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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06712355




Registration number
NCT06712355
Ethics application status
Date submitted
11/11/2024
Date registered
2/12/2024

Titles & IDs
Public title
Safety and Effectiveness of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
Scientific title
A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer
Secondary ID [1] 0 0
2024-515765-34-00
Secondary ID [2] 0 0
BNT327-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive-stage Small-cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BNT327
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Etoposide
Treatment: Drugs - Carboplatin

Experimental: Arm 1 - Atezolizumab + Etoposide + Carboplatin -

Experimental: Arm 2 - BNT327 Dose 1 + Etoposide + Carboplatin -

Experimental: Arm 3 - BNT327 Dose 2 + Etoposide + Carboplatin -


Treatment: Drugs: BNT327
Solution for intravenous infusion

Treatment: Drugs: Atezolizumab
Concentrate for solution for intravenous infusion

Treatment: Drugs: Etoposide
Solution for infusion

Treatment: Drugs: Carboplatin
Solution for infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to approximately 39 months
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to approximately 39 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Up to approximately 39 months
Secondary outcome [3] 0 0
PFS rate based on investigator's assessment
Timepoint [3] 0 0
At 6, 12, and 18 months
Secondary outcome [4] 0 0
OS rate
Timepoint [4] 0 0
At 6, 12, 18, and 24 months
Secondary outcome [5] 0 0
Occurrence of treatment-emergent adverse events (TEAEs) including Grade =3, serious, and fatal TEAEs by relationship
Timepoint [5] 0 0
From the first dose of study treatment to the 90-Day Follow-up Visit
Secondary outcome [6] 0 0
Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs)
Timepoint [6] 0 0
From first to last dose of study treatment, i.e., up to 2 years
Secondary outcome [7] 0 0
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life Core 30 questionnaire (QLQ-C30) Global Health status/Quality-of-Life score (Items 29 and 30)
Timepoint [7] 0 0
Up to approximately 39 months
Secondary outcome [8] 0 0
Change from baseline in EORTC QLQ-C30 physical functioning
Timepoint [8] 0 0
Up to approximately 39 months
Secondary outcome [9] 0 0
Change from baseline in coughing scale of the EORTC quality-of-life-Lung cancer 29 questionnaire (QLQ-LC29)
Timepoint [9] 0 0
Up to approximately 39 months
Secondary outcome [10] 0 0
Change from baseline in shortness of breath scale of the EORTC QLQ-LC29
Timepoint [10] 0 0
Up to approximately 39 months
Secondary outcome [11] 0 0
Change from baseline in coughed up blood item of the EORTC QLQ-LC29
Timepoint [11] 0 0
Up to approximately 39 months
Secondary outcome [12] 0 0
Change from baseline in fatigue domain score scale of the NSCLC-SAQ
Timepoint [12] 0 0
Up to approximately 39 months
Secondary outcome [13] 0 0
Change from baseline in pain domain score of the Non-Small-Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Timepoint [13] 0 0
Up to approximately 39 months

Eligibility
Key inclusion criteria
* Have histologically or cytologically confirmed ES-SCLC (using the AJCC [American Joint Committee on Cancer] tumor node metastasis staging system combined with Veterans Administration Lung Study Group [VALG]'s two stage classification scheme).

* For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
* Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy or immunotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last systemic anticancer treatment including chemotherapy, radiotherapy, immunotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic and organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have histologically or cytologically confirmed SCLC with combined histologies.
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

* Within 2 weeks: small molecule agents with half-life of <7 days; radiation not involving the thoracic cavity; local radiation for brain lesions is allowed; local radiation for bone lesions is allowed.
* Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of =7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
* Have received prior treatment with a programmed death (ligand)-1 (PD[L]-1)/vascular endothelial growth factor (VEGF) bispecific antibody.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 10 days prior to the initiation of study treatment. 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 the following central nervous system metastases:

* Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
* Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids within 10 days before initiating study treatment of this study.
* Participants with known leptomeningeal metastases.
* Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
* Have serious non-healing wound, ulcer, or bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
* Have evidence of major coagulation disorders or other significant risks of hemorrhage such as:

* History of intracranial or intraspinal hemorrhage.
* Tumor lesions invading large vessels and with significant risk of bleeding.
* Had clinically significant hemoptysis or tumor hemorrhage within 1 month prior to the study treatment.
* Have superior vena cava syndrome or symptoms of spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
439
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [2] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioNTech SE
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Biotheus Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
BioNTech Responsible Person
Address 0 0
BioNTech SE
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BioNTech clinical trials patient information
Address 0 0
Country 0 0
Phone 0 0
+49 6131 9084
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06712355