NRG-LU004
Terminated
Protocol Information
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)
Principal Investigator
Status
Terminated
Temporarily Closed to Accrual
January 4, 2019
Open to Accrual
March 6, 2019
Temporarily Closed to Accrual
April 13, 2020
Open to Accrual
July 16, 2020
Closed to Accrual
June 21, 2021
Temporarily Closed to Accrual
June 21, 2021
Open to Accrual
January 5, 2024
Temporarily Closed to Accrual
October 8, 2024
Closed to Accrual
December 12, 2024
Closed to Accrual & Treatment
December 12, 2024
Complete
September 4, 2025
Terminated
September 4, 2025
Disease Site
Lung [LU] Non-small Cell Lung Cancer
Phase
I
Developmental Therapeutics
No
Primary Objective
To evaluate if the addition of MEDI4736 (durvalumab) to two schedules of radiation therapies (60 Gy in 30 fractions or 60 Gy in 15 fractions) is safe.
Patient Population
Unresectable or inoperable, non-metastatic stage II-III Non-Small Cell Lung Cancer patients who have PD-L1 high expressing tumors (>=50%) within 60 days prior to registration.
Target Accrual
24
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
- NRG-LU004-Study-Memorandum-Amendment-3-September-14-2020.pdf
- NRG-LU004-Amendment-2-Study-Memorandum-December-23-2019.pdf
- NRG-LU004-Study-Memorandum-Activation-January-4-2019.pdf
- NRG-LU004-Study-Memorandum-Amendment-1-March-6-2019.pdf
- NRG-LU004-Study-Memorandum-Cohort-1_January-22-2020.pdf
- NRG-LU004-Study-Memorandum-Cohort-2_April-13-2020.pdf
- NRG-LU004-Study-Memorandum-Reopening_July-16-2020.pdf
- NRG-LU004-Study-Memorandum-Amendment-4-February-8-2021.pdf
- NRG-LU004-Study-Memorandum-Closure-June-21-2021.pdf
- NRG-LU004-Study-Memorandum-Amendment-5-November-29-2021.pdf
- NRG-LU004-Study-Reopening-Memorandum_January-5-2024.pdf
- NRG-LU004-Study-Memorandum-Amendment-7-June-18-2024.pdf
- NRG-LU004-Temporary-Accrual-Suspension-Memorandum_October-8-2024.pdf
- NRG-LU004-Study-Memorandum-Permanent-Closure_December-12-2024.pdf
- 0279-Amendment-2-tracked.pdf
- Durvalumab-Tremelimumab-Posted-7-8-19-1.pdf
- Durvalumab-Tremelimumab-Posted-5-28-19.pdf
- Durvalumab-Tremelimumab-Posted-5-13-19-1.pdf
- Durvalumab-Tremelimumab-Posted-4-29-19.pdf
- Durvalumab-Tremelimumab-Posted-4-8-19.pdf
- Durvalumab-Posted-1-20-20.pdf.pdf
- Pembrolizumab-Posted-2-3-20.pdf
- Durvalumab-posted-2-10-20.pdf
- Durvalumab-Posted-2-3-20-1.pdf
- Durvalumab-Posted-4.3.2020-2.pdf
- Durvalumab-Posted-4.6.2020.pdf
- Durvalumab-Posted-9.28.20.pdf
- Durvalumab-Posted-10.19.20.pdf
- Durvalumab-Posted-11.12.20.pdf
- Durvalumab-2-Posted-11.12.20.pdf
- Durvalumab-Posted-12.14.20-2.pdf
- Durvalumab-Posted-12.14.20.pdf
- MEDI4736-durvalumab-Posted-2.15.21.pdf
