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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06712316




Registration number
NCT06712316
Ethics application status
Date submitted
11/11/2024
Date registered
2/12/2024
Date last updated
16/05/2025

Titles & IDs
Public title
Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Scientific title
A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer
Secondary ID [1] 0 0
2024-515764-31-00
Secondary ID [2] 0 0
BNT327-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-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 - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel

Experimental: Substudy A Phase 2 - BNT327 Dose 1 + Carboplatin + Pemetrexed -

Experimental: Substudy A Phase 2 - BNT327 Dose 2 + Carboplatin + Pemetrexed -

Experimental: Substudy A Phase 3 - BNT327 + Carboplatin + Pemetrexed - BNT327 selected dose for Phase 3

Active comparator: Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed -

Experimental: Substudy B Phase 2 - BNT327 Dose 1 + Carboplatin + Paclitaxel -

Experimental: Substudy B Phase 2 - BNT327 Dose 2 + Carboplatin + Paclitaxel -

Experimental: Substudy B Phase 3 - BNT327 + Carboplatin + Paclitaxel - BNT327 selected dose for Phase 3

Active comparator: Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel -


Treatment: Drugs: BNT327
Intravenous infusion

Treatment: Drugs: Pembrolizumab
Intravenous infusion

Treatment: Drugs: Carboplatin
Intravenous infusion

Treatment: Drugs: Pemetrexed
Intravenous infusion

Treatment: Drugs: Paclitaxel
Intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade =3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs
Assessment method [1] 0 0
For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in the combination treatment regimen.
Timepoint [1] 0 0
From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
Primary outcome [2] 0 0
Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
Assessment method [2] 0 0
For substudies A and B.
Timepoint [2] 0 0
From the first dose of IMP to the 90-day Follow-Up Visit
Primary outcome [3] 0 0
Phase 2 - Objective response rate (ORR) - unconfirmed
Assessment method [3] 0 0
For substudies A and B. ORR is defined as the proportion of participants in whom a 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.
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Phase 2 - Best percentage change from baseline in tumor size
Assessment method [4] 0 0
For substudies A and B. Based on investigator's tumor assessment according to RECIST 1.1.
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Phase 3 - Progression free survival (PFS) assessed by blinded independent central review (BICR)
Assessment method [5] 0 0
For substudies A and B PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.
Timepoint [5] 0 0
Up to approximately 5 years
Primary outcome [6] 0 0
Phase 3 - Overall survival (OS)
Assessment method [6] 0 0
For substudies A and B. OS defined as the time from randomization to death from any cause
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Phase 2 - ORR - confirmed
Assessment method [1] 0 0
For substudies A and B. ORR defined as the proportion of participants whom a CR or PR (per RECIST v1.1) is observed as best overall response with confirmation.
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Phase 2 - Duration of Response (DOR)
Assessment method [2] 0 0
For substudies A and B. DOR defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Phase 2 - Disease Control Rate (DCR)
Assessment method [3] 0 0
For substudies A and B. DCR defined as the proportion of participants in whom a CR or PR or stable disease (per RECIST v1.1, stable disease assessed at least 6 weeks after randomization) is observed as best overall response.
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Phase 3 - PFS assessed by investigator
Assessment method [4] 0 0
For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Phase 3 - ORR assessed by BICR and by the investigator
Assessment method [5] 0 0
For substudies A and B. ORR defined as the proportion of participants in whom a CR or PR (per RECIST v1.1) is observed as best overall response with confirmation.
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Phase 3 - DOR assessed by BICR and by the investigator
Assessment method [6] 0 0
For substudies A and B. DOR defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Phase 3 - DCR assessed by BICR and by the investigator
Assessment method [7] 0 0
For substudies A and B. DCR defined as the proportion of participants in whom a CR or PR or stable disease (per RECIST v1.1, stable disease assessed at least 6 weeks after randomization) is observed as best overall response.
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Phase 3 - PFS rate as assessed by BICR
Assessment method [8] 0 0
For substudies A and B.
Timepoint [8] 0 0
At 6, 12, and 18 months
Secondary outcome [9] 0 0
Phase 3 - PFS rate as assessed by investigator
Assessment method [9] 0 0
For substudies A and B.
Timepoint [9] 0 0
At 6, 12, and 18 months
Secondary outcome [10] 0 0
Phase 3 - OS rate
Assessment method [10] 0 0
For substudies A and B.
Timepoint [10] 0 0
At 6, 12, 18, 24 months
Secondary outcome [11] 0 0
Phase 3 - Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life-Core 30 Questionnaire (QLQ-C30)
Assessment method [11] 0 0
For substudies A and B. The EORTC QLQ-C30 is the most widely used cancer-specific, health related Quality-of-Life (QoL) instrument containing a total of 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for functional scale is high/healthy level of functioning; high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems).
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Phase 3 - Change from baseline in EORTC Lung Cancer-Specific QoL Questionnaire (QLC-LC29)
Assessment method [12] 0 0
For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health related QoL questionnaire module to be employed in conjunction with the QLQ-C30. It comprises of 29 items and measures 5 multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and 5 single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems.
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Phase 3 - Change from baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and domain score
Assessment method [13] 0 0
For substudies A and B. The NSCLC-SAQ is a 7-item patient reposted outcome (PRO) measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains 5 domains and accompanying items that were identified as symptoms of non-small cell lung cancer: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms.
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Phase 3 - Occurrence of TEAEs including Grade =3, serious, and fatal TEAEs by relationship
Assessment method [14] 0 0
For substudies A and B. AEs graded according to CTCAE v5.0.
Timepoint [14] 0 0
From the first dose of IMP to the 90-day Follow-Up Visit
Secondary outcome [15] 0 0
Phase 3 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
Assessment method [15] 0 0
For substudies A and B.
Timepoint [15] 0 0
From the first dose of IMP to the 90-day Follow-Up Visit

