A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT07111520 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: BNT326-022024-519344-32-001011576
• Study Type: interventional
• Target: 880
• Locations: 10 countries
• Sites: 85

Brief Summary

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available). The main goals of this study are:

1. 1.To find the best dose levels (DLs) for the combination of BNT326 and pumitamig.
2. 2.To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are).
3. 3.To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.

Conditions

Non-small Cell Lung Cancer

Keywords

Combination with other investigational agents; Programmed death-ligand 1 (PD-L1); Antibody-drug conjugate (ADC); Human epidermal growth factor receptor 3 (HER3); Programmed Death-1 (PD-1); Programmed Death-1 monoclonal antibodies; Anti vascular endothelial growth factor-A (anti-VEGF-A); Bispecific antibody; Immunotherapy; Dose optimization; Time to progression; Vascular endothelial growth factor (VEGF)

Outcome Measures

Primary Outcomes (4)

• Part 1 - Occurrence of dose limiting toxicities (DLTs) within a participant

  During the DLT evaluation period by dose level

  21 days starting on Day 1 of Cycle 1

• Part 1 and Part 2a - Occurrence of treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAE), treatment emergent serious adverse events (TESAE), treatment-related serious adverse events (TRSAE)

  from the first dose of investigational medicinal product (IMP) up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)

• Part 1 and Part 2a - Occurrence of dose interruption, reduction, and discontinuation due to TEAEs

  from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)

• Part 2a and Part 2b - Objective response rate (ORR)

  Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.

  from the time of initiation of the first dose of IMP to approximately 36 months

Secondary Outcomes (11)

• Part 1 - ORR

  from the time of initiation of the first dose of IMP to approximately 36 months

• Part 2b - Occurrence of TEAEs, TRAEs, TESAEs, TRSAEs

  from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)

• Part 2b - Occurrence of dose interruption, reduction, and discontinuation due to TEAEs

  from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)

• Part 2a and Part 2b - Progression free survival based on the investigator's assessment

  from the first dose of IMP to approximately 36 months

• Part 2a and Part 2b - Disease control rate

  from the first dose of IMP to approximately 36 months

Study Arms (25)

Part 1 - BNT326 (DL1) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig, starting dose. In participants with second-line (or higher) 2L(+), squamous or non-squamous NSCLC, actionable genomic alterations (AGA)-negative/positive, any programmed death-ligand 1 (PD-L1).

Drug: BNT326; Drug: Pumitamig

Part 1 - BNT326 (DL2) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 1 - BNT326 (DL3) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 1 - BNT326 (DL1) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 1 - BNT326 (DL2) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 1 - BNT326 (DL3) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort A, Arm 1) - BNT326 (DL1) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort A, Arm 2) - BNT326 (DL2) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort A, Arm 3) - BNT326 (DL3) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort A, Arm 4) - BNT326 (DL1) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort A, Arm 5) - BNT326 (DL2) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort A, Arm 6) - BNT326 (DL3) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort B, Arm 1) - BNT326 (DL1) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with first-line (1L) squamous or non-squamous NSCLC, AGA-negative, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort B, Arm 2) - BNT326 (DL2) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort B, Arm 3) - BNT326 (DL3) + pumitamig (DL1)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort B, Arm 4) - BNT326 (DL1) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort B, Arm 5) - BNT326 (DL2) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2a (Cohort B, Arm 6) - BNT326 (DL3) + pumitamig (DL2)

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.

Drug: BNT326; Drug: Pumitamig

Part 2b (Cohort C, Arm 1) - BNT326 + pumitamig

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or epithelial growth factor receptor (EGFR) activating mutation, any PD-L1. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Drug: BNT326; Drug: Pumitamig

Part 2b (Cohort C, Arm 2) - BNT326 + pumitamig

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Drug: BNT326; Drug: Pumitamig

Part 2b (Cohort D1, Arm 1) - BNT326 + pumitamig

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Drug: BNT326; Drug: Pumitamig

Part 2b (Cohort D1, Arm 2) - BNT326 + pumitamig

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Drug: BNT326; Drug: Pumitamig

Part 2b (Cohort D1, Arm 3) - Pumitamig monotherapy

EXPERIMENTAL

Pumitamig monotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DL used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Drug: Pumitamig

