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PD-L1 Inhibitor

Monalizumab or Oleclumab with Durvalumab and Radiation for Lung Cancer

Phase 1

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

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My body weight is over 30 kg.

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

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

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Experiencing a Safety Event

Secondary study objectives

Distribution of Participants by Highest Grade Adverse Event

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

Progression-free Survival

Other study objectives

Change in circulating tumor cells

Change in immune parameter

Descriptive statistics of biomarkers

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740