Clinical Trials

Information on ongoing or completed clinical trials can be found at the NCI Clinical Trials website. For additional information regarding PrECOG clinical trials please contact PrECOG.

Collaboration with PrECOG

PrECOG collaborates with research groups and industry partners to explore innovative collaborations to achieve combined research interests. These research relationships offer different levels of partnership and are designed to facilitate research results. In these models, we align support of the study to achieve mutual developmental needs [e.g. data contributing to a potential regulatory filing or data request, publication, etc.]. To inquire further about research collaborations, please contact PrECOG.

Featured Trial

PrE1702 – Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients Not Enrolled in Clinical Trials

This study is testing the feasibility of using real-world data collection—through the recruitment of well-characterized patients into a registry—to compare outcomes from osimertinib-based treatments. PrE1702 aims to obtain data on patients treated in routine clinical practice (outside of a clinical trial) with standard-of-care osimertinib with or without chemotherapy. The goal is to better understand the impact of these regimens. Learn more in this blog post and contact PrECOG if your site is interested in participating.

Study IDTumorStudy StatusStudy TitleNCT ID
PrE0102BreastCompletedRandomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) Plus Everolimus in Post-Menopausal Patients With Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy https://clinicaltrials.gov/ct2/show/NCT01797120 NCT01797120
PrE0105 BreastCompletedA Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer https://clinicaltrials.gov/ct2/show/NCT00813956 NCT00813956
PrE0109 AFT-05BreastActive, Not RecruitingAFT-05: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer https://clinicaltrials.gov/ct2/show/NCT02513394 NCT02513394
PrE0111 AFT-38BreastActive, Not RecruitingAFT-38: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer https://clinicaltrials.gov/ct2/show/NCT02947685 NCT02947685
PrE0113BreastActive, Not RecruitingA Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study https://clinicaltrials.gov/ct2/show/NCT04215146 NCT04215146
PrE0204GICompletedA Multi-institutional, Single arm, Two-stage Phase II Trial of Nab-paclitaxel and Gemcitabine for First-line Treatment of Patients with Advanced or Metastatic Cholangiocarcinoma https://clinicaltrials.gov/ct2/show/NCT02181634 NCT02181634
PrE0401LymphomaCompletedPhase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma https://clinicaltrials.gov/ct2/show/NCT01889797 NCT01889797
PrE0403LymphomaCompletedPhase II Study of Venetoclax (ABT-199/GDC-0199) in Combination With Obinutuzumab and Bendamustine in Patients With High Tumor Burden Follicular Lymphoma as Front Line Therapy https://clinicaltrials.gov/ct2/show/NCT03113422 NCT03113422
PrE0404LymphomaActive, Not RecruitingA Phase I/II Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma https://clinicaltrials.gov/ct2/show/NCT03323151 NCT03323151
PrE0405LymphomaActive, Not RecruitingPhase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age https://clinicaltrials.gov/ct2/show/NCT03834688 NCT03834688
PrE0501ThoracicCompletedA Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination With Docetaxel and Carboplatin Followed by Placebo or Maintenance Therapy With Vandetanib in Patients With IIIb, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) https://clinicaltrials.gov/ct2/show/NCT00687297 NCT00687297
PrE0502ThoracicCompletedAn Open-Label, Randomized, Phase IIIb Trial Evaluating The Efficacy And Safety Of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression Of Disease In Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After First-Line Treatment With Bevacizumab Plus A Platinum Doublet-Containing Chemotherapy (MO22097) https://clinicaltrials.gov/ct2/show/NCT01351415 NCT01351415
PrE0504ThoracicCompletedA Phase I/II Study of Glembatumumab Vedotin in Patients With gpNMB-Expressing, Advanced or Metastatic Squamous Cell Carcinoma of the Lung https://clinicaltrials.gov/ct2/show/NCT02713828 NCT02713828
PrE0505ThoracicCompletedAnti - Programmed Death – Ligand 1 Antibody, Durvalumab, in Combination with Chemotherapy for the First-Line Treatment of Unresectable Mesothelioma https://clinicaltrials.gov/ct2/show/NCT02899195 NCT02899195
PrE0506ThoracicActive, Not RecruitingDuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma (DREAM3R) https://clinicaltrials.gov/ct2/show/NCT04334759 NCT04334759
PrE0801GUCompletedNEXT: Subsequent exposure to tyrosine kinase inhibition (TKI) at recurrence after adjuvant therapy in renal cell carcinoma (RCC) https://clinicaltrials.gov/ct2/show/NCT01649180 NCT01649180
PrE0807GUCompletedPhase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer https://clinicaltrials.gov/ct2/show/NCT03532451 NCT03532451
PrE0901LeukemiaCompletedPhase I Dose Finding/Phase II Placebo-Controlled Trial of Eltrombopag During Consolidation Therapy in Adults With Acute Myeloid Leukemia (AML) in Complete Remission https://clinicaltrials.gov/ct2/show/NCT01656252 NCT01656252
PrE0905LeukemiaActive, Not RecruitingRandomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia https://clinicaltrials.gov/ct2/show/NCT03836209 NCT03836209
PrE1003Multiple MyelomaCompletedA Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function https://clinicaltrials.gov/ct2/show/NCT00790842 NCT00790842
PrE1702ThoracicActive, RecruitingReal World Data: Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients https://clinicaltrials.gov/study/NCT06538038 NCT06538038

Submit a Study Idea

Ideas for trials can be submitted to PrECOG for consideration by ECOG-ACRIN Cancer Research Group members in good standing, or other collaborators after discussions with PrECOG. Research ideas are developed and submitted to PrECOG by investigators as detailed study concepts. Once reviewed and approved, PrECOG will work to operationalize study concepts. The process for reviews is streamlined by parallel scientific [PrECOG/ECOG-ACRIN Cancer Research Group] and industry partner reviews. NCI review and approval is not required. Please contact PrECOG, to discuss any trial ideas.

Participate in PrECOG Trials

Sites are selected to participate in PrECOG trials based on current research standing, prior study performance, experience, and study feasibility. Potential sites provide information for specific study requirements under confidentiality including projected enrollment, research facility information, etc. Site selection follows all applicable regulations required by sponsors and researchers. Sites are notified of selection to participate after this process is complete. To ask about your site participating in PrECOG trials, please contact PrECOG.