Eligibility
Key inclusion criteria
Key

* Have histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 8th edition without actionable EGFR mutation or anaplastic lymphoma kinase rearrangement.
* 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 organ function.

Key
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 NSCLC with small-cell lung cancer histologic component.
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

* Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody or received platinum-based chemotherapy and/or anti-PD(L)-1 as part of adjuvant or neoadjuvant treatment
* 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. 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. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing 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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
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
7/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
982
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cairns Hospital - Cairns
Recruitment hospital [2] 0 0
Dubbo Hospital - Dubbo
Recruitment hospital [3] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [4] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [5] 0 0
Western Health Sunshine Hospital - St Albans
Recruitment hospital [6] 0 0
ICON Cancer Care - Townsville - Townsville
Recruitment hospital [7] 0 0
Cancer Care Wollongong Pty Limited - Wollongong
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
2830 - Dubbo
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment postcode(s) [6] 0 0
4812 - Townsville
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Cheongju-si
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Daejeon
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Goyang-si
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Incheon
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Jinju-si
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Suwon-si
Country [15] 0 0
Turkey
State/province [15] 0 0
Ankara
Country [16] 0 0
Turkey
State/province [16] 0 0
Gaziantep
Country [17] 0 0
Turkey
State/province [17] 0 0
Istanbul
Country [18] 0 0
Turkey
State/province [18] 0 0
Kadiköy
Country [19] 0 0
Turkey
State/province [19] 0 0
Kecioren
Country [20] 0 0
Turkey
State/province [20] 0 0
Kocaeli
Country [21] 0 0
Turkey
State/province [21] 0 0
Kucukcekmece
Country [22] 0 0
Turkey
State/province [22] 0 0
Sakarya
Country [23] 0 0
Turkey
State/province [23] 0 0
Samsun
Country [24] 0 0
Turkey
State/province [24] 0 0
Seyhan
Country [25] 0 0
Turkey
State/province [25] 0 0
Yenimahalle
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Cardiff
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cottingham
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Oxford
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Preston
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
BioNTech Responsible Person
Address 0 0
BioNTech SE
Country 0 0
Phone 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
Email 0 0
patients@biontech.de
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/NCT06712316