Priority Lists
Protocol Posting of
Activations
Activation - Effective 09/15/2025
Phase II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (CAPT-HN) Study Synopsis
| Action Codes | FBR |
| Study Coordinator(s) | Paul Swiecicki, M.D, |
| Participants | SWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING |
Activation-effective 05/15/2025
A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
| Action Codes | FBR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Michaela Liedtke, MD |
| Participants | SWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING |
Activation - Effective Date 9/08/2025
PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II studies evaluating maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)
| Action Codes | FBR |
Activation - Effective Date 9/08/2025
PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II studies evaluating maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)
| Action Codes | ER |
Activation - Effective Date 9/04/2025
Single Arm Phase II Study of Bladder Preservation with Immunoradiotherapy after a Clinically Meaningful Response to Neoadjuvant Therapy in Patients with Muscle Invasive Bladder Cancer (BRIGHT)
| Action Codes | FBR, NR |
| Study Coordinator(s) | Leslie Ballas, M.D., Siamak Daneshmand, M.D., Abhishek Tripathi, M.D., Daniel Hamstra, M.D., James Yu, M.D., Mark Tyson, MD, MPH, Kent Mouw, M.D., PhD, Joshua Meeks, M.D., David J. McConkey, Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Amendments, Revisions, Memoranda
Memorandum - LUNGMAP Updated Master Forms Set
A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
| Action Codes | NR |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #4 - Version Date 7/14/2025
Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials
| Action Codes | NR |
| Study Coordinator(s) | Jerald P. Radich, M.D. |
Memorandum - Specimen Tracking System Clarifications
Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials
| Action Codes | NR |
| Study Coordinator(s) | Jerald P. Radich, M.D. |
Memorandum - IND Safety Report(s) for BCG Tokyo – 172
A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
| Action Codes | ER |
| Study Coordinator(s) | Robert S. Svatek, M.D., Ajjai S. Alva, M.D., Seth P. Lerner, M.D., Joshua Meeks, M.D., Scott Gilbert, M.D., Rick Bangs |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Memorandum - IND Safety Report(s) for N-803 (ALT-803)
A Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
| Action Codes | ER |
| Study Coordinator(s) | John Wrangle, MD, MPH, Hatim Husain, MD |
Memorandum - IND Safety Report(s) for Daratumumab
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
| Action Codes | NR |
| Study Coordinator(s) | Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD |
Memorandum - IND Safety Report(s) for Sotorasib (AMG 510)
A PHASE II STUDY OF AMG 510 IN PATIENTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (ECOG-ACRIN LUNG-MAP SUB-STUDY)
| Action Codes | NR |
Revision #4 - Version Date 7/10/2025
A Randomized Phase II Study of INC280 (capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
| Action Codes | AC, ER |
| Study Coordinator(s) | Sarah B. Goldberg, MD, MPH, D. Ross Camidge, M.D., Ph.D |
| Participants | US INSTITUTIONS ONLY |
Revision #1 - Version Date 6/25/2025
A Phase II Study of Amivantamab SC (subcutaneous) in Participants Previously Treated with High MET-Amplification for Stage IV or Recurrent Non-Small-Cell Lung Cancer (Lung-MAP Sub-Study)
| Action Codes | IP, AC, ER, NR |
| Study Coordinator(s) | Shirish M. Gadgeel, M.D. |
| Participants | US INSTITUTIONS ONLY |
Memorandum - Updated Master Forms Set
A Phase II Study of Amivantamab SC (subcutaneous) in Participants Previously Treated with High MET-Amplification for Stage IV or Recurrent Non-Small-Cell Lung Cancer (Lung-MAP Sub-Study)
| Action Codes | IP, AC, ER, NR |
| Study Coordinator(s) | Shirish M. Gadgeel, M.D. |
| Participants | US INSTITUTIONS ONLY |
Memorandum - Updated Master Forms Set
A Randomized Phase II Study of Tepotinib with or Without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
| Action Codes | NR |
| Study Coordinator(s) | Paul Paik, M.D., Xiuning Le, M.D. |
| Participants | US INSTITUTIONS ONLY |
Memorandum - IND Safety Report(s) for Tazemetostat
Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapse/Refractory Large B-Cell Lymphoma
| Action Codes | ER |
| Study Coordinator(s) | Patrick Reagan, M.D., Alexey Danilov, M.D., Sonali Smith, M.D., Jennifer Amengual, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - IND Safety Report(s) for Daratumumab
A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma Patients Considered Frail or Ineligible for Stem Cell Transplant Comparing Frontline Regimen Bortezomib-Lenalidomide-Dexamethasone-Lite (VRd-Lite) with Daratumumab-Lenalidomide-Dexamethasone (DRd) Followed by Len+/-Dara (R+/-D) Maintenance
| Action Codes | NR |
| Study Coordinator(s) | Sikander Ailawadhi, M.D., Jing Christine Ye, M.D., MSc, Brea Lipe, MD |
Memorandum - IND Safety Report(s) for Daratumumab
A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
| Action Codes | NR |
Memorandum - Section 9.0 Clarification & Forthcoming Revision
Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)
| Action Codes | NR |
Memorandum - SWOG Pharmacy Committee Task Force – Initial Order Build Focus Group
Single Arm Phase II Study of Bladder Preservation with Immunoradiotherapy after a Clinically Meaningful Response to Neoadjuvant Therapy in Patients with Muscle Invasive Bladder Cancer (BRIGHT)
| Action Codes | FBR, NR |
| Study Coordinator(s) | Leslie Ballas, M.D., Siamak Daneshmand, M.D., Abhishek Tripathi, M.D., Daniel Hamstra, M.D., James Yu, M.D., Mark Tyson, MD, MPH, Kent Mouw, M.D., PhD, Joshua Meeks, M.D., David J. McConkey, Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Other New Items
- IP - Pts Must Be Informed
- AC - Consent Must Be Amended
- CBR - No Registration Allowed until IRB Review
- RC - Formal Re-consent Required
- FBR - Full Board Review Required
- ER - Expedited Review Acceptable
- NR - No IRB Review Required