14 completed, 10 recruiting, 4 active not recruiting. 28 Phase 3, 8 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 28 | Completed 14, Recruiting 10, Active not recruiting 4 |
| Phase 2 | 8 | Completed 4, Recruiting 3, Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of COVID-19 Vaccine(s) in Children and Adults BNT162b2 - COVID-19 Vaccines | Phase 3 | Recruiting | BioNTech SE | 700 | 2026-08-31 | 2026-09-28 |
| A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer BNT324, Docetaxel, Prednisone/prednisolone - Metastatic Castration-resistant Prostate Cancer | Phase 3 | Recruiting | BioNTech SE | 736 | 2026-04-22 | 2026-10-16 |
| A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) Pumitamig, Durvalumab - Non-small Cell Lung Cancer (NSCLC) | Phase 3 | Recruiting | Bristol-Myers Squibb | 850 | 2026-03-16 | 2026-11-05 |
| A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) Pumitamig, Folfox, Capox - Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma | Phase 2 / Phase 3 | Recruiting | Bristol-Myers Squibb | 690 | 2026-03-13 | 2026-11-05 |
| A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) Pumitamig, Pembrolizumab - Non-Small Cell Lung Cancer (NSCLC) | Phase 3 | Recruiting | Bristol-Myers Squibb | 750 | 2026-03-12 | 2026-10-23 |
| A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer Pumitamig, FOLFOX, FOLFIRI - Untreated, Unresectable, or Metastatic Colorectal Cancer | Phase 2 / Phase 3 | Recruiting | Bristol-Myers Squibb | 990 | 2025-12-31 | 2026-10-23 |
| A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age BNT162b2 Vaccine, Placebo - COVID-19, SARS-COV-2 Infection | Phase 3 | Completed | BioNTech SE | 5240 | 2025-12-10 | 2026-10-16 |
| A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19 BNT162b2 (2025/2026 formulation) - COVID-19, SARS-COV-2 Infection | Phase 3 | Completed | BioNTech SE | 344 | 2025-10-30 | 2026-08-07 |
| ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine - Breast Neoplasms | Phase 3 | Recruiting | BioNTech SE | 558 | 2025-10-30 | 2026-10-30 |
| A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) - COVID-19, SARS-COV-2 Infection | Phase 3 | Completed | BioNTech SE | 774 | 2025-07-08 | 2026-06-01 |
| A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer BNT323/DB-1303, Doxorubicin, Paclitaxel - Endometrial Cancer | Phase 3 | Recruiting | BioNTech SE | 480 | 2025-06-10 | 2026-10-16 |
| Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer Pumitamig, Atezolizumab, Etoposide - Extensive-stage Small-cell Lung Cancer | Phase 3 | Recruiting | BioNTech SE | 621 | 2025-02-03 | 2026-10-14 |
| Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02) Pumitamig, Pembrolizumab, Carboplatin - Non-small Cell Lung Cancer | Phase 2 / Phase 3 | Recruiting | BioNTech SE | 1580 | 2025-01-07 | 2026-11-02 |
| A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer DB-1303/BNT323, T-DM1 - HER2-positive Breast Cancer | Phase 3 | Active not recruiting | DualityBio Inc. | 228 | 2024-01-29 | 2026-10-30 |
| A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) DB-1303/BNT323, Capecitabine, Paclitaxel - Metastatic Breast Cancer | Phase 3 | Active not recruiting | DualityBio Inc. | 541 | 2024-01-18 | 2026-09-24 |
| A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza. Influenza and COVID-19 Combination A, Licensed influenza vaccine, COVID-19 Vaccine - Influenza, COVID-19 | Phase 3 | Completed | BioNTech SE | 8795 | 2023-12-20 | 2025-12-04 |
| A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2) - SARS-CoV-2 Infection, COVID-19 | Phase 2 / Phase 3 | Completed | BioNTech SE | 1051 | 2023-08-10 | 2026-04-28 |
| ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors Gotistobart, Docetaxel - Non Small Cell Lung Cancer | Phase 3 | Active not recruiting | OncoC4, Inc. | 630 | 2023-06-28 | 2026-08-13 |
| A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose - SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2 | Phase 3 | Completed | BioNTech SE | 4338 | 2022-09-23 | 2026-08-06 |
| A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals BNT162b5 Bivalent (WT/OMI BA.2), BNT162b2 Bivalent (WT/OMI BA.1), BNT162b2 Bivalent (WT/OMI BA.4/BA.5) - SARS-CoV-2 Infection, COVID-19 | Phase 2 / Phase 3 | Completed | BioNTech SE | 1453 | 2022-07-26 | 2025-10-01 |
Showing 20 of 28. Sign in to see all of them.
COVID-19 (15) · Coronavirus Infections (9) · Carcinoma, Non-Small-Cell Lung (4) · Breast Neoplasms (3) · Coronaviridae Infections (2) · Infections (2) · Lung Diseases (2) · Lung Neoplasms (2) · Respiratory Tract Diseases (2) · Respiratory Tract Infections (2) · Virus Diseases (2) · Adenocarcinoma Of Esophagus (1) · Colorectal Neoplasms (1) · Endometrial Neoplasms (1) · Head and Neck Neoplasms (1)
BNT162 Vaccine (12) · Carboplatin (3) · Docetaxel (3) · Paclitaxel (3) · pembrolizumab (3) · 130-nm albumin-bound paclitaxel (2) · Folfox protocol (2) · Bevacizumab (1) · Biological Products (1) · COVID-19 Vaccines (1) · Capecitabine (1) · Doxorubicin (1) · Etoposide (1) · Gemcitabine (1) · IFL protocol (1)
United States (26) · Germany (14) · Australia (13) · Brazil (13) · Spain (13) · United Kingdom (13) · China (12) · Poland (12) · Italy (11) · South Korea (11) · Argentina (10) · Belgium (10) · Turkey (Türkiye) (10) · Canada (9) · France (9)
Joyce O'Shaughnessy, PHD (1) · Kai He, MD, PhD (1) · Lily Hu (1) · Mark Socinski, MD (1) · Tianhong Li, MD, PhD (1)
PMID 38400102, PMID 39066372, PMID 39197299, PMID 32785213, PMID 33053279, PMID 33301246, PMID 33524990, PMID 34043894, PMID 34525277, PMID 34752019, PMID 35131133, PMID 35316227, PMID 35320659, PMID 35472295, PMID 35473709, PMID 35739094, PMID 35792746, PMID 36055877, PMID 36652353, PMID 36791162, PMID 36929216, PMID 37527039, PMID 37698774, PMID 38012751, PMID 38016021, PMID 39999538, PMID 40237463, PMID 40396505, PMID 40591130, PMID 40966692, PMID 41560517, PMID 41896648, PMID 42042826, PMID 42501282, PMID 42646694
2025 (5), 2023 (3)