At a glance
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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)
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
Interventions
160 Gy given as one 4 Gy fraction per day, 5 days per week for 15 fractions.
Undergo collection of blood samples
Undergo brain CT and chest CT
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.
Undergo brain MRI
Administered IV as a 1500 mg fixed dose over 60 minutes (+/- 10 minutes)
Administered IV 3000 mg over 60 minutes (+/- 10 minutes)
60 gy given as one 2 Gy fraction per day, 5 days per week for 30 fractions