BNT327 + Chemotherapy for Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: BioNTech SE
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This is a Phase III, multisite, randomized, double-blinded study to investigate BNT327 combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
What makes the drug BNT327 unique for treating small cell lung cancer?
The drug BNT327 is unique because it is being tested in combination with chemotherapy specifically for small cell lung cancer, which is a condition with limited long-term treatment success. While other treatments like belotecan and cisplatin are used, BNT327 may offer a novel approach, potentially improving outcomes by targeting the cancer differently.
23478What safety data exists for BNT327 + Chemotherapy for Small Cell Lung Cancer?
There is no specific safety data available for BNT327 in the provided research articles. However, other treatments for small cell lung cancer, like lurbinectedin, have shown an acceptable and manageable safety profile in patients with advanced solid tumors.
14569Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like systemic corticosteroids above a specific dose and some other therapies must not have been taken recently. It's best to discuss your current medications with the trial team.
Eligibility Criteria
This trial is for adults with untreated extensive-stage small-cell lung cancer (ES-SCLC). Participants must have confirmed ES-SCLC, be in good physical condition (ECOG status of 0 or 1), and have proper organ function. They should not have had previous systemic therapy for ES-SCLC, except those treated curatively for limited-stage SCLC who've been treatment-free for at least 6 months.Inclusion Criteria
My small cell lung cancer diagnosis is confirmed by lab tests.
I am fully active or have some restrictions but can still care for myself.
My lung cancer is at an advanced stage according to the AJCC 8th edition.
I haven't had systemic therapy for extensive-stage small cell lung cancer, but if I had treatment for limited-stage, it was over 6 months ago.
Participant Groups
The study compares BNT327 combined with chemotherapy drugs etoposide and carboplatin against the known drug Atezolizumab with the same chemo regimen. It's a Phase III trial where participants are randomly assigned to either group in a double-blinded manner, meaning neither they nor the researchers know who receives which treatment.
3Treatment groups
Experimental Treatment
Group I: Arm 3 - BNT327 Dose 2 + Etoposide + CarboplatinExperimental Treatment3 Interventions
Group II: Arm 2 - BNT327 Dose 1 + Etoposide + CarboplatinExperimental Treatment3 Interventions
Group III: Arm 1 - Atezolizumab + Etoposide + CarboplatinExperimental Treatment3 Interventions
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Clermont Oncology CenterClermont, FL
Millennium Research and Clinical Development, LLCHouston, TX
Hematology Oncology Associates of Fredericksburg, Inc.Fredericksburg, VA
Nebraska Hematology-Oncology (NHO)Lincoln, NE
More Trial Locations
Loading ...
Who is running the clinical trial?
BioNTech SELead Sponsor
Biotheus Inc.Industry Sponsor
References
Multicenter phase II study of brequinar sodium in patients with advanced lung cancer. [2019]A total of 53 patients with advanced lung cancer [non-small-cell (NSC), 21; small-cell (SC), 32] were treated with brequinar sodium. All of the NSC patients were chemotherapy-naive, but 31/32 (97%) SC patients had failed a multiagent chemotherapy program prior to study entry. Brequinar was given intravenously at a median weekly dose of 1200 mg/m2. The toxicity was moderate, with 19 patients (36%) experiencing grade 3 or 4 toxicity. Objective responses were observed in one NSC and two SC patients. We conclude that at this dose and on this schedule, brequinar does not have sufficient activity in patients with NSC or in patients with previously treated SC to warrant further evaluation. However, since responses were observed in previously treated SC lung-cancer patients, further evaluation in chemotherapy-naive patients may be warranted.
New agents in the treatment of small cell lung cancer. [2022]The treatment of small cell lung cancer (SCLC) has evolved significantly over the past 3 decades. Single-agent and combination chemotherapies given with radiotherapy have greatly improved response rates and median survival. Combination regimens such as cisplatin/etoposide, carboplatin/etoposide, ifosfamide/carboplatin/etoposide, cyclophosphamide/doxorubicin/vincristine, and etoposide/ifosfamide/cisplatin have all achieved good response rates. Improving long-term survival, however, has remained problematic. Treatment with biological response modifiers (interferons alpha and gamma) has not shown promise in this setting. New agents showing good preliminary single-agent activity in untreated SCLC include paclitaxel, vinorelbine, gemcitabine, topotecan, and teniposide. Results obtained with single-agent docetaxel and CPT-11 are thus far inconclusive. Studies evaluating response and survival rates of these new agents in combination with agents of known activity are underway.
Multicenter phase II trial of paclitaxel, cisplatin, and etoposide with concurrent radiation for limited-stage small-cell lung cancer. [2017]To investigate the feasibility, efficacy, and safety of adding paclitaxel to cisplatin/etoposide chemotherapy and concurrent thoracic radiotherapy (TRT) in treatment of limited-stage small-cell lung cancer (LD-SCLC).
Novel therapies for the treatment of small-cell lung cancer: a time for cautious optimism? [2018]Small-cell lung cancer accounts for up to one-fifth of all lung cancers diagnosed. While the response rates to chemotherapy are high, ultimately the majority of patients will relapse and die from their disease. Long-term outcomes are poor. A number of new agents and novel strategies for the treatment of small-cell lung cancer are under evaluation, and this review outlines the current most promising agents and pivotal trials. Oblimersen, an antisense oligonuclide to the oncogene bcl-2, has been safely combined with chemotherapy. The proteosome inhibitor bortezomib has not demonstrated single-agent activity in phase II trials but is now being evaluated with proapoptotic triggers. A number of anti-angiogenic strategies have been evaluated in small-cell lung cancer. The vascular endothelial growth factor (VEGF) antibody bevacizumab and a number of VEGF receptor tyrosine kinase inhibitors are in the early phases of clinical trials. Results from trials have not demonstrated any survival advantage with the addition of matrix metalloproteinase inhibitors. A phase III trial has reported improvements in median survival with the addition of thalidomide to chemotherapy, but toxicity has been problematic. Immunotherapy with p53 vaccines and BEC2 antibodies have shown some promise and require further evaluation to determine whether humoral responses can predict for response. Trials with the immunoconjugate BB-10901 and temirolimus are ongoing.
Second-line treatment of small-cell lung cancer. [2019]Approximately 45,000 new cases of small-cell lung cancer were diagnosed in 2005 in the United States. Although response to first-time therapy is up to 90%, the majority of patients will ultimately relapse. Therefore, active second-line therapy is needed for this patient population. The only second-line treatment for small-cell lung cancer approved by the US Food and Drug Administration is topotecan. Other agents have been investigated and have shown modest efficacy. These include vinorelbine, irinotecan, etoposide, paclitaxel, and gemcitabine. Novel "targeted therapies" have shown disappointing results in this disease. Much of the recent work has focused on investigating alternative dosing and scheduling of topotecan. Combination therapies have also been investigated, and some have been shown to increase activity over single agents, but toxicity and quality of life variables are imperative in the treatment of this patient population.
Small cell lung cancer. [2022]Small cell lung cancer accounts for approximately 15% of bronchogenic carcinomas. It is the cancer most commonly associated with various paraneoplastic syndromes, including the syndrome of inappropriate antidiuretic hormone secretion, paraneoplastic cerebellar degeneration, and Lambert-Eaton myasthenic syndrome. Because of the high propensity of small cell lung cancer to metastasize early, surgery has a limited role as primary therapy. Although the disease is highly sensitive to chemotherapy and radiation, cure is difficult to achieve. The combination of platinum and etoposide is the accepted standard chemotherapeutic regimen. It is also the accepted standard therapy in combination with thoracic radiotherapy (TRT) for limited-stage disease. Adding TRT increases absolute survival by approximately 5% over chemotherapy alone. Thoracic radiotherapy administered concurrently with chemotherapy is more efficacious than sequential therapy. Furthermore, the survival benefit is greater if TRT is given early rather than late in the course of chemotherapy. Regardless of disease stage, no relevant survival benefit results from increased chemotherapy dose intensity or dose density, altered mode of administration (eg, alternating or sequential administration) of various chemotherapeutic agents, or maintenance chemotherapy. Prophylactic cranial radiation prevents central nervous system recurrence and can improve survival. In Japan and some other Asian countries, the combination of irinotecan and cisplatin is the standard chemotherapeutic regimen. Clinical trials using thalidomide, gefitinib, imatinib, temsirolimus, and farnesyltransferase inhibitors have not shown clinical benefit. Other novel agents such as bevacizumab have shown promising early results and are being evaluated in larger trials.
Multicenter phase 2 study of belotecan, a new camptothecin analog, and cisplatin for chemotherapy-naive patients with extensive-disease small cell lung cancer. [2013]The objective of this study was to investigate the efficacy of belotecan, a new camptothecin analog, combined with cisplatin for the treatment of chemotherapy-naive patients with extensive-disease small cell lung cancer (ED SCLC).
Phase II study of combined belotecan and cisplatin as first-line chemotherapy in patients with extensive disease of small cell lung cancer. [2013]To determine the efficacy and safety of belotecan in combination with cisplatin as first-line chemotherapy for extensive disease of small cell lung cancer (ED SCLC).
Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. [2023]Label="BACKGROUND">Lurbinectedin was approved by FDA and other health regulatory agencies for treating adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Safety profile at approved dose (3.2 mg/m2 every 3 weeks) was acceptable and manageable in 105 adult SCLC patients from a phase II basket trial. This study analyses safety data from several solid tumours treated at the lurbinectedin-approved dose.