Part 2b (Cohort D2, Arm 1) - BNT326 + pumitamig

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Drug: BNT326; Drug: Pumitamig

Part 2b (Cohort D2, Arm 2) - BNT326 + pumitamig

EXPERIMENTAL

Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Drug: BNT326; Drug: Pumitamig

Interventions

BNT326 DRUG

intravenous (IV) infusion

Part 1 - BNT326 (DL1) + pumitamig (DL1); Part 1 - BNT326 (DL1) + pumitamig (DL2); Part 1 - BNT326 (DL2) + pumitamig (DL1); Part 1 - BNT326 (DL2) + pumitamig (DL2); Part 1 - BNT326 (DL3) + pumitamig (DL1); Part 1 - BNT326 (DL3) + pumitamig (DL2); Part 2a (Cohort A, Arm 1) - BNT326 (DL1) + pumitamig (DL1); Part 2a (Cohort A, Arm 2) - BNT326 (DL2) + pumitamig (DL1); Part 2a (Cohort A, Arm 3) - BNT326 (DL3) + pumitamig (DL1); Part 2a (Cohort A, Arm 4) - BNT326 (DL1) + pumitamig (DL2); Part 2a (Cohort A, Arm 5) - BNT326 (DL2) + pumitamig (DL2); Part 2a (Cohort A, Arm 6) - BNT326 (DL3) + pumitamig (DL2); Part 2a (Cohort B, Arm 1) - BNT326 (DL1) + pumitamig (DL1); Part 2a (Cohort B, Arm 2) - BNT326 (DL2) + pumitamig (DL1); Part 2a (Cohort B, Arm 3) - BNT326 (DL3) + pumitamig (DL1); Part 2a (Cohort B, Arm 4) - BNT326 (DL1) + pumitamig (DL2); Part 2a (Cohort B, Arm 5) - BNT326 (DL2) + pumitamig (DL2); Part 2a (Cohort B, Arm 6) - BNT326 (DL3) + pumitamig (DL2); Part 2b (Cohort C, Arm 1) - BNT326 + pumitamig; Part 2b (Cohort C, Arm 2) - BNT326 + pumitamig; Part 2b (Cohort D1, Arm 1) - BNT326 + pumitamig; Part 2b (Cohort D1, Arm 2) - BNT326 + pumitamig; Part 2b (Cohort D2, Arm 1) - BNT326 + pumitamig; Part 2b (Cohort D2, Arm 2) - BNT326 + pumitamig

