Advanced Lung Cancer study: BNT324 vs BNT327
Official title A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
ClinicalTrials.gov ID: NCT06892548
What this study is testing
What is BNT324?
BNT324 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for advanced lung cancer.
Also referred to as DB-1311.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is looking to see if the two investigational drugs are safe and work against advanced or relapsed small cell and non‑small cell lung cancer.
- Who it's for
- Adults who have advanced, metastatic, relapsed, or progressive small cell lung cancer or non‑small cell lung cancer.
- What's involved
- Participants will receive the two study drugs and undergo regular clinic visits, scans and lab tests to monitor safety and response.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥18 years at the time of giving informed consent.
- Histological or cytological confirmed unresectable advanced/metastatic lung cancer.
- Part 1: Participants with NSCLC and SCLC
- Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
- Part 2 Cohort 2: Participants with SCLC, 2L+
You likely can't join if
- Prior treatment with B7-H3 targeted therapy.
- Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan).
- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce...
- Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or...
See the full eligibility criteria
- Aged ≥18 years at the time of giving informed consent.
- Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease.
- Part 1: Participants with NSCLC and SCLC
- Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
- Part 2 Cohort 2: Participants with SCLC, 2L+
- Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
- Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
- Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+
- Part 2 Cohort 6: Participants with NSCLC AGA positive
- Part 2 Cohort 7: Participants with SCLC, 1L
- Have measurable disease defined by RECIST version 1.1.
- Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Have a life expectancy of ≥12 weeks.
- Prior treatment with B7-H3 targeted therapy.
- Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan).
- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes...
- Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Iowa City, Iowa, United States
- Rochester, Minnesota, United States
- Belleville, New Jersey, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Tyler, Texas, United States
- Fairfax, Virginia, United States
- Camperdown, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Bendigo, Victoria, Australia
- Geelong, Victoria, Australia
+ 56 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Beverly Hills, California, United States; Los Angeles, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States and 70 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.