BNT327 + Chemotherapy for Lung Cancer

Not currently recruiting at 98 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioNTech SE

Must not be taking: Corticosteroids, Antibiotics, Immunotherapy, others

Disqualifiers: Pregnancy, Autoimmune diseases, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BNT327 for individuals with small-cell lung cancer (SCLC). It aims to assess the safety and effectiveness of BNT327, particularly when combined with chemotherapy drugs such as carboplatin, etoposide, paclitaxel, or topotecan. The trial includes participants who have either not yet received treatment for extended-stage SCLC or whose cancer has returned or worsened after previous treatments. Eligible participants should have untreated advanced-stage lung cancer or have experienced cancer progression after initial therapy. Participants must be prepared to attend regular study visits and adhere to the treatment plan.

As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in SCLC treatment.

Do I need to stop my current medications to join the trial?

The protocol does not specify if you need to stop your current medications. However, certain treatments like systemic corticosteroids, live vaccines, and some antibiotics must be stopped within specific timeframes before starting the trial. It's best to discuss your current medications with the trial team.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain treatments, like systemic corticosteroids above a specific dose and some recent therapies, are not allowed before starting the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, BNT327 combined with chemotherapy drugs like carboplatin and etoposide showed promising results for small-cell lung cancer (SCLC). The combination was generally well-tolerated, with most side effects being mild to moderate, such as nausea and tiredness. Serious side effects were less common.

For BNT327 with paclitaxel, earlier research showed it was generally safe. Some patients experienced common chemotherapy side effects, like hair loss and low blood cell counts, but these were expected and manageable.

While specific data for BNT327 with topotecan is limited, earlier studies suggest BNT327 is promising in various treatments, indicating it might also be well-tolerated when used with topotecan.

Overall, BNT327 appears to be a safe option when combined with different chemotherapy drugs, although side effects can vary. Participants should discuss potential risks with trial coordinators. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for lung cancer?

Unlike the standard treatments for small cell lung cancer (SCLC), which typically involve chemotherapy drugs like carboplatin, etoposide, and topotecan, BNT327 represents a novel approach. Researchers are excited about BNT327 because it targets a specific mechanism involved in cancer cell growth, potentially improving effectiveness when combined with existing chemotherapy drugs. This targeted action might offer enhanced outcomes for patients, especially those with disease progression or relapse, by working synergistically with chemotherapy to attack cancer cells more efficiently. Additionally, BNT327's unique mechanism could lead to fewer side effects compared to traditional therapies, making it a promising option for improving patient quality of life.

What evidence suggests that this trial's treatments could be effective for small-cell lung cancer?

This trial will evaluate BNT327 combined with various chemotherapy drugs for treating small-cell lung cancer (SCLC). Participants in different arms of this trial will receive BNT327 with either carboplatin and etoposide, paclitaxel, or topotecan. Studies have shown promising results for BNT327 when combined with these standard chemotherapy drugs. Specifically, when researchers combined BNT327 with carboplatin and etoposide, patients with extensive-stage SCLC experienced better outcomes. Research also indicates that using BNT327 with paclitaxel in patients whose cancer worsened after initial treatments led to positive results. Lastly, early data suggests that BNT327 with topotecan might help those with relapsed SCLC. These findings highlight BNT327's potential to improve treatment results in different SCLC situations. ^{1 2 3 5 6}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can follow the study's schedule and requirements.

I have signed the consent form for this study.

I have at least one tumor that can be measured and has not been treated locally.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BNT327 in combination with chemotherapy until disease progression, intolerable toxicity, patient withdrawal, study termination, or up to 2 years

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months after completion of study treatment

What Are the Treatments Tested in This Trial?

Interventions

• BNT327

Trial Overview

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.

How Is the Trial Designed?

Group I: Cohort 3 Arm 2 - BNT327 DL2 + topotecan Experimental Treatment 2 Interventions

Participants with SCLC who have disease progression/relapse

Group II: Cohort 3 Arm 1 - BNT327 DL1 + topotecan Experimental Treatment 2 Interventions

Participants with SCLC who have disease progression/relapse

Group III: Cohort 2 Arm 2 - BNT327 DL2 + paclitaxel Experimental Treatment 2 Interventions

Participants with SCLC who have disease progression/relapse

Group IV: Cohort 2 Arm 1 - BNT327 DL1 + paclitaxel Experimental Treatment 2 Interventions

Participants with SCLC who have disease progression/relapse

Group V: Cohort 1 Arm 2 - BNT327 DL2 + carboplatin + etoposide Experimental Treatment 3 Interventions

Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting

Group VI: Cohort 1 Arm 1 - BNT327 DL1 + carboplatin + etoposide Experimental Treatment 3 Interventions

Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Published Research Related to This Trial

Lung cancer remains the leading cause of cancer-related deaths in the U.S. for individuals over 35, highlighting the urgent need for more effective treatments beyond standard chemotherapy.

Several new agents, including paclitaxel and gemcitabine, have demonstrated significant effectiveness in treating non-small cell lung cancer, suggesting promising avenues for future research and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Agents in Non-Small Cell Lung Cancer. Feigal, EG.[2019]

Platinum-containing doublet chemotherapy combinations have become the standard treatment for advanced non-small cell lung cancer (NSCLC), showing a survival advantage for patients diagnosed at later stages.