Pumitamig DRUG

IV infusion

Also known as: BNT327, PM8002

Part 1 - BNT326 (DL1) + pumitamig (DL1); Part 1 - BNT326 (DL1) + pumitamig (DL2); Part 1 - BNT326 (DL2) + pumitamig (DL1); Part 1 - BNT326 (DL2) + pumitamig (DL2); Part 1 - BNT326 (DL3) + pumitamig (DL1); Part 1 - BNT326 (DL3) + pumitamig (DL2); Part 2a (Cohort A, Arm 1) - BNT326 (DL1) + pumitamig (DL1); Part 2a (Cohort A, Arm 2) - BNT326 (DL2) + pumitamig (DL1); Part 2a (Cohort A, Arm 3) - BNT326 (DL3) + pumitamig (DL1); Part 2a (Cohort A, Arm 4) - BNT326 (DL1) + pumitamig (DL2); Part 2a (Cohort A, Arm 5) - BNT326 (DL2) + pumitamig (DL2); Part 2a (Cohort A, Arm 6) - BNT326 (DL3) + pumitamig (DL2); Part 2a (Cohort B, Arm 1) - BNT326 (DL1) + pumitamig (DL1); Part 2a (Cohort B, Arm 2) - BNT326 (DL2) + pumitamig (DL1); Part 2a (Cohort B, Arm 3) - BNT326 (DL3) + pumitamig (DL1); Part 2a (Cohort B, Arm 4) - BNT326 (DL1) + pumitamig (DL2); Part 2a (Cohort B, Arm 5) - BNT326 (DL2) + pumitamig (DL2); Part 2a (Cohort B, Arm 6) - BNT326 (DL3) + pumitamig (DL2); Part 2b (Cohort C, Arm 1) - BNT326 + pumitamig; Part 2b (Cohort C, Arm 2) - BNT326 + pumitamig; Part 2b (Cohort D1, Arm 1) - BNT326 + pumitamig; Part 2b (Cohort D1, Arm 2) - BNT326 + pumitamig; Part 2b (Cohort D1, Arm 3) - Pumitamig monotherapy; Part 2b (Cohort D2, Arm 1) - BNT326 + pumitamig; Part 2b (Cohort D2, Arm 2) - BNT326 + pumitamig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.
• Have measurable disease defined by RECIST v1.1.
• Have Eastern Cooperative Oncology Group performance status of 0 or 1.
• Have adequate organ and bone marrow function within 7 days before randomization/enrollment as defined in the protocol.
• Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSCLC.
• Part 1, 2L+, squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1 (NOTE: regimens used as neoadjuvant and/or adjuvant treatment may be considered as prior lines for advanced disease if relapse occurred within 6 months of the last dose.)
• for AGA-negative NSCLC only:
• Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
• Have experienced relapse or progression during or after treatment with standard systemic therapy in the advanced/metastatic setting or discontinued from prior therapy due to intolerance.
• Participants must have received 1 to 3 lines of systemic treatment in the metastatic setting, which can include anti-PD-1/PD-L1 therapy, chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently or sequentially. However, prior chemotherapy treatment must be limited to 2 lines or less.
• for AGA-positive NSCLC only (excluding EGFR activating mutation):
• Have documented positive test results for one or more actionable genomic alteration: EGFR (other than activating mutations), ALK, ROS proto-oncogene 1 (ROS1), gene encoding the hepatocyte growth factor receptor (MET), human gene that encodes a protein called B-Raf (BRAF), rearranged during transfection (RET), neurotrophic tropomyosin-receptor kinase (NTRK), human epidermal growth factor receptor 2 (HER2), Kirsten rat sarcoma virus (KRAS), or other genomic alteration with available targeted therapy.
• Must have received at least one prior systemic therapy for advanced disease, which must have included targeted treatment for actionable genomic alterations, which include alterations such as EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other alterations for which targeted therapies are available as a part of local SoC.
• Participants may have received between 1 to 3 lines of systemic treatment of anti-PD-1/PD-L1 therapy, chemotherapy, and/or anti-angiogenic agents. These treatments may be administered concurrently (including with tyrosine kinase inhibitor \[TKI\]) or sequentially. However, chemotherapy treatment must be limited to 2 lines or less.
• Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.

You may not qualify if:

• Had disease progression on or were intolerant to prior treatment with an agent targeting HER3 (including antibody, ADC, cell therapy, and other drugs) or with a topoisomerase I inhibitor payload (including topoisomerase I inhibitor-containing ADCs). Note: For Part 2a Cohort A, prior exposure to agents targeting HER3 or topoisomerase I inhibitor payload may be allowed on a case-by-case basis after discussion with and approval by the sponsor.
• Have an uncontrolled concomitant or intercurrent illness, that contra-indicates study participation, limits compliance with study procedures or substantially increases the risk of incurring AEs, including:
• Bleeding diathesis or active hemorrhage
• Clinically significant active infection, including respiratory viral infection
• Child-Pugh class B or C cirrhosis
• Known pulmonary disease with significant impact in lung function and/or with potential risk of severe infection
• Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior vena cava syndrome, carcinoid syndrome that is unstable and with available alternative therapies)
• Psychiatric or abuse condition
• Infectious colitis Grade ≥2 not resolved to Grade 1 within 72 h within the past 3 months
• Have left ventricular ejection fraction \<50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment.
• Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.
• Have a history of (non-infectious) interstitial lung disease (ILD) /pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. Asymptomatic interstitial changes caused by previous radiation therapy, chemotherapy, or other factors such as smoking are acceptable.
• Have had exposure to protocol-specific treatments with a washout period before randomization/enrollment.
• Have clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
• Are participants of childbearing potential who are pregnant or breastfeeding or are planning pregnancy within the time specified in the protocol or are potentially fertile males, who are planning to father children during the study or within the time specified in the protocol.

