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Cancer Vaccine

BNT327 + Chemotherapy for Lung Cancer

Phase 2
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged ≥18 years at the time of giving informed consent.
Cohort 1 only: Have histologically or cytologically confirmed ES-SCLC (using the American Joint Committee on Cancer [AJCC]) tumor node metastasis [TNM] staging system combined with Veterans Administration Lung Study Group two-stage classification scheme). For AJCC TNM 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-dose to 21 days after study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a new treatment for two groups of people with small-cell lung cancer: those who haven't been treated before and those whose cancer has progressed after initial treatment.

Who is the study for?
This trial is for adults with untreated extended-stage small-cell lung cancer (ES-SCLC) or those whose SCLC has worsened after treatment. Participants must have a life expectancy over 3 months, an adequate neutrophil count, and at least one measurable lesion. Prior therapy recipients are eligible if they've had a 6-month break before ES-SCLC diagnosis.
What is being tested?
The study tests BNT327's safety and preliminary effectiveness in combination with chemotherapy drugs like Topoisomerase Inhibitors A & B, Taxane, and Alkylating agents. It includes patients who haven't been treated yet as well as those who've seen their cancer progress post-treatment.
What are the potential side effects?
Potential side effects of BNT327 may include typical chemotherapy-related issues such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have extensive-stage small cell lung cancer as confirmed by specific tests.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose to 21 days after study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose to 21 days after study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best percentage change from baseline in the tumor size
Objective Response Rate
Occurrence of dose interruption, reduction, and discontinuation of study treatment due to TEAEs
+2 more
Secondary study objectives
Disease Control Rate
Duration of Response
Incidence of detectable BNT327 antidrug antibodies in serum
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 3 Arm 2 - BNT327 DL2 + Topoisomerase Inhibitor BExperimental Treatment2 Interventions
Participants with SCLC who have disease progression/relapse
Group II: Cohort 3 Arm 1 - BNT327 DL1 + Topoisomerase Inhibitor BExperimental Treatment2 Interventions
Participants with SCLC who have disease progression/relapse
Group III: Cohort 2 Arm 2 - BNT327 DL2 + TaxaneExperimental Treatment2 Interventions
Participants with SCLC who have disease progression/relapse
Group IV: Cohort 2 Arm 1 - BNT327 DL1 + TaxaneExperimental Treatment2 Interventions
Participants with SCLC who have disease progression/relapse
Group V: Cohort 1 Arm 2 - BNT327 DL2 + Alkylating agent + Topoisomerase Inhibitor AExperimental Treatment3 Interventions
Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting
Group VI: Cohort 1 Arm 1 - BNT327 DL1 + Alkylating Agent + Topoisomerase Inhibitor AExperimental Treatment3 Interventions
Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Taxane
2015
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
71 Previous Clinical Trials
111,049 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
36 Previous Clinical Trials
9,878 Total Patients Enrolled
~27 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
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