Phase 3 Clinical Trials in 2025

2025 Phase 3 Research Overview

Phase 3 clinical trials started in 2025 provide a snapshot of the medical research landscape. In total, 89 such trials were initiated. 71 of these are still actively recruiting. Leading sponsors include National Cancer Institute (NCI), Bristol-Myers Squibb, Amgen.

89

Phase 3 Trials

71

Recruiting

10

Sponsors

Trial Status

RECRUITING: 71 trials
ACTIVE NOT RECRUITING: 9 trials
NOT YET RECRUITING: 7 trials
ENROLLING BY INVITATION: 1 trial
WITHDRAWN: 1 trial

Top Sponsors (2025)

National Cancer Institute (NCI) (6 trials)
Bristol-Myers Squibb (5 trials)
Amgen (5 trials)
Pfizer (4 trials)
Assistance Publique - Hôpitaux de Paris (4 trials)
Novartis Pharmaceuticals (4 trials)
Merck Sharp & Dohme LLC (4 trials)
Hoffmann-La Roche (3 trials)
AstraZeneca (3 trials)
GlaxoSmithKline (2 trials)

Phase 3 Trials Started in 2025

Epicardial Cardiac Fat Comparative Trial

NCT07297589 · RECRUITING · Phase 3 · Instituto Mexicano del Seguro Social

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

NCT06932562 · RECRUITING · Phase 3 · European Myeloma Network B.V.

A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

NCT07128199 · RECRUITING · Phase 3 · Taiho Oncology, Inc.

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 (ALPACCA)

NCT07185997 · RECRUITING · Phase 3 · ArriVent BioPharma, Inc.

A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature

NCT07221851 · RECRUITING · Phase 3 · Ascendis Pharma A/S

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

NCT07221188 · RECRUITING · Phase 3 · GlaxoSmithKline

An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder

NCT06793397 · RECRUITING · Phase 3 · Cybin IRL Limited

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

NCT07226999 · RECRUITING · Phase 3 · Pfizer

Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure

NCT07038356 · RECRUITING · Phase 3 · Christian Schulze

A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX/XELOX + Nivolumab)

NCT06346197 · RECRUITING · Phase 3 · Centre Leon Berard

Dapagliflozin for Cardio-renal Protection After ICU Discharge: A Prospective, Randomized, Double Blinded, Multicenter Study: "DAPA-ICU Trial"

NCT07025629 · RECRUITING · Phase 3 · Assistance Publique - Hôpitaux de Paris

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitean-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

NCT06524544 · RECRUITING · Phase 3 · National Cancer Institute (NCI)

A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Trial Evaluating QL1706 With Bevacizumab Versus Standard Platinum-Based Chemotherapy With or Without Bevacizumab as First-line Treatment for Advanced Ovarian Clear Cell Carcinoma

NCT07002346 · RECRUITING · Phase 3 · Tongji Hospital

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

NCT07170150 · RECRUITING · Phase 3 · Hoffmann-La Roche

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

NCT07225504 · RECRUITING · Phase 3 · Novartis Pharmaceuticals

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

NCT07100080 · RECRUITING · Phase 3 · Bristol-Myers Squibb

NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab Versus Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer

NCT07061977 · RECRUITING · Phase 3 · National Cancer Institute (NCI)

A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis

NCT07321093 · RECRUITING · Phase 3 · Biocad

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

NCT07221227 · RECRUITING · Phase 3 · GlaxoSmithKline

A Prospective, Open-Label, Randomized Controlled Study of Risankizumab (an IL-23 Inhibitor) for the Treatment of Fibrostenotic Crohn's Disease

NCT07177118 · NOT YET RECRUITING · Phase 3 · First Affiliated Hospital of Wenzhou Medical University

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

NCT07200830 · NOT YET RECRUITING · Phase 3 · Alliance for Clinical Trials in Oncology

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

NCT07190248 · RECRUITING · Phase 3 · Merck Sharp & Dohme LLC

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

NCT07106762 · RECRUITING · Phase 3 · Bristol-Myers Squibb

PADL1NK-005: 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 (NSCLC)

NCT07144280 · RECRUITING · Phase 3 · Pfizer

Efficacy, Safety, and Tolerability of a GLP-1/GCG Dual Receptor Agonist in Type 2 Diabetes With Early Dementia: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial

NCT07083154 · RECRUITING · Phase 3 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

