BNT116 + Standard Therapy for Non-Small Cell Lung Cancer (LuCa-MERIT-1 Trial)
Recruiting in Palo Alto (17 mi)
+37 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: BioNTech SE
Stay on your current meds
No Placebo Group
Trial Summary
What is the purpose of this trial?This First-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with other therapies (cemiplimab, docetaxel, or a cytotoxic T-lymphocyte-associated protein 4 \[CTLA4\] antibody \[another investigational medicinal product\]) in patients with advanced or metastasized non-small cell lung cancer (NSCLC) and unresectable NSCLC after chemoradiotherapy (CRT). Furthermore, the trial aims to establish the safety and feasibility of BNT116 in combination with cemiplimab and chemotherapy (carboplatin+paclitaxel) as neo-adjuvant treatment in resectable NSCLC followed by surgery and adjuvant BNT116 + cemiplimab.
The trial will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but ongoing active systemic treatment against NSCLC is not allowed. If you are on systemic steroid medication, it must be reduced to a low dose before starting the trial.
What data supports the effectiveness of the drug BNT116 + Standard Therapy for Non-Small Cell Lung Cancer?
Recent studies have shown that adding immunotherapy to chemotherapy can improve survival in non-small cell lung cancer patients, suggesting that combining treatments like BNT116 with standard therapies might be effective.
12345Is the combination of BNT116 and standard therapy safe for humans?
The safety of BNT116 combined with standard therapy for non-small cell lung cancer isn't directly addressed in the provided research. However, similar treatments for this condition have shown a range of side effects, including skin, stomach, lung, and heart issues, which are important to monitor.
678910Eligibility Criteria
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not responded well to certain previous treatments. Specific groups include those with unresectable Stage III or metastatic Stage IV NSCLC, and some patients must have tried a PD-1/PD-L1 inhibitor therapy. Patients should be able to tolerate additional anti-PD-1 therapy and have an acceptable performance status.Inclusion Criteria
My lung cancer is at Stage III and cannot be removed by surgery.
My lung cancer can be surgically removed and I am eligible for treatment before surgery.
My lung cancer is at an advanced stage and cannot be surgically removed.
My lung cancer was deemed inoperable, and I've had chemoradiotherapy.
My cancer shows PD-L1 expression of 1% or more, and I will start cemiplimab at Cycle 3 in Cohort 1.
My cancer has a PD-L1 score of 50% or higher.
I can receive additional anti-PD-1 therapy without having stopped it before due to side effects.
Exclusion Criteria
I am currently receiving treatment for non-small cell lung cancer.
I am HIV positive with a CD4+ count below 350 and have had AIDS-related infections.
I have had my spleen removed.
Participant Groups
The trial tests BNT116 alone and in combination with cemiplimab or docetaxel for safety, tolerability, and preliminary effectiveness. It also explores BNT116 combined with chemotherapy as neo-adjuvant treatment before surgery followed by adjuvant BNT116 + cemiplimab in resectable cases.
8Treatment groups
Experimental Treatment
Group I: Cohort 7 - BNT116 + CTLA4 antibodyExperimental Treatment2 Interventions
Dose finding for the combination of BNT116 with CTLA4 antibody with dose escalation of the CTLA4 antibody
Group II: Cohort 6 - BNT116 + cemiplimab + carboplatin + paclitaxelExperimental Treatment4 Interventions
BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab
Group III: Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT])Experimental Treatment2 Interventions
Group IV: Cohort 4 - BNT116 + cemiplimab (frail patients)Experimental Treatment2 Interventions
Group V: Cohort 3 - BNT116 + docetaxelExperimental Treatment2 Interventions
Group VI: Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients)Experimental Treatment2 Interventions
Group VII: Cohort 1B - BNT116 monotherapyExperimental Treatment1 Intervention
Group VIII: Cohort 1A - BNT116 monotherapyExperimental Treatment1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, MD
NEXT VirginiaFairfax, VA
Norton Cancer InstituteLouisville, KY
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Who is running the clinical trial?
