Trial & Business Updates:

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Amendments, Revisions, Memoranda

21CTP.HN01Phase II

Memorandum - Protocol CSTD Guidance and Protocol Windows Update

Phase II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (CAPT-HN) Study Synopsis
Action CodesNR
Study Coordinator(s)Paul Swiecicki, M.D,
ParticipantsSWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING

Memorandum - Fall 2026 Lung-MAP Update Forum materials

A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Action CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1316Phase III

Memorandum - Participant-Friendly Trial Results Materials

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Action CodesNR
Study Coordinator(s)Robert S. Krouse, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

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 CodesNR
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 CodesNR
Study Coordinator(s)Sukhmani K. Padda, M.D., David Gerber, M.D.
S2005Phase II Intergroup

Memorandum - IND Safety Report(s) for Ibrutinib (PCI-32765)

A PHASE II RANDOMIZED STUDY COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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 CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D., Jing Christine Ye, M.D., MSc, Brea Lipe, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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 CodesNR
S2419Phase II-III

Memorandum - New S2419 October 2026 Kick Off Meeting Video Now Available

Phase II/III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic MO-03, or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma (BioFront Trial)
Action CodesNR
Study Coordinator(s)Pedro Barata, M.D., Ulka N. Vaishampayan, M.D., Sumanta K. Pal, M.D., David J. McConkey, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 1 of 2 - Patient Reported Outcome Forms (Spanish)

A Randomized Controlled Trial of an Intervention called Algorithm-Enabled Patients Activated in Cancer Care through Teams (A-PACT) to Improve Goals of Care Communication for People with Cancer
Action CodesER, NR
Study Coordinator(s)Ravi Parikh, M.D., Manali Patel, M.D.
ParticipantsLimited: SWOG NCORP Cancer Care Delivery Research (CCDR) Components

Memorandum 2 of 2 - Updated Master Forms Set

A Randomized Controlled Trial of an Intervention called Algorithm-Enabled Patients Activated in Cancer Care through Teams (A-PACT) to Improve Goals of Care Communication for People with Cancer
Action CodesER, NR
Study Coordinator(s)Ravi Parikh, M.D., Manali Patel, M.D.
ParticipantsLimited: SWOG NCORP Cancer Care Delivery Research (CCDR) Components
S2433Phase III

Revision # 1 - Version Date 8/01/2026

Randomized Phase III Study of Second-Line Chemotherapy with or without Panitumumab for Locally Advanced or Metastatic KRAS Wild Type Pancreatic Adenocarcinoma
Action CodesAC, ER
Study Coordinator(s)Rachael Safyan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2505Phase III

Memorandum - S2505 October 2026 Kick Off Meeting Materials Now Available

Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB, Extremity, Resectable Soft Tissue Sarcoma
Action CodesNR
Study Coordinator(s)Jeremy Harris, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
SN2426Phase II

Memorandum - Updated Master Forms Set

A Randomized Phase II Study of Amivantamab (JNJ-61186372) and hyaluronidase (rHuPH20) versus Cetuximab in Immunocompromised Participants with Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma
Action CodesNR
Study Coordinator(s)Paul Swiecicki, M.D,
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
  • 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