Actively Recruiting
Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
Led by BioNTech SE · Updated on 2026-04-24
60
Participants Needed
30
Research Sites
186 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care. Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.
CONDITIONS
Official Title
Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed Stage IV NSCLC with progression after one prior systemic treatment line including PD-1/PD-L1 inhibitor and platinum-based chemotherapy
- Received at least two cycles of immunotherapy as first-line treatment
- Only one prior line of immunotherapy allowed in advanced/metastatic setting; disease-free interval of at least 6 months if prior adjuvant immunotherapy
- Available historical PD-L1 test results
- Participants with actionable genetic alterations allowed if treated with approved targeted agent plus immunotherapy
- Enrollment of participants with primary resistance to prior immunochemotherapy kept below 30%
- At least one measurable tumor lesion per RECIST v1.1
- Provided tumor tissue samples obtained within 18 months prior to enrollment; additional fresh biopsies required for Part 2 cohort
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ function as defined in protocol
You will not qualify if you...
- Known or suspected hypersensitivity to study treatments, their metabolites, or excipients including polysorbate 80
- Prior treatment with anti-VEGF monoclonal antibody, anti-PD-(L)-1/aVEGF bispecific antibody, or docetaxel as monotherapy or combination
- More than one prior therapy line in advanced/metastatic setting
- Systemic corticosteroids >10 mg/day prednisone (or equivalent) within 7 days before study treatment (except docetaxel premedication); local or short-term corticosteroids allowed
- Acute toxicity from prior radiotherapy
- Uncontrolled hypertension or poorly controlled diabetes within 7 days before first study dose
- Serious or non-healing wounds, incompletely healed fractures, or history/risk of fistula, gastrointestinal perforation, abscess, varices, or bleeding
- Significant risk of hemorrhage as defined by protocol
- Presence of superior vena cava syndrome or spinal cord compression symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
The University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Baptist Health Hardin
Elizabethtown, Kentucky, United States, 42701
Actively Recruiting
4
NYU Langone - NYU Grossman School of Medicine
New York, New York, United States, 10016
Actively Recruiting
5
Texas Oncology, P.A.
Houston, Texas, United States, 77090
Completed
6
Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
7
Metro South Health - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
8
Cancer Research SA (CRSA)
Adelaide, South Austraila, Australia, 5000
Actively Recruiting
9
Hobart Hospital-Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Actively Recruiting
10
One Clinical Research - Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
11
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, South Korea, 52727
Actively Recruiting
12
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
13
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
14
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
15
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
16
Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)
Barcelona, Spain, 08908
Actively Recruiting
17
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
18
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
19
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
20
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain, 46026
Actively Recruiting
21
Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
Adana, Turkey (Türkiye), 01250
Actively Recruiting
22
Memorial Ankara Hospital
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
23
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
24
Memorial Antalya Hospital
Antalya, Turkey (Türkiye), 07090
Actively Recruiting
25
Yeditepe University Hospital
Istanbul, Turkey (Türkiye), 34752
Actively Recruiting
26
Koc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, Turkey (Türkiye), 34010
Actively Recruiting
27
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
28
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
29
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
30
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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