Sponsors & Collaborators

• BioNTech SE: lead
• MediLink Therapeutics (Suzhou) Co., Ltd.: collaborator

Study Sites (85)

UCLA Hematology Oncology - Main Site

Los Angeles, California, 90095, United States

RECRUITING

Stanford Cancer Institute

Stanford, California, 94305, United States

RECRUITING

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

Georgetown University - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Moffit Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Cancer Research SA

Adelaide, 5000, Australia

RECRUITING

St George Private Hospital

Kogarah, 2217, Australia

RECRUITING

Royal North Shore Hospital

Saint Leonards, 2065, Australia

RECRUITING

Mater

South Brisbane, 4101, Australia

RECRUITING

John Flynn Private Hospital

Tugun, 4224, Australia

RECRUITING

Westmead Hospital

Westmead, 2145, Australia

RECRUITING

Affiliated Hospital of Hebei University

Baoding, 071000, China

RECRUITING

Beijing GoBroad Hospital

Beijing, 102200, China

RECRUITING

The First Hospital of Jilin University

Changchun, 130021, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, 611135, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, 400030, China

RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, 350014, China

RECRUITING

The First Affiliated Hospital School of Clinical Medicine of Guangdong Pharmaceutical University

Guangzhou, 510080, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510163, China

RECRUITING

Anhui Chest Hospital

Hefei, 230022, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

RECRUITING

Anhui Provincial Cancer Hospital

Hefei, 230088, China

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, 230601, China

RECRUITING

Jinan Central Hospital

Jinan, 250013, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, 330006, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, 330006, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, 266003, China

RECRUITING

Shanghai East Hospital

Shanghai, 200120, China

RECRUITING

Shanghai GoBroad Cancer Hospital

Shanghai, 200120, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300060, China

RECRUITING

Hubei Cancer Hospital

Wuhan, 430079, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, 441138, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, 453100, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, 221009, China

RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, 225001, China

RECRUITING

Universitätsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

RECRUITING

Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo

Alessandria, 15100, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)

Catania, 95123, Italy

RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

RECRUITING

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 138, Italy

RECRUITING

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, 2025, Moldova

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Pratia MCM Krakow

Krakow, 30-727, Poland

RECRUITING

Centrum Medyczne Pratia Poznan

Poznan, 60-192, Poland

RECRUITING

Med-Polonia Sp. z o.o.

Poznan, 60-693, Poland

RECRUITING

Provita Prolife

Tomaszów Mazowiecki, 97-200, Poland

RECRUITING

Hospital Universitari Dexeus

Barcelona, 08028, Spain

RECRUITING

Hospital Universitari Vall d'Hebron - VHIO

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario HM Madrid Sanchinarro

Madrid, 28050, Spain

RECRUITING

Pratia ES Hospital Universitario de Torrejon

Madrid, 28850, Spain

RECRUITING

Clinica Universidad de Navarra

Madrid, 31008, Spain

RECRUITING

Hospital Quironsalud Malaga

Málaga, 29004, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Medical Park Seyhan Hospital

Adana, 01140, Turkey (Türkiye)

RECRUITING

Adana City Hospital

Adana, 01230, Turkey (Türkiye)

RECRUITING

Baskent University Adana Application and Research Center

Adana, 01240, Turkey (Türkiye)

RECRUITING

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Dr. Abdurrahman Yurtaslan Ankara Oncology Research and Training Hospital, Clinical Research Center

Ankara, 06105, Turkey (Türkiye)

RECRUITING

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

RECRUITING

Ankara Memorial Hospital

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Memorial Antalya Hastanesi

Antalya, 07020, Turkey (Türkiye)

RECRUITING

Yeditepe University Medical School Hospital

Istanbul, 31755, Turkey (Türkiye)

RECRUITING

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Mersin City Education and Research Hospital

Mersin, 33330, Turkey (Türkiye)

RECRUITING

Sakarya Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

RECRUITING

Royal Free Hospital

London, NW3 2QG, United Kingdom

RECRUITING

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

Northern Centre for Cancer Care

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Royal Marsden Hospital-Sutton

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lethal Congenital Contracture Syndrome 2

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); DE (3); IT (5); AU (6); PL (5); ES (12); TU (13); GB (4); MO (1); CN (25)