Available Trials

---

• Bladder
• Breast
• Colorectal
• Colorectal/GI/Gastrointestinal
• Endometrial
• Gastric
• Gastric/Gastroesophageal
• Gynecological/Ovarian
• Head/Neck
• Hematology
• Leukemia
• Lung - Non-Small Cell Lung
• Lung - Small Cell Lung
• Lymphoma
• Prostate
• Solid Tumor
• STAR: Selected Trials Available for Accelerated Four Week Rollout

---

Bladder

• USOR 25235- Ph3 Study of Enfortumab Vedotin + Pembro in Muscle Invasive Bladder Cancer

  A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY
  

  Available at Chicago, Niles, Arlington Heights

---

Breast

• USOR 23309 - Ph3 Study of Post-Neoadjuvant MK2870 in combo with Pembro (MK3475) with triple neg breast cancer

  A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) At Surgery
  

  Available at Arlington Heights, Chicago, Niles

---

Colorectal

• 25219 - Ph3 precemtabart tocentecan +/- bevacizumab vs trifluridine/tipiracil + bevacizumab in CRC

  A randomized, open-label, 3-arm Phase 3 study of precemtabart tocentecan with or without bevacizumab compared to trifluridine/tipiracil plus bevacizumab in participants with previously treated metastatic colorectal cancer (PROCEADE-CRC-03)
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25156 - ACCELERO: Ph3 PF-08634404 + Chemo vs Pembro + Chemo in Locally Advanced or Metastatic NSCLC

  AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25065 - STAR Beamion LUNG3 study of zongertinib with patients with NSCLC

  A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25187 - Ph1/1b Evaluating Targeted Therapies in Subpopulations of Patients with Met CRC (INTRINSIC)

  A PHASE I/Ib GLOBAL, MULTICENTER, OPEN-LABEL UMBRELLA STUDY EVALUATING THE SAFETY AND EFFICACY OF TARGETED THERAPIES IN SUBPOPULATIONS OF PATIENTS WITH METASTATIC COLORECTAL CANCER (INTRINSIC)
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25157 - ACCELERO: Ph3 PF-08634404 (SSGJ707) in Combo With Chemo vs Bevacizumab With Chemo for Metastatic CRC

  AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24246 - Ph2 Study of Fruquintinib plus FOLFIRI as 2L Treatment for mCRC

  A Phase II Study Investigating Fruquintinib plus FOLFIRI as Second-Line Treatment for Participants with Metastatic Colorectal Cancer (FRUITFUL)
  

  Available at Arlington Heights, Niles, Chicago

• USOR 24155 - Ph3 study of mFOLFOX6 as FIL treatment in subjects with colorectal cancer

  A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
  

  Available at Arlington Heights, Chicago, Niles

• USOR 2409824098 - Ph3 study of FOLFIRI in participants with metastatic colorectal cancer

  A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants with KRAS/NRAS and BFAF Wild-Type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
  

  Available at Arlington Heights, Chicago, Niles

---

Colorectal/GI/Gastrointestinal

• USOR 24093 - Ph3 study of T-DXd vs SOC gemcitabine for HER2-expressing Biliary Tract Cancer

  DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer (D781PC00001)
  

  Available at Arlington Heights, Chicago, Niles

---

Endometrial

• USOR 24046 - Ph3 study of T-DXd in patients with HER2-expressing endometrial cancer

  An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as FirstLine Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer
  

  Available at Arlington Heights, Chicago, Niles

---

Gastric

• USOR 25120 - Ph3 Sonesitatug vedotin + Fluoropyrimidine in Gastric, GEJ, or Esophageal Adeno (CLARITY-Gastric02)

  A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2 negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24152 - Ph3 study of ARTEMIDE-GASTRIC01 in combo with pembro FIL gastric cancer

  A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer.
  

  Available at Arlington Heights, Chicago, Niles

---

Gastric/Gastroesophageal

• USOR 25227 - Ph2/3 study of PF-08634404 in combination w/ chemo in adults w/ LA/m Gastroesophageal Cancers

  A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25120 - Ph3 Sonesitatug vedotin + Fluoropyrimidine in Gastric, GEJ, or Esophageal Adeno (CLARITY-Gastric02)

  A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2 negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
  

  Available at Arlington Heights, Chicago, Niles

---

Gynecological/Ovarian

• USOR 25137 - Ph3 of LY4170156 vs Chemo or Mirvetuximab Soravtansine in Ovarian (FRAmework-01)

  A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24186- Ph3 multicenter study of MK2870 in subjects with ovarian cancer (GOG-3102)

  A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy
  

  Available at Arlington Heights, Chicago, Niles

---

Head/Neck

• USOR 23234 - Ph3 Study of Volrustomig (MEDI5752) Advanced-HNSCC LA-HNSCC (eVOLVE-HNSCC)

  A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced-Head and Neck Squamous Cell Carcinoma (LA-HNSCC) Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC), D798EC00001
  

  Available at Arlington Heights, Niles

---

Hematology

• USOR 24221 - STAR Ph3 study of mavorixafor in sbjcts with neutropenic disorders w/ recurrent serious infections

  A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of mavorixafor in participants with congenital and acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infection
  

  Available at Arlington Heights, Niles, Chicago

---

Leukemia

• USOR 24198 - Ph3 study of Bleximenib, Venetoclax & Azacitidine in participants with AML

  A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2ARearrangements or NPM1Mutations who are Ineligible for Intensive Chemotherapy
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24266 - Ph3 Study of Sonrotoclax plus Anti-CD20 in patients with chronic/small Lymphocytic Leukemia/Lymph

  A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  

  Available at Arlington Heights, Niles

---

Lung - Non-Small Cell Lung

• USOR 24232 - STAR Ph3 Study of NVL-655 Compared to Alectinib in First Line Tx with ALK+ NSCLC (ALKAZAR)

  A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24215 - Ph2 Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens

  A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24195- Ph3 Double blind Adagrasib+Pembro+Chemo vs Placebo+Pembro+Chemo Untreated NSCLC (KRYSTAL-4)

  A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25091 - ACCELERO: Ph3 Study to evaluate PF-08046054 vs Docetaxel in PD-L1+ NSCLC

  A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDL1V VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) POSITIVE NON-SMALL-CELL LUNG CANCER
  

  Available at Arlington Heights, Chicago, Niles

• USOR 22118 - Ph3 Soto/Doublet vs Pembro/Doublet NSCLC PD-L1 neg KRAS PG12C+ (CodeBreaK 202)

  A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202) (20190341)
  

  Available at Arlington Heights, Niles

---

Lung - Small Cell Lung

• USOR 24188 - Ph3 multisite randomized trial of BNT327 in combo with participants with SCLC

  A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer
  

  Available at Arlington Heights, Chicago, Niles

• USOR 23243 - Ph2 Randomized dose-optimization study of alisertib in patients with SCLC (PB-8237)

  A PHASE 2 STUDY OF ALISERTIB IN PATIENTS WITH EXTENSIVE SMALL CELL LUNG CANCER (PUMA-ALI-4201)
  

  Available at Arlington Heights, Niles

---

Lymphoma

• USOR 24321 - Ph3 study to compare the combo in Golca+R with follicular lymphoma

  A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination with Rituximab (Golca + R) Vs Investigator’s Choice in Participants with Relapsed/Refractory Follicular Lymphoma
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24266 - Ph3 Study of Sonrotoclax plus Anti-CD20 in patients with chronic/small Lymphocytic Leukemia/Lymph

  A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  

  Available at Arlington Heights, Niles

---

Prostate

• USOR 25230 - Ph3 trial of BNT324 versus docetaxel in metastatic castration-resistant prostate cancer

  A Phase III, randomized, open-label trial of BNT324 versus docetaxel with prednisone/prednisolone in metastatic castration-resistant prostate cancer
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24310 - Ph1/1b single agent in combo with an androgen receptor in patients with prostate

  An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination with an Androgen Receptor Pathway Inhibitor in Patients with Metastatic Prostate Cancer
  

  Available at Arlington Heights, Chicago, Niles

---

Solid Tumor

• USOR 23253 - STAR Clinical Study to Further Evaluate Trametinib with rare BRAF V600E or met Solid Tumors

  Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors (CDRB436IIC01)
  

  Available at Arlington Heights, Chicago, Niles

• USOR 23328 - STAR Ph2 study of BI 1810631 for the treatment of HER-2 mutated solid tumors

  Beamion PANTUMOR-1: A Phase II, multicentre, multicohort, open-label trial to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumours (1479-0009)
  

  Available at Arlington Heights, Niles

• USOR 22037 - STAR Ph1/2 PC14586 TP53 Y220C mut Solid Tumors (PYNNACLE)

  A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) (PMV-586-101)
  

  Available at Arlington Heights, Niles

---

STAR: Selected Trials Available for Accelerated Four Week Rollout

• USOR 24232 - STAR Ph3 Study of NVL-655 Compared to Alectinib in First Line Tx with ALK+ NSCLC (ALKAZAR)

  A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25065 - STAR Beamion LUNG3 study of zongertinib with patients with NSCLC

  A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24305 - STAR: Ph3 study to evaluate the efficacy of firmonertinib with FIL treatment in patients with NSCLC

  A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared with Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations
  

  Available at Arlington Heights, Chicago, Niles

• USOR 24320 - STAR: Ph3 multicenter study of taletrectinib in patients with ROS1-FUSION with NSCLC

  A PHASE 3 MULTICENTER DOUBLE-BLIND RANDOMIZED STUDY OF TALETRECTINIB VERSUS PLACEBO IN PATIENTS WITH ROS1-FUSION POSITIVE STAGE IB-IIIA NON-SMALL CELL LUNG CANCER WHO HAVE UNDERGONE COMPLETE TUMOR RESECTION
  

  Available at Arlington Heights, Chicago, Niles

• USOR 25010 - STAR Ph4 study of Ocular in patients with Tivdak in cervical cancer (GOG-3116)

  A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak in Recurrent or Metastatic Cervical Cancer
  

  Available at Arlington Heights, Chicago, Niles

• USOR 23251 - STAR Ph3 AZD5305 with HR+ HER2 negative advanced breast cancer (EvoPAR-Breast01)

  A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant versus Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer
  

  Available at Arlington Heights, Chicago, Niles

• USOR 23253 - STAR Clinical Study to Further Evaluate Trametinib with rare BRAF V600E or met Solid Tumors

  Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors (CDRB436IIC01)
  

  Available at Arlington Heights, Chicago, Niles

• USOR 22037 - STAR Ph1/2 PC14586 TP53 Y220C mut Solid Tumors (PYNNACLE)

  A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) (PMV-586-101)
  

  Available at Arlington Heights, Niles