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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
EU CTIS ID: 2024-518279-80-00
What this study is testing
To assess the safety and tolerability of pumitamig (BNT327) in combination with docetaxel (Part 1 and overall) in the trial population (participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy). To evaluate the efficacy of pumitamig (BNT327) with docetaxel in the trial population.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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. Participants must have received a minimum 2 cycles of immunotherapy in first-line treatment to be eligible to this trial. Only 1 prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If a 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. 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.
- Have at least one measurable lesion as the targeted lesion based on response evaluation criteria in solid tumors version 1.1 (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 (ECOG) status of 0 or 1.
- Adequate organ function.
- Participants must provide tumor tissue samples either from a freshly obtained biopsy or archival tissue obtained ≤18 months prior to enrollment: a) In these participants an optional on-treatment tumor biopsy is recommended, if medically feasible. b) For the Biomarker Cohort, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required. c) Despite best efforts, if tumor tissue specimen is not available, discussion with the sponsor’s Medical Monitor is required for enrollment.
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 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 7 days prior to the initiation of study treatment (except for docetaxel premedication).
- Have uncontrolled hypertension or poorly controlled diabetic conditions prior to 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 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.
See the full eligibility criteria
Who can join
- 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. Participants must have received a minimum 2 cycles of immunotherapy in first-line treatment to be eligible to this trial. Only 1 prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If a 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. 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.
- Have at least one measurable lesion as the targeted lesion based on response evaluation criteria in solid tumors version 1.1 (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 (ECOG) status of 0 or 1.
- Adequate organ function.
- Participants must provide tumor tissue samples either from a freshly obtained biopsy or archival tissue obtained ≤18 months prior to enrollment: a) In these participants an optional on-treatment tumor biopsy is recommended, if medically feasible. b) For the Biomarker Cohort, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required. c) Despite best efforts, if tumor tissue specimen is not available, discussion with the sponsor’s Medical Monitor is required for enrollment.
What rules you out
- 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 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 7 days prior to the initiation of study treatment (except for docetaxel premedication).
- Have uncontrolled hypertension or poorly controlled diabetic conditions prior to 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 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 significant risk of hemorrhage.
- Have superior vena cava syndrome or symptoms of spinal cord compression.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Korea, Republic of
- United Kingdom
- United States
- Australia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Korea, Republic of; United Kingdom; United States; Australia. 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 EU CTIS; the study team decides eligibility.