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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06841055
Registration number
NCT06841055
Ethics application status
Date submitted
20/02/2025
Date registered
24/02/2025
Date last updated
29/08/2025
Titles & IDs
Public title
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy
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Scientific title
A Phase II, Multisite, Open-label, Single Arm Trial of BNT327 in Combination With Docetaxel in Second-line Stage IV Non-small Cell Lung Cancer (NSCLC) Following Chemoimmunotherapy
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Secondary ID [1]
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2024-518279-80-00
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Secondary ID [2]
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BNT327-07
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BNT327
Treatment: Drugs - Docetaxel
Experimental: Part 1A - BNT327 Dose 1 + docetaxel -
Experimental: Part 1B - BNT327 Dose 2 + docetaxel -
Experimental: Part 2 - Selected doses of BNT327 + docetaxel - Dose expansion at the deemed safe dose
Treatment: Drugs: BNT327
Intravenous infusion
Treatment: Drugs: Docetaxel
Intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1 - Occurrence of DLTs
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Assessment method [1]
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During the DLT evaluation period by dose level
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Timepoint [1]
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up to 21 days after first dose of investigational medicinal product (IMP)
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Primary outcome [2]
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Part 1 and Part 2 - Occurrence of BNT327 treatment emergent adverse events (TEAEs), treatment-related TEAEs, treatment emergent serious adverse events (TESAEs), treatment-related (TRSAEs), and adverse events of special interest (AESIs)
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Assessment method [2]
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Graded according to the (US) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
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Timepoint [2]
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from initiation of the first dose of IMP to the 90-day Follow-Up visit
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Primary outcome [3]
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Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and/or participant discontinuation due to adverse events (AEs)
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Assessment method [3]
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Timepoint [3]
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from initiation of the first dose of IMP until the 90-day Safety Follow-up visit
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Primary outcome [4]
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Part 1 and Part 2 - Objective response rate (ORR)
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Assessment method [4]
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Defined as the proportion 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 investigator's review) is observed as best overall response
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [1]
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Part 1 and Part 2 - Duration of Response (DOR)
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Assessment method [1]
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Defined as the time from first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease, per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first
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Timepoint [1]
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Up to approximately 2 years
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Secondary outcome [2]
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Part 1 and Part 2- Progression-free Survival (PFS)
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Assessment method [2]
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Based on the investigator's assessment defined as the time from first dose of IMP to the first objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first
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Timepoint [2]
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Up to approximately 2 years
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Secondary outcome [3]
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Part 1 and Part 2 - Depth of Response
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Assessment method [3]
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Defined as the maximum percent reduction from baseline in tumor size measured by sum of target lesion diameter (including nodal \[short axis\] and non-nodal \[longest axis\] lesions)
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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Part 1 and Part 2 - Disease Control Rate (DCR)
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Assessment method [4]
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Defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [5]
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Part 1 and Part 2 - Time to Response (TTR)
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Assessment method [5]
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Defined as the time from first dose of IMP to first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment)
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Part 1 and Part 2 - Overall Survival (OS)
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Assessment method [6]
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Defined as the time from first dose of IMP to death from any cause
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [7]
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Part 1 and Part 2 - PK assessment: Maximum concentration (Cmax) derived from serum concentration of BNT327
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Assessment method [7]
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Timepoint [7]
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from pre-dose to the end of study treatment (up to approximately 2 years)
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Secondary outcome [8]
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Part 1 and Part 2 - Number of participants developing detectable anti-BNT327 antibodies in serum
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Assessment method [8]
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Timepoint [8]
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from pre-dose to the end of study treatment (up to approximately 2 years)
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Eligibility
Key inclusion criteria
Key
* Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 [PD-1]/ programmed death ligand-1 [PD-L1] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 8th edition.
* Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this trial.
* Only one prior line of immunotherapy containing regimen is allowed in advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months.
* Historical PD-L1 results must be available.
* Patients with actionable genetic alterations are allowed to be enrolled if patients received locally approved and available targeted agent in combination with immunotherapy in first-line advanced/metastatic setting.
* Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be capped under 30% in the overall trial population.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the Screening Visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator.
* Eastern cooperative oncology group performance status of 0 or 1.
* Adequate organ function.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label).
* Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents.
* Have received more than one prior lines of therapies in advanced/metastatic setting.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* Have a serious non-healing wound, ulcer, or bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
* Participants with evidence of major coagulation disorders or other significant risks of hemorrhage.
* Have superior vena cava syndrome or symptoms of spinal cord compression
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2028
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
South Austrail
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Recruitment hospital [1]
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Cancer Research SA (CRSA) - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Kentucky
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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South Korea
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State/province [4]
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Gyeongsangnam-do
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Country [5]
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South Korea
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State/province [5]
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Cheongju-si
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Country [6]
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South Korea
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State/province [6]
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Incheon
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Country [7]
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United Kingdom
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State/province [7]
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Cardiff
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Country [8]
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United Kingdom
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State/province [8]
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Leeds
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Country [9]
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United Kingdom
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State/province [9]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BioNTech SE
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase II, multisite, open-label, single arm study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy. Part 1 is safety run-in with BNT327 (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of BNT327 plus docetaxel.
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Trial website
https://clinicaltrials.gov/study/NCT06841055
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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BioNTech Responsible Person
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Address
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BioNTech SE
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BioNTech clinical trials patient information
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Address
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Country
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Phone
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+49 6131 9084
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06841055
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