← Back to Search

PD-L1 Inhibitor

Durvalumab for Lung Cancer

Q: What indications does Durvalumab have as a treatment option?

<p>Unresectable stage III non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> is typically treated with Durvalumab, however this medication has also been used to address previously untreated metastatic urothelial carcinoma and advanced directives.</p>

Phase 1

Recruiting

Led By Steven H Lin

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Body weight > 30 kg

Pathologic (cytological or histological) proof of diagnosis of stage II-III (American Joint Committee on Cancer [AJCC] 8th edition [ed.]) unresectable or inoperable, non-metastatic non-small cell lung cancer (NSCLC) within 60 days prior to registration, with no liver or renal end organ damage, as determined by normal laboratory values noted below. Locally recurrent, N1-N3 disease following surgery without prior radiation therapy is eligible. Patients with N1 to N3 and undetectable primary lung tumors (T0) are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration to 3 years (approximately 2 years after end of treatment).

Awards & highlights

Study Summary

This trial is testing two different radiation schedules with durvalumab to see which is better at treating NSCLC.

Who is the study for?

This trial is for adults with stage II-III non-small cell lung cancer (NSCLC) that can't be removed by surgery. They must have a specific level of tumor protein called PD-L1, good organ function, and no liver or kidney damage. Participants need to be physically able to undergo the treatments (ECOG 0-2), have sufficient lung function, and weigh over 30 kg.Check my eligibility

What is being tested?

The ARCHON-1 trial is testing if adding durvalumab to standard radiation therapy improves outcomes in NSCLC patients. It's also comparing the effects when either monalizumab or oleclumab are added into this treatment mix. The study will look at different doses of radiation and how well these combinations work together.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, potential impact on blood cells leading to increased infection risk or bleeding problems, as well as typical radiation therapy side effects like skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

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

Select...

My body weight is over 30 kg.

Select...

My lung cancer is at stage II-III, cannot be removed by surgery, and has not spread to my liver or kidneys.

Select...

My tumor has a high PD-L1 expression, tested within the last 2 months.

Select...

My lung function is good, meeting the required breathing test standards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to 3 years (approximately 2 years after end of treatment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to 3 years (approximately 2 years after end of treatment).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to 3 years (approximately 2 years after end of treatment). for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants Experiencing a Safety Event

Secondary outcome measures

Distribution of Participants by Highest Grade Adverse Event

Percentage of Participants Experiencing a Grade 4 or Higher Non-hematologic Adverse Event

Percentage of Participants Who Received at Least 80% of Planned Dose of Monalizumab or Oleclumab During the First 8 Weeks Following the Initial Dose

+2 more

Other outcome measures

Change in circulating tumor cells

Change in immune parameter

Descriptive statistics of biomarkers

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm IV (durvalumab, oleclumab, standard RT)Experimental Treatment6 Interventions

Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Patients also receive oleclumab IV over 60 minutes on days 1 and 15 of cycles 1-2, then on day 1 of cycles thereafter. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.

Group II: Arm III (durvalumab, monalizumab, standard RT)Experimental Treatment6 Interventions

Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes and monalizumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.

Group III: Arm II (CLOSED) (Durvalumab and standard RT)Experimental Treatment5 Interventions

Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.

Group IV: Arm I (CLOSED) (Durvalumab and ACRT)Experimental Treatment5 Interventions

Starting 2 weeks prior to radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ACRT 1 fraction per day, 5 days per week for 15 fractions. Patients also undergo brain MRI or CT scan during screening and as clinically indicated, chest CT scans on study and during follow up, and collection of blood samples during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oleclumab

2015

Completed Phase 2

~880

Monalizumab

2019

Completed Phase 2

~250

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Durvalumab

2017

Completed Phase 2

~3870

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,224 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,804 Total Patients Enrolled

Steven H LinPrincipal InvestigatorNRG Oncology

2 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

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

What indications does Durvalumab have as a treatment option?

"Unresectable stage III non-small cell lung cancer is typically treated with Durvalumab, however this medication has also been used to address previously untreated metastatic urothelial carcinoma and advanced directives."

Answered by AI

Is this study presently accepting new participants?

"At the current moment, this clinical trial is not enrolling participants. Initially posted on April 1st 2019 and most recently updated July 22nd 2022, patient recruitment has temporarily ceased. However, there are 4163 studies actively recruiting patients with stage iib lung cancer ajcc v8 as well as 333 trials for Durvalumab that may be of interest."

Answered by AI

Does the administration of Durvalumab pose any health risks?

"The safety of Durvalumab has been assessed at a level 1 by the Power team, given that this is still in its preliminary stages and there are limited results to back up effectiveness and protection."

Answered by AI

What is the primary purpose of this experiment?

"This trial will span up to two years and hopes to determine the number of participants that suffer safety events. Secondary objectives include evaluating adverse effects (utilizing Common Terminology Criteria for Adverse Events version 5.0), assessing how many patients received at least 80% of their durvalumab dose, and determining progression free survival as defined by RECIST 1.1 guidelines through Kaplan-Meier analysis."

Answered by AI

What is the numerical scope of individuals enrolled in this research endeavor?

"This investigation is no longer recruiting patients. Initially posted on April 1st 2019, and most recently changed July 22nd 2022; those seeking alternate trials may be interested to know that there are 4163 clinical trials actively enrolling participants with stage iib lung cancer ajcc v8 and 333 studies for Durvalumab in progress as of now."

Answered by AI

In what number of health facilities is this experiment being conducted?

"Patients for this trial can register at the UM Upper Chesapeake Medical Center in Bel Air, MD Anderson West Houston located in Houston or Wayne State University/Karmanos Cancer Institute situated in Detroit. Additionally, there are 58 other medical centres offering participation."

Answered by AI

Are there precedents of Durvalumab being used in other research studies?

"Presently, 333 clinical studies exploring the efficacy of Durvalumab are in progress. Out of those trials, 52 have entered Phase 3. Though many trials for this medication occur near Pilar, Florida there are 12959 locations worldwide running such experiments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), The ARCHON-1 Trial

2019. "Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), The ARCHON-1 Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03801902.

All > Paid Studies Montana