BNT327 + Docetaxel for Lung Cancer

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

Trial Summary

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.

What data supports the effectiveness of the drug BNT327 + Docetaxel for lung cancer?

Docetaxel, one of the components of the treatment, is known to be effective in treating advanced non-small-cell lung cancer, showing a 19% response rate and 28% 1-year survival in certain patients. It is well tolerated, especially in combination regimens, which suggests potential effectiveness when combined with BNT327. ^{1 2 3 4 5}

Is the combination of BNT327 and Docetaxel safe for humans?

The safety of docetaxel, a part of the treatment, has been studied in patients with advanced non-small cell lung cancer, showing a good safety profile with manageable side effects when used weekly at doses of 25-43 mg/m2. ^{3 6 7 8 9}

What makes the drug BNT327 + Docetaxel unique for lung cancer treatment?

The combination of BNT327 with Docetaxel is unique because it potentially offers a novel approach to treating lung cancer by combining a new agent (BNT327) with Docetaxel, which is already known for its effectiveness in non-small cell lung cancer. This combination may enhance the treatment's effectiveness or reduce side effects compared to using Docetaxel alone. ^{10 11 12 13 14}

What is the purpose of this trial?

This is a Phase II, multisite, open-label, single arm study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy. Part 1 is safety run-in with BNT327 (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of BNT327 plus docetaxel.

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Part 2 - Selected doses of BNT327 + docetaxel Experimental Treatment 2 Interventions

Dose expansion at the deemed safe dose

Group II: Part 1B - BNT327 Dose 2 + docetaxel Experimental Treatment 2 Interventions

Group III: Part 1A - BNT327 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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303). [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The role of weekly docetaxel in the treatment of advanced non-small-cell lung cancer. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Japanese experience with second-line chemotherapy with low-dose (60 mg/M2) docetaxel in patients with advanced non-small-cell lung cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Phase I/II study of docetaxel and S-1 in patients with previously treated non-small cell lung cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Alpha-1-acid glycoprotein as an independent predictor for treatment effects and a prognostic factor of survival in patients with non-small cell lung cancer treated with docetaxel. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Phase II study of S-1, a novel oral fluoropyrimidine, and biweekly administration of docetaxel for previously treated advanced non-small-cell lung cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A phase II study of weekly docetaxel plus capecitabine for patients with advanced nonsmall cell lung carcinoma. [2018]

8. Greece pubmed.ncbi.nlm.nih.gov

Weekly docetaxel as second-line chemotherapy in advanced non-small cell lung cancer: phase II trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Weekly docetaxel as second-line therapy in non-small cell lung cancer: a phase II study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Epirubicin, cisplatin and docetaxel combination therapy for metastatic gastric cancer. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Docetaxel in non-small cell lung cancer: a review. [2019]

12. United States 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. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Phase II study of docetaxel and cisplatin in advanced non-small-cell lung cancer. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

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