CLINICAL TRIALS
CLINICAL TRIALS
Our partnership with OneOncology provides us access to the OneOncology Research Network (OneR), a national site management organization that brings operational expertise and centralized services to efficiently deliver multi-center clinical research across our growing network of oncology practices.
Since clinical trials are increasingly integral to the standard of care for precision oncology, the OneR platform expands patients’ access to more innovative therapies. At the same time, OneR provides clinical trial sponsors access to the large and diverse populations of patients who are treated in community centers throughout their cancer journey, and not episodic as is more common in research-based academic centers. With a majority of cancer care being delivered in community-based centers, OneR ensures diversity in clinical trial participation including ethnicity, gender, geography, disease status, socioeconomics and various other dimensions.
Breast Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| LAHOMG | NCT05296798 | Breast ER+ / HER2+ | WO43571 | 3 | (heredERA) A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer | Seneviratne | Breast Cancer |
| LAHOMG CCCMG | NCT05952557 | Breast ER+ / HER2- | D8535C00001 | 3 | (CAMBRIA-2) A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease | Seneviratne | Breast Cancer |
| LAHOMG | NCT05840211 | Breast ER+ / HER2- | GS-US-598-6168 | 3 | (ASCENT-07) A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy | Seneviratne | Breast Cancer |
| CCCMG PCMC RVSD | NCT05774951 | Breast ER+ / HER2- | D8531C00002 | 3 | (CAMBRIA-1) A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer | Maniam | Breast Cancer |
| LAHOMG PCMC | NCT05306340 | Breast ER+ / HER2- | ML43171 | 3 | A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer | Charu | Breast Cancer |
| PCMC | NCT05501886 | Breast ER+ / HER2- | CELC-G-301 | 3 | (VIKTORIA-1) Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy | Charu | Breast Cancer |
| LAHOMG | NCT05646862 | Breast ER+ / HER2- PIK3CA mut | WO43919 | 3 | (INAVO121) A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy | Seneviratne | Breast Cancer |
| CCCMG | NCT05894239 | Breast HER2+ PIK3CA mut | WO44263 | 3 | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | Breast Cancer | |
| LAHOMG | NCT0534512 | Breast TN | D926PC00001 | 3 | (TROPION-Breast02) A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer | Seneviratne | Breast Cancer |
| LAHOMG CCMG | NCT05633654 | Breast TN | GS-US-595-6184 | 3 | (ASCENT-05) A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy | Seneviratne | Breast Cancer |
| LAHOMG | NCT05629585 | Breast TN | D926XC00001 | 3 | (TROPION-Breast03) A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy | Seneviratne | Breast Cancer |
| LAHOMG CCMG | NCT06103864 | Breast TN | D7630C00001 | 3 | (TROPION-Breast05) A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer | Breast Cancer |
Lymphoma Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| PCMC | NCT05254743 | CLL | BRUIN-CLL-314 | 3 | (BRUIN-CLL-314) A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Charu | Lymphoma |
| CCCMG | NCT05451810 | R/R DLBCL R/R FL | M23-362 | 2 | A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting | Lymphoma | |
| LAHOMG CCCMG | NCT05100862 | R/R FL R/R MZL | BGB-3111-308 | 3 | (MAHOGANY) A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma | Seneviratne | Lymphoma |
Lung Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| LAHOMG | GlaxoSmithKline | NCT05565378 | 213824 | 2 | (GALAXIES LUNG-201) A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer | Seneviratne | Lung Cancer |
| LAHOMG | NCT05687266 | NSCLC | D926NC00001 | 3 | (AVANZAR) A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations | Seneviratne | Lung Cancer |
| CCCMG | NCT05456256 | NSCLC | LTRN300-2LC01-OR21 | 2 | (HARMONIC) Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors | Lee | Lung Cancer |
| PCMC | NCT04036682 | NSCLC | CLN-081-001 | 1/2 | A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy | Charu | Lung Cancer |
| LAHOMG CCCMG | NCT06159790 | NSCLC | CGME751A12301 | 3 | A Randomized, Double-blind, Parallel-group Study to Compare Efficacy, Safety, and Immunogenicity of GME751 (Proposed Pembrolizumab Biosimilar) and EU-authorized Keytruda® in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) | Lung Cancer | |
| RVSD CORONA | NCT05555732 | NSCLC PD-L1 <50% | DS1062-A-U303 | 3 | (TROPION-Lung07) Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations | Choi | Lung Cancer |
| RVSD CORONA | NCT05215340 | NSCLC PD-L1 ≥50% | DS1062-A-U304 | 3 | (TROPION-Lung08) Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations | Choi | Lung Cancer |
| LAHOMG CCCMG | NCT04063163 | SCLC Extensive Stage | HLX10-005-SCLC301 | 3 | (ASTRIDE) A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Clinical Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) | Kyung | Lung Cancer |
| LAHOMG | NCT06095583 | SCLC Extensive Stage | JS004-008-III-SCLC | 3 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy | Lung Cancer |
Gastric Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| LAHOMG | NCT05702229 | Gastric GEJ | D7986C00001 | 2 | (GEMINI) An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma | Kyung | Gastric Cancer |
Hemolytic Anemia Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| RVSD CORONA | NCT04119050 | Hemolytic Anemia | CR108987 | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension | Choi | Hemolytic Anemia |
Immune Thrombocytopenia/ Thrombocytopenia Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| CCCMG | NCT05653349 | ITP | CVAY736I12301 | 3 | (VAYHIT1) A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia | Lee | Immune Thrombocytopenia |
| CCCMG | NCT05653219 | ITP | CVAY736Q12301 | 3 | (VAYHIT2) A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment | Lee | Immune Thrombocytopenia |
| PCMC | NCT03362177 | Thrombocytopenia | 20140346 | 3 | (RECITE) A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer | Maniam | Thrombocytopenia |
Colorectal Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| PCMC LAHOMG | NCT06106308 | mCRC RAS mut | CRDF-004 | 2 | A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation | Charu | Colorectal Cancer |
| LAHOMG PCMC | NCT05253651 | mCRC RAS wt | SGNTUC-029 | 3 | (MOUNTAINEER-03) An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer | Kyung | Colorectal Cancer |
Multiple Myeloma Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| CCCMG | NCT05827016 | MM | IM048-022 | 3 | (EXCALIBER-Maint) A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) | Pan | Multiple Myeloma |
| LAHOMG | NCT05552976 | R/R MM | CA057-008 | 3 | (SUCCESSOR-2) A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) | Seneviratne | Multiple Myeloma |
Prostate Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| PCMC | NCT03460977 | Prostate | C2321001 | 1 | A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL) | Maniam | Prostate Cancer |
Urothelial Cancer Trials
| LOCATION | CT.GOV | INDICATION | PROTOCOL # | PHASE | TITLE | PI | TUMOR |
|---|---|---|---|---|---|---|---|
| CCCMG | NCT05911295 | Urothelial | SGNDV-001 | 3 | An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater) | Urothelial |
