BNT327 + Docetaxel for Lung Cancer

Recruiting at 25 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioNTech SE

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Uncontrolled hypertension, Diabetes, Coagulation disorders, 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: 90

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for advanced lung cancer that has returned or worsened after initial treatment. The study combines BNT327, an experimental drug, with docetaxel, a standard chemotherapy drug, to assess safety and effectiveness. It is open to individuals with advanced non-small cell lung cancer who have previously received a specific type of chemoimmunotherapy and experienced disease progression. Participants must have at least one measurable cancer spot and good overall organ function. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken certain treatments like anti-VEGF antibodies or high-dose corticosteroids recently. It's best to discuss your current medications with the trial team.

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

Earlier research found that pumitamig (BNT327) combined with chemotherapy had a manageable safety profile, with most side effects being mild and only a few participants needing to stop treatment. Another study with pumitamig and paclitaxel showed similar results, revealing no new safety concerns.

For docetaxel, already approved for cancer treatment, side effects are well-known and typically include hair loss and tiredness. Since pumitamig has been well-tolerated in other studies, combining it with docetaxel appears promising from a safety standpoint. However, individual experiences may vary, so discussing any concerns with a healthcare professional is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about BNT327 combined with docetaxel for lung cancer because it represents a novel approach to treatment. Unlike the standard chemotherapy options that primarily target rapidly dividing cells, BNT327 is designed to work with docetaxel to enhance its efficacy. This combination could potentially improve outcomes by specifically targeting cancer cells more effectively while minimizing harm to healthy tissues. This innovative strategy offers hope for better management of lung cancer, making it a promising development in the field.

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

Research has shown that pumitamig (BNT327) holds promise for treating advanced lung cancer. In this trial, participants will receive pumitamig combined with docetaxel. Studies have found pumitamig effective with chemotherapy, as patients have shown positive responses. Recent findings revealed that when pumitamig was combined with paclitaxel, patients lived about 6.8 months without disease progression. This suggests that pumitamig, especially with chemotherapy like docetaxel, could benefit patients with advanced lung cancer. These results indicate that pumitamig might be a valuable treatment option in this context. ^{1 2 3 4 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 Stage IV Non-Small Cell Lung Cancer (NSCLC) that worsened after first-line chemoimmunotherapy. Participants must have had at least two cycles of immunotherapy, a documented PD-L1 result, and only one prior line of immunotherapy in the advanced setting. They should be physically capable (performance status 0 or 1) and have proper organ function.

Inclusion Criteria

I have completed at least two cycles of immunotherapy as my first treatment.

I have at least one tumor that can be measured on scans.

My cancer's PD-L1 test results are available.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Part 1 is a safety run-in with BNT327 (Dose 1 or Dose 2) plus docetaxel, including up to 12 participants treated in Part 1A and 1B sequentially

3 weeks

Multiple visits for dose administration and monitoring

Dose Expansion

Part 2 is a dose expansion at the deemed safe dose of BNT327 plus docetaxel

Up to 2 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for disease progression, new anticancer treatments, and survival status after completion of study treatment

90 days

Follow-up visit at 90 days

What Are the Treatments Tested in This Trial?

Interventions

• BNT327

Trial Overview The study tests BNT327 combined with docetaxel chemotherapy in patients whose NSCLC progressed post-chemoimmunotherapy. It's an open-label Phase II trial with two parts: initial safety run-in to determine safe doses followed by dose expansion using the established safe dose.

How Is the Trial Designed?

Group I: Part 2 - Selected doses of pumitamig + docetaxel Experimental Treatment 2 Interventions

Dose expansion at the deemed safe dose

Group II: Part 1B - Pumitamig Dose 2 + docetaxel Experimental Treatment 2 Interventions

Group III: Part 1A - Pumitamig Dose 1 + docetaxel Experimental Treatment 2 Interventions

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

In a phase I/II study involving 19 patients with unresectable non-small cell lung cancer (NSCLC), the combination of docetaxel and vinorelbine showed promising antitumor activity, with a 26% partial response rate and 47% of patients experiencing stable disease.

The treatment regimen had a low incidence of hematologic toxicity, with only 2.5% of cycles resulting in febrile neutropenia, indicating that this combination can be safely administered with granulocyte-colony stimulating factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) and vinorelbine in the treatment of advanced non-small cell lung cancer: preliminary results of a phase I/II trial. Miller, VA.[2018]

Docetaxel is recognized as one of the most effective cytotoxic drugs for treating non-small cell lung cancer, with ongoing clinical investigations exploring its use in combination therapies and radiotherapy.

Current studies at our hospital include trials combining docetaxel with gemcitabine and ifosfamide, as well as a planned randomized study to evaluate its effectiveness in conjunction with chemoradiotherapy for patients with inoperable stage III non-small cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in non-small cell lung cancer: ongoing studies in Heidelberg and future plans. Manegold, C.[2022]

Docetaxel is an effective treatment for non-small cell lung cancer (NSCLC), showing comparable efficacy to newer platinum-based therapies in advanced stages, and has been approved for use in this context.

Clinical trials are ongoing to explore the best ways to combine docetaxel with other treatments, such as thoracic radiotherapy and molecularly targeted agents, to enhance its effectiveness in various stages of NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel in non-small cell lung cancer: a review. Davies, AM., Lara, PN., Mack, PC., et al.[2019]

The recommended dose of docetaxel in combination with the oral drug S-1 was determined to be 40 mg/m², and this regimen showed a 24.1% overall response rate in previously treated non-small cell lung cancer patients, with a median overall survival of 11.8 months.

While the treatment was generally well tolerated, it did result in significant hematologic toxicities, including neutropenia in 34.5% of patients, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II study of docetaxel and S-1 in patients with previously treated non-small cell lung cancer. Atagi, S., Kawahara, M., Kusunoki, Y., et al.[2018]

Citations

1. investors.biontech.de investors.biontech.de/news-releases/news-release-details/first-disclosure-global-interim-phase-2-data-biontech-and

Press Release - BioNTech PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients ...

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

A global phase III, double-blind, randomized trial of ... Preliminary results from a Phase II trial showed encouraging efficacy results and a manageable safety profile for BNT327 with paclitaxel as ...

3. jto.org jto.org/article/S1556-0864(25)00524-6/fulltext

Updated phase II efficacy and safety results of BNT327 ... 332P: Updated phase II efficacy and safety results of BNT327/PM8002 combined with paclitaxel as second-line (2L) therapy in small cell lung cancer (SCLC).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06449209

Study Details | NCT06449209 | Safety, Preliminary ... This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327. Detailed Description. In Cohort 1 of this study, two dose levels of BNT327 ...

5. oncologypipeline.com oncologypipeline.com/apexonco/world-lung-2025-pumitamig-confirms-its-small-cell-promise

World Lung 2025 – pumitamig confirms its small-cell promise The presentation also detailed median progression-free survival of 6.8 months, in line with the 6.9 months seen in the Chinese study. Data with ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02831-X/fulltext

1255MO A phase II safety and efficacy study of PM8002 ... PM8002/BNT327 in combination with chemotherapy showed encouraging antitumor activity and acceptable tolerability profile in EGFR-mutated NSCLC patients that ...