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Tests treatment safety and results for Non-small Cell Lung Cancer
Official title Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
ClinicalTrials.gov ID: NCT06841055
What this study is testing
What is Pumitamig?
Pumitamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as BNT327, PM8002.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care. Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior...
- Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study.
- Only one prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If participant had received adjuvant...
- Historical PD-L1 results must be available.
- Participants with actionable genetic alterations may be enrolled if they received locally approved and available targeted agent in combination with...
You likely can't join if
- Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see...
- Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific...
- 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 7...
- Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy.
- Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of study treatment.
See the full eligibility 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...
- Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study.
- Only one prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant...
- Historical PD-L1 results must be available.
- Participants with actionable genetic alterations may be enrolled if they 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 kept below 30% in the overall study 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...
- Participants must provide tumor tissue samples obtained ≤18 months prior to enrollment. For the additional cohort in Part 2, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required.
- Eastern cooperative oncology group performance status of 0 or 1.
- Adequate organ function as defined in the protocol. Key
- Have a known or suspected 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...
- 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 7 days prior to the initiation of study treatment (except for docetaxel...
- Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy.
- Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of study treatment.
- Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal...
- Participants with significant risk of hemorrhage as defined in the protocol.
- Have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tampa, Florida, United States
- Elizabethtown, Kentucky, United States
- New York, New York, United States
- Houston, Texas, United States
- Liverpool, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Austraila, Australia
- Hobart, Tasmania, Australia
- Nedlands, Western Australia, Australia
- Jinju, Gyeongsangnam-do, South Korea
- Cheongju-si, South Korea
- Incheon, South Korea
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
- Seville, Spain
- Valencia, Spain
- Adana, Turkey (Türkiye)
- Ankara, Turkey (Türkiye)
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tampa, Florida, United States; Elizabethtown, Kentucky, United States; New York, New York, United States; Houston, Texas, United States; Liverpool, New South Wales, Australia and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.