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BNT327 + Chemotherapy for Non-Small Cell Lung Cancer
Houston, TX
Phase 2 & 3
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Must not have
Histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic component
Uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for non-small cell lung cancer in patients who are receiving treatment for the first time. The study is divided into two parts, each focusing on different types of lung cancer
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Who is the study for?
This trial is for adults with Stage IIIB/IIIC or IV non-small cell lung cancer (NSCLC) without certain genetic mutations. Participants should have at least one measurable lesion, be in good physical condition (ECOG 0-1), and have organs that are functioning well.Check my eligibility
What is being tested?
The study tests BNT327 combined with chemotherapy drugs like Paclitaxel, Pemetrexed, Carboplatin, and Pembrolizumab. It's a Phase 2/3 trial with two parts based on NSCLC subtypes and includes standard treatments plus the new drug.See study design
What are the potential side effects?
Possible side effects include reactions to infusion such as fever or chills, fatigue, hair loss from Paclitaxel; kidney issues from Pemetrexed; blood count changes from Carboplatin; immune-related effects from Pembrolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer is at an advanced stage and cannot be cured with surgery or radiotherapy, and it does not have specific genetic changes.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lung cancer has been confirmed by lab tests to have a small-cell component.
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My blood pressure or diabetes is not well-controlled.
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I haven't had serious wounds, ulcers, fractures, or risk of internal issues in the last 6 months.
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I have a bleeding disorder or a high risk of bleeding.
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I have symptoms related to major vein or spinal cord issues.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 2 - Best percentage change from baseline in tumor size
Phase 2 - Objective response rate (ORR) - unconfirmed
Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
+3 moreSecondary study objectives
Phase 2 - Disease Control Rate (DCR)
Phase 2 - Duration of Response (DOR)
Phase 2 - ORR - confirmed
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Substudy B Phase 3 - BNT327 + Carboplatin + PaclitaxelExperimental Treatment3 Interventions
BNT327 selected dose for Phase 3
Group II: Substudy B Phase 2 - BNT327 Dose 2 + Carboplatin + PaclitaxelExperimental Treatment3 Interventions
Group III: Substudy B Phase 2 - BNT327 Dose 1 + Carboplatin + PaclitaxelExperimental Treatment3 Interventions
Group IV: Substudy A Phase 3 - BNT327 + Carboplatin + PemetrexedExperimental Treatment3 Interventions
BNT327 selected dose for Phase 3
Group V: Substudy A Phase 2 - BNT327 Dose 2 + Carboplatin + PemetrexedExperimental Treatment3 Interventions
Group VI: Substudy A Phase 2 - BNT327 Dose 1 + Carboplatin + PemetrexedExperimental Treatment3 Interventions
Group VII: Substudy B Phase 3 - Pembrolizumab + Carboplatin + PaclitaxelActive Control3 Interventions
Group VIII: Substudy A Phase 3 - Pembrolizumab + Carboplatin + PemetrexedActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5450
Pemetrexed
2014
Completed Phase 3
~4980
Carboplatin
2014
Completed Phase 3
~6450
Find a Location
Closest Location:Clermont Oncology Center· Clermont, FL· 793 miles
Who is running the clinical trial?
BioNTech SELead Sponsor
82 Previous Clinical Trials
118,767 Total Patients Enrolled
Biotheus Inc.Industry Sponsor
19 Previous Clinical Trials
3,942 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
41 Previous Clinical Trials
11,385 Total Patients Enrolled