Recent studies indicate that nonplatinum combinations and the addition of bevacizumab to existing regimens can further improve patient outcomes, while ongoing research is exploring maintenance therapies and second-line treatments like docetaxel and pemetrexed for refractory cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy for advanced stage non-small cell lung cancer. Fathi, AT., Brahmer, JR.[2008]

Cytotoxic chemotherapy for advanced non-small cell lung cancer (NSCLC) provides only limited benefits, such as modest survival prolongation and symptom relief, compared to best supportive care alone.

There is a need for new treatment approaches, as traditional chemotherapy has reached a plateau in efficacy and safety; targeted therapies that focus on specific cancer cell pathways may offer a promising alternative for improving NSCLC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapy in non-small cell lung cancer. Giaccone, G.[2019]

A variety of new agents, including taxanes, gemcitabine, and irinotecan, have shown promise in early clinical studies for treating non-small-cell lung cancer (NSCLC), indicating potential for improved treatment options.

Cisplatin remains a key component in combination therapies for NSCLC, being tested alongside these new agents, radiation, and surgery in numerous trials to enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy in metastatic non-small-cell lung cancer. Sandler, A.[2022]

Recent meta-analysis indicates that while alkylating agents negatively impact survival in non-small cell lung cancer (NSCLC), cisplatin-containing regimens provide a modest survival benefit.

The review highlights several promising cytotoxic agents, such as vinorelbine and docetaxel, which show potential for improving treatment outcomes in advanced NSCLC, emphasizing the need for new drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combination chemotherapy in the treatment of inoperable non-small cell lung cancer]. Masuda, N.[2022]

Recent advancements in targeted therapies for advanced non-small cell lung cancer have shown promise, with agents like docetaxel, pemetrexed, and erlotinib undergoing phase III trials to assess their effectiveness after previous treatments.

The review emphasizes the importance of identifying predictors of favorable outcomes to guide treatment selection, highlighting ongoing pivotal trials that may shape future strategies in managing this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing therapy in previously treated non-small cell lung cancer. Miller, VA.[2018]

The combination of ABT-751 and carboplatin significantly reduced lung cancer cell growth and induced cell death in preclinical studies, suggesting a potential effective treatment strategy.

In a phase I study with 20 advanced NSCLC patients, the maximum tolerated dose was determined to be ABT-751 125 mg twice daily, with modest clinical activity observed, including a median overall survival of 11.7 months and two confirmed partial responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I trial and in vitro studies combining ABT-751 with carboplatin in previously treated non-small cell lung cancer patients. Ma, T., Fuld, AD., Rigas, JR., et al.[2021]

In a study involving 15 patients with advanced non-small cell lung cancer (NSCLC) who had previously undergone chemotherapy, the novel antitumor agent MGI-114 showed no objective tumor responses, leading to the conclusion that it is not effective as a second-line treatment.

The treatment was associated with significant side effects, including grade 2 or higher thrombocytopenia in 40% of patients, and grade 3 nausea and grade 2 vomiting in 40% and 47% of patients, respectively, indicating safety concerns with this dosing regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with advanced non-small cell cancer previously treated with chemotherapy. Dowell, JE., Johnson, DH., Rogers, JS., et al.[2019]

Only a few traditional chemotherapeutic agents have shown single-agent response rates greater than 15% in treating non-small-cell lung cancer (NSCLC), indicating limited effectiveness with standard treatments.

Recent phase I/II trials have identified new drugs, such as navelbine, CTP-11, topotecan, and taxol, that have achieved single-agent response rates above 20%, suggesting improved treatment options for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions for chemotherapy in non-small-cell lung cancer. Green, MR.[2019]

Current standard treatment for advanced non-small-cell lung cancer involves doublet chemotherapy, which has shown 1-year survival rates of approximately 35% and 2-year survival rates of about 15%.

Preliminary studies indicate that triplet therapy may enhance survival rates compared to double therapy, with toxicity rates being low enough to support the development of these three-drug combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triplet combination chemotherapy and targeted therapy regimens. Bunn, PA.[2005]

In a phase II trial involving 51 patients with metastatic non-small-cell lung cancer (NSCLC), VP-16-213 showed a low overall response rate of only 4%, with partial responses occurring exclusively in previously untreated patients.

The treatment was associated with significant side effects, including myelosuppression and two drug-related deaths from septicemia, indicating that while it has minimal efficacy, it also poses safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of VP-16-213 in non-small-cell lung cancer. Itri, LM., Gralla, RJ., Chapman, RA., et al.[2013]

Citations

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Study Details | NCT06449209 | Safety, Preliminary ...

This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC)

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ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS8129

A global phase III, double-blind, randomized trial of ...

This Phase III trial will further assess the efficacy and safety of BNT327 in combination with chemo for previously untreated pts with ES-SCLC in a global ...

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This is a Phase III, multisite, randomized, double-blinded study to investigate BNT327 combined with chemotherapy (etoposide/carboplatin)

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Phase 2 study of the efficacy and safety of BNT327/PM8002 ...

extensive-stage small-cell lung cancer. (ES-SCLC). Trial design. Presented at the European Lung Cancer Congress (ELCC 2025), Paris, France. Background. Ying ...

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A randomized phase 3 trial in first-line extensive-stage small-cell lung cancer of BNT327 in combination with chemotherapy. Targeted Disease(s): Lung Cancer.

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Safety and Effectiveness of BNT327 With Chemotherapy ...

This is a Phase III, multisite, randomized, double-blinded study to investigate BNT327 combined with chemotherapy (etoposide/carboplatin) compared to ...