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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Kentucky
Baptist Health Hardin
RECRUITING
Elizabethtown
New York
NYU Langone - NYU Grossman School of Medicine
RECRUITING
New York
Texas
Texas Oncology, P.A.
ACTIVE_NOT_RECRUITING
Houston
Other Locations
Australia
Cancer Research SA (CRSA)
RECRUITING
Adelaide
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Gachon University Gil Medical Center
RECRUITING
Incheon
Gyeongsang National University Hospital (GNUH)
RECRUITING
Jinju
Samsung Medical Center
RECRUITING
Seoul
United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
RECRUITING
Cardiff
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Sarah Cannon Research Institute
RECRUITING
London
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2028-10
Participants
Target number of participants: 60
Treatments
Experimental: Part 1A - Pumitamig Dose 1 + docetaxel
Experimental: Part 1B - Pumitamig Dose 2 + docetaxel
Experimental: Part 2 - Selected doses of pumitamig + docetaxel
Dose expansion at the deemed safe dose
Sponsors
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov

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