CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Durvalumab +7 morebiological
Likely dose
Durvalumab 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03801902
NCT03801902Phase 1Completed

Phase I Trial of Radiotherapy Combined With Durvalumab Alone Plus Either Monalizumab or Oleclumab in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)

National Cancer Institute (NCI)·interventional·Posted Jan 14, 2019·Updated Sep 23, 2025

In Brief

A Phase 1 clinical trial evaluating Accelerated Hypofractionated Radiation Therapy, Biospecimen Collection, and 6 other interventions for Locally Advanced Lung Non-Small Cell Carcinoma and 4 related conditions. Completed, enrolled 26 participants across 56 sites.

Detailed Summary

This phase I trial studies the safety of adding durvalumab to accelerated hypofractionated radiation therapy (ACRT) or conventionally fractionated radiation therapy, as well as the safety of adding either monalizumab or oleclumab to durvalumab plus conventionally fractionated radiation therapy in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced). Accelerated hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Oleclumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD73, which is found on some types of tumor cells. Oleclumab may block CD73 and help the immune system kill tumor cells. It is not yet known whether adding durvalumab to ACRT or adding monalizumab or oleclumab to durvalumab plus conventionally fractionated radiation therapy will work better in treating patients with non-small cell lung cancer.

Study Details

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 14, 2019
Enrollment StartOct 28, 2019
Primary CompletionOct 26, 2021
Study CompletionSep 4, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.5 years ago

Interventions

Accelerated Hypofractionated Radiation Therapyradiation

160 Gy given as one 4 Gy fraction per day, 5 days per week for 15 fractions.

Biospecimen Collectionprocedure

Undergo collection of blood samples

Computed Tomographyprocedure

Undergo brain CT and chest CT

Durvalumabbiological

Administered intravenously (IV) as a 1500 mg fixed dose over 60 minutes for 13 cycles (1 cycle = 4 weeks), until disease progression or toxicity or death, whichever comes first.

Magnetic Resonance Imaging of the Brain with and without Contrastprocedure

Undergo brain MRI

Monalizumabbiological

Administered IV as a 1500 mg fixed dose over 60 minutes (+/- 10 minutes)

Oleclumabbiological

Administered IV 3000 mg over 60 minutes (+/- 10 minutes)

Radiation Therapyradiation

60 gy given as one 2 Gy fraction per day, 5 days per week for 30 fractions