RECRUITING

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy

Conditions

Non-small Cell Lung Cancer Second-line treatment Immunotherapy Combination with other investigational agents Bispecific antibody Vascular endothelial growth factor (VEGF) A Programmed death-ligand 1 (PD-L1)Combination with chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 pumitamig (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 pumitamig plus docetaxel.

Official Title

A Phase II, Multisite, Open-label, Single Arm Trial of BNT327 in Combination With Docetaxel in Second-line Stage IV Non-small Cell Lung Cancer (NSCLC) Following Chemoimmunotherapy

Quick Facts

Study Start:2025-03-03

Study Completion:2028-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06841055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 8th edition. * Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this trial. * Only one prior line of immunotherapy containing regimen is allowed in advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months. * Historical PD-L1 results must be available. * Patients with actionable genetic alterations are allowed to be enrolled if patients received locally approved and available targeted agent in combination with immunotherapy in first-line advanced/metastatic setting. * Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be capped under 30% in the overall trial population. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the Screening Visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator. * Eastern cooperative oncology group performance status of 0 or 1. * Adequate organ function.	* Known hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label). * Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents. * Have received more than one prior lines of therapies in advanced/metastatic setting. * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. * Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment. * Have a serious non-healing wound, ulcer, or bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Participants with evidence of major coagulation disorders or other significant risks of hemorrhage. * Have superior vena cava syndrome or symptoms of spinal cord compression

Inclusion Criteria

Exclusion Criteria

* Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 8th edition.
* Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this trial.
* Only one prior line of immunotherapy containing regimen is allowed in advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months.
* Historical PD-L1 results must be available.
* Patients with actionable genetic alterations are allowed to be enrolled if patients received locally approved and available targeted agent in combination with immunotherapy in first-line advanced/metastatic setting.
* Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be capped under 30% in the overall trial population.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the Screening Visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator.
* Eastern cooperative oncology group performance status of 0 or 1.
* Adequate organ function.

* Known hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label).
* Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents.
* Have received more than one prior lines of therapies in advanced/metastatic setting.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* Have a serious non-healing wound, ulcer, or bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
* Participants with evidence of major coagulation disorders or other significant risks of hemorrhage.
* Have superior vena cava syndrome or symptoms of spinal cord compression

Contacts and Locations

Study Contact

BioNTech clinical trials patient information

CONTACT

+49 6131 9084

patients@biontech.de

Principal Investigator

BioNTech Responsible Person

STUDY_DIRECTOR

BioNTech SE

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Baptist Health Hardin

Elizabethtown, Kentucky, 42701

United States

NYU Langone - NYU Grossman School of Medicine

New York, New York, 10016

United States

Texas Oncology, P.A.

Houston, Texas, 77090

United States

Collaborators and Investigators

Sponsor: BioNTech SE

BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03

Study Completion Date2028-10

Study Record Updates

Study Start Date2025-03-03

Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

Second-line treatment
Immunotherapy
Combination with other investigational agents
Bispecific antibody
Vascular endothelial growth factor (VEGF) A
Programmed death-ligand 1 (PD-L1)
Combination with chemotherapy

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer