Trial studying safety and effects for Non-Small Cell Lung Cancer
Official title Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05142189
What this study is testing
What is BNT116?
BNT116 is an investigational biological medicine being studied as a potential treatment for non-small cell lung cancer.
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 study aims to find a safe dose of BNT116 and check if it works when used alone or with other cancer drugs.
- Who it's for
- People with non-small cell lung cancer that has spread or cannot be removed by surgery.
- What's involved
- Participants will receive BNT116, possibly with other approved or experimental cancer drugs, and undergo regular medical tests.
- Time commitment
- The study involves multiple groups with different treatment plans, but the total duration is not specified in the text.
- Phase 1: an early, usually small safety study
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
- Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1.
- Participants must present with unresectable Stage III or metastatic Stage IV NSCLC by American Joint Commission on Cancer (AJCC) Cancer Staging...
- Participants in Cohorts 5 and 11 must present with unresectable Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition before receiving...
- Participants in Cohort 6 with the initial diagnosis of resectable Stage II and Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition.
- Participants in Cohorts 2, 4, 5, 6, 10 and 11 must be able to tolerate (additional) anti-PD-1 therapy (i.e., did not permanently discontinue...
You likely can't join if
- Ongoing active systemic treatment against NSCLC.
- Presence of a driver mutation for which approved target therapies are available except if the participant is not a candidate for the respective...
- Ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive...
- had radiotherapy or another appropriate therapy for the brain or spinal metastases, AND
- have no neurological symptoms that can be attributed to the current brain lesions, AND
- have stable brain or spinal disease on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the...
See the full eligibility criteria
- Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 as well as in Cohorts EGFR and ALK/RET do not have to present with measurable...
- Participants must present with unresectable Stage III or metastatic Stage IV NSCLC by American Joint Commission on Cancer (AJCC) Cancer Staging Manual, Eighth Edition. EXCEPT
- Participants in Cohorts 5 and 11 must present with unresectable Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition before receiving pre-study chemoradiotherapy.
- Participants in Cohort 6 with the initial diagnosis of resectable Stage II and Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition.
- Participants in Cohorts 2, 4, 5, 6, 10 and 11 must be able to tolerate (additional) anti-PD-1 therapy (i.e., did not permanently discontinue anti-programmed death protein 1 [PD-1] / PD-L1] therapy due to toxicity).
- Participants' prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen as well as one other line of systemic therapy (except if a participant is not candidate for a...
- Participants must present with PD-L1 expression of TPS \>= 50% in tumor cells (as determined locally prior to inclusion in this study).
- Participants must present with progressive disease either
- in the advanced or metastasized stage of NSCLC: while on a PD-1/PD-L1 inhibitor therapy or within 6 months of termination of this treatment as first-line treatment. Or
- Participants' prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1...
- Participants' NSCLC must be considered technically and medically resectable.
- Participants' prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and/or PD-1/PD-L1...
- Participants must present with progressive disease at study enrollment.
- Participants' prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and/or PD-1/PD-L1...
- Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.
- Participants' NSCLC must have ALK rearrangement or RET rearrangement.
- Participants must have ongoing treatment with a standard of care ALK TKI or RET TKI. Key
- Ongoing active systemic treatment against NSCLC.
- Presence of a driver mutation for which approved target therapies are available except if the participant is not a candidate for the respective targeted therapy. EXCEPT participants in Cohort EGFR and Cohort ALK/RET.
- Ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events.
- had radiotherapy or another appropriate therapy for the brain or spinal metastases, AND
- have no neurological symptoms that can be attributed to the current brain lesions, AND
- have stable brain or spinal disease on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent (confirmed by stable lesions on two scans at least 4 weeks...
- do not require steroid therapy for the treatment of brain or spinal metastases within 14 days before the first dose of study treatment.
- Current use of chronic systemic steroid medication (\<= 5 mg/day prednisolone equivalent is allowed); participants using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible.
- Other clinically relevant systemic immune suppression within the last 3 months before study enrollment.
- Known history of seropositivity for human immunodeficiency virus (HIV) with cluster of differentiation 4 (CD4)+ T-cell (CD4+) counts less than (\<) 350 cells/microlitre (mcL) and with a history of acquired...
- Prior splenectomy.
- History/risk of interstitial lung disease or low baseline lung function (baseline pulse oximetry of less than 92% oxygen saturation without additional oxygen).
The study team makes the final eligibility decision.
Where it is enrolling
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Randwick, New South Wales, Australia
- Sydney, New South Wales, Australia
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Cologne, Germany
- Frankfurt, Germany
- Hamburg, Germany
- Mainz, Germany
- Budapest, Hungary
- Gyöngyös, Hungary
- Gdansk, Poland
- Olsztyn, Poland
- Poznan, Poland
- Badalona, Spain
+ 14 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, but 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?
This study is enrolling now at Lexington, Kentucky, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States; Columbus, Ohio, United States; Houston, Texas, United States; Fairfax, Virginia, United States and 28 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.