NRG-LU004 PROTOCOL ACTIVATION AND TEMPORARY CLOSURE

 

NRG-LU004:  Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined With MEDI4736 (durvalumab) in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)

 

Effective January 4, 2019, NRG-LU004 will activate then temporarily close for modifications to the specimen collection logistics. This will be Amendment 1. 

ACTIVATION:

The NCI Central Institutional Review Board (CIRB) has approved this protocol.  Protocol documents can be obtained from the CIRB website at www.ncicirb.org.

 

Before registering patients on this trial, all IRB approvals must be submitted to the CTSU Regulatory Office via the Regulatory Submission Portal at www.ctsu.org (members’ area) > Regulatory Tab > Regulatory Submission.

 

Participating sites may obtain the Durvalumab Investigator Brochure from PMB/NCI. The current version of the IB is available via the CTEP Online Agent Order Processing (OAOP) website. Log-in using your CTEP IAM credentials, select the Investigator Brochures tab, and provide the requested information to access the IB. See Protocol Section 8 for all Registration and Study Entry Procedures.


TEMPORARY CLOSURE:

NRG Oncology is in the process of submitting an amended protocol to CTEP/CIRB to modify Section 10 and related Appendices describing specimen procedures. We will reopen the protocol and distribute the amendment to sites immediately upon CTEP/CIRB approval of the amendment. 

 

Please distribute this information to the appropriate personnel at participating affiliate institutions.


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