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Tests treatment safety and results for Non-small Cell Lung Cancer
Official title Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
ClinicalTrials.gov ID: NCT06712316
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.
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 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or...
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation...
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate organ function. Key
You likely can't join if
- Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant/adjuvant or locally advanced/metastatic setting.
- Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7...
- Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
See the full eligibility criteria
- Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre...
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, treatment procedures, etc.) are generally not considered as target...
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate organ function. Key
- Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant/adjuvant or locally advanced/metastatic setting.
- Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody
- 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. Note: local, intranasal...
- 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...
- Participants with significant risk of hemorrhage (per investigator clinical judgment).
- Have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Concord, California, United States
- La Jolla, California, United States
- Clermont, Florida, United States
- Orange City, Florida, United States
- Stuart, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Fort Wayne, Indiana, United States
- Cedar Rapids, Iowa, United States
- Iowa City, Iowa, United States
- Elizabethtown, Kentucky, United States
- Frederick, Maryland, United States
- Columbia, Missouri, United States
- Fenton, Missouri, United States
- Hastings, Nebraska, United States
- East Brunswick, New Jersey, United States
- Florham Park, New Jersey, United States
- Paramus, New Jersey, United States
+ 198 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; Anchorage, Alaska, United States; Concord, California, United States; La Jolla, California, United States; Clermont, Florida, United States; Orange City, Florida, United States and 212 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.