- MEDI4736-Durvalumab-Posted-3.22.21.pdf
- Durvalumab-AE-2892141_5-20-2021-FU1-posted-6-7-2021-.pdf
- Durvalumab-AE-2327633_5-26-2021-FU-1-posted-6-14-2021.pdf
- Durvalumab-Protocol_5-19-2021-AE-2327633-ISR-posted-6-21-2021.pdf
- Posted-8.6.21-Durvalumab-AE-2187690_6-23-2021-FU-1.pdf
- Posted-8.6.21-Durvalumab-AE-2381107_7-20-2021-FU2.pdf
- Posted-8.12.21-Durvalumab-AE-2546670_7-16-21-FU2.pdf
- Durvalumab-AE-2884459_10-12-2021-FU-1-POSTED-11.11.21.pdf
- Durvalumab-AE-2271621_-9-30-2021-FU-1-POSTED-11.11.21.pdf
- Durvalumab-AE-2302721_10-18-2021-ISR-POSTED-11.11.21.pdf
- 12.3.21-Durvalumab-AE-2311488_-11-9-2021-FU-1.pdf
- Mar.3.2022.Durvalumab-AE-2084961_11-23-2021-ISR.pdf
- Mar.3.2022.Durvalumab-AE-2311488_-11-22-2021-FU-2.pdf
- Mar.3.2022.Durvalumab-AE-2339245_11-30-2021-ISR.pdf
- Mar.3.2022.Durvalumab-AE-2339245_12-16-2021_FU-1.pdf
- Durvalumab-AE-2785251_-8-17-2021-ISR.pdf
- Durvalumab-AE-2143290_-2-24-2022-FU-1.pdf
- Durvalumab-AE-2210569-Protocol-EA5181-FU-1.pdf
- Durvalumab-AE-2524563_3-8-2022-ISR.pdf
- Durvalumab-AE-2544523-Protocol-EA5181-FU-1.pdf
- Durvalumab-AE-2846421-Protocol-10292-ISR.pdf
- Durvalumab-AE-2570504-Protocol-EA5181-ISR.pdf
- Durvalumab-AE-2544523-Protocol-EA5181-ISR.pdf
- Durvalumab-AE-2524563_3-23-2022_FU-1.pdf
- Durvalumab-AE-2504280-6-7-2022_ISR.pdf
- Durvalumab-AE-2332948-5-11-2022_FU-1.pdf
- Durvalumab-AE-2568412_-6-29-2022_-FU-1.pdf
- Durvalumab-AE-2507908_July-5-2022-ISR.pdf
- Durvalumab-AE-2504280_-6-27-2022_-FU-1.pdf
- Durvalumab-AE-2306550_7-21-2022_-ISR.pdf
- Durvalumab-AE-2349866_8.1.22-ISR.pdf
- Durvalumab-AE-2585323_8.26.22-ISR.pdf
- Durvalumab-AE-2349866_8-15-22_FU1.pdf
- Durvalumab-AE-2923721_-Nov-14-2022-ISR.pdf
- Cediranib-and-Durvalumab-AE-2010228_2-2-2023-FU-1.pdf
- Durvalumab-MEDI4736-AE-2954137_-12-27-2022_FU-2.pdf
- Durvalumab-AE-2485295_-1-12-2023_-FU-1.pdf
- Durvalumab-AE-2119908_2-1-2023_-ISR.pdf
- Durvalumab-AE-2485295_-1-31-2023_FU-2.pdf
- Durvalumab-AE-2904734_12-30-2022_FU-1.pdf
- Cediranib-Durvalumab-and-Olaparib-AE-2881237_-3-21-2023_FU-1.pdf
- Durvalumab-AE-2022243_4-4-2023-FU-1.pdf
- Durvalumab-AE-2222952_4-11-2023_FU-1.pdf
- Durvalumab-MEDI4736-AE-2904734_5.4.23_-FU2.pdf
- Durvalumab-AE-2022243_5.4.2023_-FU-2.pdf
- Durvalumab-AE-2209066_6.11.2023_FU-1.pdf
- Durvalumab-AE-2056619_11-6-23_FU-1.pdf
- Durvalumab-AE-2130771_8.10.23_FU-1.pdf
- Durvalumab-AE-2130771_8.21.23-FU-2.pdf
- Durvalumab-AE-2209066_6-13-2023-FU-2.pdf
- Durvalumab-AE-22441002_7-11-2023-FU-2.pdf
- Durvalumab-AE-2297205_8.18.23_-FU-1.pdf
- Durvalumab-AE-2889959_6-16-2023-ISR.pdf
- Durvalumab-AE-2904734_6-23-2023-FU3.pdf
- Durvalumab.-AE-2297205-Protocol-EA5181-FU-2.pdf