + OleclumabExperimental Treatment2 Interventions

Durvalumab given in combination with Oleclumab

Group VIII: Durvalumab + AZD9150Experimental Treatment2 Interventions

Durvalumab given in combination with AZD9150.

Group IX: Durvalumab + AZD6738Experimental Treatment2 Interventions

Durvalumab given in combination with AZD6738.

Group X: AZD6738 (ceralasertib) monotherapyExperimental Treatment1 Intervention

AZD6738 (ceralasertib) given as monotherapy

Group XI: AZD6738 (ceralasertib) 7 days monotherapyExperimental Treatment1 Intervention

AZD6738 (ceralasertib) monotherapy on D1-7 of every 28 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cediranib

2011

Completed Phase 3

~140

Durvalumab

2017

Completed Phase 2

~3870

AZD9150

2018

Completed Phase 1

~120

AZD6738

2015

Completed Phase 2

~130

Olaparib

2007

Completed Phase 4

~2140

Oleclumab

2015

Completed Phase 2

~880

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,255 Total Patients Enrolled

John Heymach, M.D, Ph.DPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center

Media Library

AZD6738 (DNA Damage Response Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03334617 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: durvalumab & AZD6738 (ceralasertib) (240 mg or 160 mg), AZD6738 (ceralasertib) 7 days monotherapy, Durvalumab + olaparib, Durvalumab + AZD9150, Durvalumab + AZD6738, Durvalumab + vistusertib, Durvalumab + Oleclumab, durvalumab + trastuzumab deruxtecan, durvalumab + cediranib, AZD6738 (ceralasertib) monotherapy, durvalumab & AZD6738 (ceralasertib)

Non-Small Cell Lung Cancer Clinical Trial 2023: AZD6738 Highlights & Side Effects. Trial Name: NCT03334617 — Phase 2

AZD6738 (DNA Damage Response Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03334617 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been chosen to participate in this clinical trial?

"That is correct, the information available on clinicaltrials.gov indicates that this trial is still open for recruitment. The study was first posted on December 18th, 2017 and was last edited on September 29th, 2022. Up to 530 patients will be seen at 16 different locations."

Answered by AI

What is the status of AZD6738 in regards to government sanctioning?

"While there is some clinical data supporting the safety of AZD6738, it did not yet receive a score of 3 because efficacy has not been proven."

Answered by AI

Have similar trials been conducted in the past?

"Since 2005, AZD6738 has undergone 542 active trials in 2036 cities and 65 countries."

Answered by AI

Is recruitment for this clinical study currently underway?

"Yes, as indicated by clinicaltrials.gov, this trial is currently underway and recruiting patients. The study was first posted on December 18th, 2017 and has since been updated on September 29th, 2022. There are 16 sites participating in the trial, with a goal of enrolling 530 total participants."

Answered by AI

What are the primary medical applications for AZD6738?

"AZD6738 is frequently used to treat breast cancer, but it also has other potential applications such as primary peritoneal cancer and Somatic Symptom Disorder."

Answered by AI

Could I potentially enroll in this clinical research?

"Carcinoma patients that are non-small-cell lung cancer sufferers between the ages of 18 and 99 may be eligible for this trial, in which around 530 people will participate."

Answered by AI

At how many different hospitals is this clinical trial being conducted?

"There are a total of 16 clinical sites running this trial, which are situated in Duarte, Baltimore, Houston and other locations. If you enroll in the study, it is best to choose the center closest to your home to minimize travel."

Answered by AI

Can teenagers participate in this research study?

"Eligibility for this clinical trial starts at 18 years old and caps out at 99."

Answered by AI

Are there any other ongoing or completed research projects that focus on AZD6738?

"There are a total of 542 ongoing clinical trials for AZD6738, 84 of which have reached Phase 3. Many studies related to AZD6738 are situated in Los Angeles, though there are 23181 locations worldwide where these sorts of trials are taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

2017. "Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03334617.

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