NCT07181109 · RECRUITING · Phase 3 · Alnylam Pharmaceuticals

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis

NCT07116967 · RECRUITING · Phase 3 · Bristol-Myers Squibb

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

NCT07169578 · RECRUITING · Phase 3 · Hoffmann-La Roche

ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients With Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy With HER2 Blockade

NCT06876714 · RECRUITING · Phase 3 · Alliance for Clinical Trials in Oncology

Comparison of Esketamine Versus Aripiprazole,Both in Combination With a SSRI/SNRI(Selective Serotonin Reuptake Inhibitors/Serotonin and Norepinephrine Reuptake Inhibitors )in Treatment-resistant Major Depressive Disorder in Elderly Patients

NCT07153406 · NOT YET RECRUITING · Phase 3 · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

NCT07043725 · RECRUITING · Phase 3 · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

NCT06926868 · RECRUITING · Phase 3 · Bristol-Myers Squibb

A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

NCT07011719 · RECRUITING · Phase 3 · Arcus Biosciences, Inc.

A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis

NCT07189325 · NOT YET RECRUITING · Phase 3 · University Hospital, Montpellier

Efficacy of a Combination of Chronotherapeutics for the Treatment of Major Depressive Episode (MDE) With Insomnia: a Multicenter, Randomized, 2*2 Factorial, Double-blind, Placebo-controlled Trial

NCT07120880 · NOT YET RECRUITING · Phase 3 · Assistance Publique - Hôpitaux de Paris

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

NCT06982521 · RECRUITING · Phase 3 · Relay Therapeutics, Inc.

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

NCT07154706 · RECRUITING · Phase 3 · Nuvation Bio Inc.

A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

NCT07005128 · RECRUITING · Phase 3 · Amgen

A Randomized Phase III Trial of Checkpoint Blockade in Lung Cancer Patients in the Adjuvant Setting Based on Pathologic Response Following Neoadjuvant Therapy (CLEAR)

NCT06732401 · ACTIVE NOT RECRUITING · Phase 3 · National Cancer Institute (NCI)

An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

NCT07062965 · RECRUITING · Phase 3 · Pfizer

A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

NCT07005102 · RECRUITING · Phase 3 · AbbVie

A Prospective Multicenter RCT Study of Deep Jugular Lymphovenous Anastomosis in the Treatment of Alzheimer's Disease

NCT07060391 · NOT YET RECRUITING · Phase 3 · Shanghai Jiao Tong University School of Medicine

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

NCT07037433 · RECRUITING · Phase 3 · Amgen

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

NCT06846281 · RECRUITING · Phase 3 · Novartis Pharmaceuticals

AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)

NCT06758401 · RECRUITING · Phase 3 · Pfizer

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

NCT07060807 · RECRUITING · Phase 3 · Merck Sharp & Dohme LLC

A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)

NCT06605105 · ENROLLING BY INVITATION · Phase 3 · Cybin IRL Limited

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis

NCT07211633 · RECRUITING · Phase 3 · TG Therapeutics, Inc.

A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy

NCT06928389 · RECRUITING · Phase 3 · Akeso

TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

NCT07052903 · RECRUITING · Phase 3 · Alnylam Pharmaceuticals

A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer

NCT06855277 · RECRUITING · Phase 3 · Novartis Pharmaceuticals

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

NCT06966700 · RECRUITING · Phase 3 · Merck Sharp & Dohme LLC

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

NCT07037459 · RECRUITING · Phase 3 · Amgen

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants With Type 2 Diabetes Who Are Obese, or Overweight

NCT07104383 · ACTIVE NOT RECRUITING · Phase 3 · Viking Therapeutics, Inc.

A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days (MMDs) Over 12 Weeks of Treatment With CGRP mAbs and Onabotulinumtoxin A Intramuscularly Compared With CGRP mAbs and Placebo in Chronic Migraine

NCT07040813 · RECRUITING · Phase 3 · Oslo University Hospital

Salvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With Polyangiitis

NCT04871191 · RECRUITING · Phase 3 · Assistance Publique - Hôpitaux de Paris

A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma

NCT06790966 · ACTIVE NOT RECRUITING · Phase 3 · PDS Biotechnology Corp.

EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) < 40%

NCT06935370 · RECRUITING · Phase 3 · Boehringer Ingelheim

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)

NCT06563895 · RECRUITING · Phase 3 · Eidos Therapeutics, a BridgeBio company

EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease

NCT07064473 · RECRUITING · Phase 3 · Boehringer Ingelheim

A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia

NCT06860269 · RECRUITING · Phase 3 · Assistance Publique - Hôpitaux de Paris

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight

NCT06914895 · ACTIVE NOT RECRUITING · Phase 3 · Eli Lilly and Company

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)

NCT06875310 · RECRUITING · Phase 3 · Mirati Therapeutics Inc.

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Emerge

NCT06941844 · ACTIVE NOT RECRUITING · Phase 3 · Definium Therapeutics US, Inc.

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

NCT06790693 · RECRUITING · Phase 3 · Hoffmann-La Roche

Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)

NCT06498635 · RECRUITING · Phase 3 · National Cancer Institute (NCI)

A Multicenter Randomized, Double-blinded, Parallel, Positive-controlled, Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of QL2108 to Dupixent® in Adult Subjects With Moderate-to-Severe Atopic Dermatitis.

NCT06884891 · NOT YET RECRUITING · Phase 3 · Qilu Pharmaceutical Co., Ltd.

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

NCT06589804 · RECRUITING · Phase 3 · National Cancer Institute (NCI)

Effect of Semaglutide in Patients With Psoriasis and Obesity

NCT06937060 · RECRUITING · Phase 3 · The University of Hong Kong

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

NCT06841354 · RECRUITING · Phase 3 · Merck Sharp & Dohme LLC

A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death

NCT06677060 · RECRUITING · Phase 3 · AstraZeneca

An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis

NCT06869785 · ACTIVE NOT RECRUITING · Phase 3 · Novartis Pharmaceuticals

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (Radiate-LM)

NCT06500481 · RECRUITING · Phase 3 · NRG Oncology

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

NCT06742723 · RECRUITING · Phase 3 · AstraZeneca

Simplification of Treatment by Withdrawal of Medications in Stable Heart Failure With Improved Left Ventricular Ejection Fraction

NCT07489547 · RECRUITING · Phase 3 · Hospital de Clinicas de Porto Alegre

Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery

NCT06810375 · RECRUITING · Phase 3 · George Washington University

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis (MASH) and F2/F3 Fibrosis (FASCINATE-3)

NCT06594523 · WITHDRAWN · Phase 3 · Sagimet Biosciences Inc.

Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial

NCT06840704 · RECRUITING · Phase 3 · Hunan Cancer Hospital

A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)

NCT06747949 · RECRUITING · Phase 3 · Amgen

A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

NCT06646276 · RECRUITING · Phase 3 · Bristol-Myers Squibb

A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT06838273 · RECRUITING · Phase 3 · Sichuan Baili Pharmaceutical Co., Ltd.

Randomized Phase III Trial of Neoadjuvant Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (C-PRE)

NCT06568172 · RECRUITING · Phase 3 · National Cancer Institute (NCI)

A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN

NCT06431633 · RECRUITING · Phase 3 · Fundación GECP

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40 Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Panorama

NCT06809595 · ACTIVE NOT RECRUITING · Phase 3 · Definium Therapeutics US, Inc.

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT06788990 · RECRUITING · Phase 3 · Bicara Therapeutics

HAELO: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants With Hereditary Angioedema (HAE)

NCT06634420 · ACTIVE NOT RECRUITING · Phase 3 · Intellia Therapeutics

An International, Multicentre, Open-label Randomised Phase III Trial to Evaluate the Benefit of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy Plus Durvalumab in Patients With Stage IIB-IIIB (N2) Resectable NSCLC

NCT06284317 · RECRUITING · Phase 3 · ETOP IBCSG Partners Foundation

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

NCT06700343 · RECRUITING · Phase 3 · Amgen

A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With HR+ / HER2- Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain

NCT06764186 · ACTIVE NOT RECRUITING · Phase 3 · AstraZeneca

Frequently Asked Questions

How many Phase 3 trials started in 2025?

89 Phase 3 clinical trials were started in 2025 according to ClinicalTrials.gov data tracked by ReadTheTrial.

What is Phase 3 in clinical trials?

Phase 3 trials are large-scale pivotal studies with 300-3,000+ participants for FDA approval.

Are any 2025 Phase 3 trials recruiting?

Yes, 71 Phase 3 trials from 2025 are still recruiting.

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