BioNTech SELead Sponsor
References
EGFR-Mutant NSCLC: Spotlight on Amivantamab. [2023]Data from three phase III trials-PAPILLON, MARIPOSA, and MARIPOSA-2-highlight amivantamab, an EGFR-MET bispecific antibody, as a potential contender as a standard treatment for EGFR-mutant non-small cell lung cancer. Amivantamab paired with chemotherapy is a superior first-line option for patients with exon 20-mutated disease. Beyond this subset, compared with standard osimertinib, the combination with or without lazertinib also boosted progression-free survival, albeit at the cost of added toxicity.
When immunotherapy meets surgery in non-small cell lung cancer. [2022]The results of the most recent Checkmate-816 trial in The New England Journal of Medicine using combination neoadjuvant immunotherapy with platinum-based chemotherapy in resectable non-small cell lung cancer demonstrate the effectiveness of neoadjuvant immunotherapy and provide further support that biology and personalized therapy represent the foundation of lung cancer treatment.
Maintenance therapy with pemetrexed and bevacizumab versus pemetrexed monotherapy after induction therapy with carboplatin, pemetrexed, and bevacizumab in patients with advanced non-squamous non small cell lung cancer. [2022]Single agent maintenance therapy is widely accepted for advanced non-squamous non small cell lung cancer (NSCLC). However, there is no consensus on the initial and maintenance phase regimens, and the clinical benefit of adding bevacizumab to cytotoxic drugs in the maintenance phase remains unclear.
Maintenance therapy in advanced non-small cell lung cancer: current status and future implications. [2010]Maintenance therapy for patients with advanced non-small cell lung cancer has been an area of intense investigation. Maintenance therapy has been divided into two broad categories: continuation maintenance when the chemotherapy or targeted agent was part of a defined number of cycles of combination therapy and in the absence of disease progression is continued as a single agent or switch maintenance when a third agent is initiated after four cycles of platinum-based double-agent chemotherapy in the absence of disease progression. Two monoclonal antibodies, cetuximab and bevacizumab, are used as continuation maintenance, but the incremental benefit of the maintenance therapy with these agents is undetermined. Phase III trials have not revealed an overall survival benefit for continuation maintenance chemotherapy, and this approach should be considered investigational. Phase III trials have demonstrated an improvement in overall survival with switch maintenance therapy with pemetrexed compared with placebo in patients with nonsquamous histology and erlotinib compared with placebo. Phase III trials have not revealed an improvement in quality of life with maintenance therapy. In the trials of maintenance therapy, 30 to 40% of patients enrolled in the observation or placebo arm did not receive second-line therapy, and among the patients who did receive second-line therapy, there was significant heterogeneity in the therapy. The development of maintenance therapy has raised issues about the role of treatment-free intervals in routine clinical care, trial design issues such as the optimal endpoint, the ethics of a placebo arm, and the implications of maintenance therapy for first-line trials.
Neoadjuvant immunotherapy in non-small-cell lung cancer: Times are changing-and fast. [2022]Recent data from a phase 3 trial have shown that the addition of immunotherapy to neoadjuvant chemotherapy improves event-free survival in patients with non-small-cell lung cancer (NSCLC). This is the first positive phase 3 trial in this setting, although several phase 3 trials are currently investigating the efficacy of neoadjuvant and adjuvant immunotherapy in resectable NSCLC.
Effectiveness of maintenance treatments for nonsmall cell lung cancer. [2020]Maintenance therapy for advanced nonsmall cell lung cancer has shown some clinical benefit for patients by improving progression-free survival and, to a lesser extent, overall survival. Two main strategies exist for maintenance therapy, ie, continuation and switch maintenance. Continuation maintenance involves the continued use of one of the induction drugs beyond 4-6 cycles of initial treatment. Switch maintenance utilizes a third agent initiated after first-line chemotherapy. Both cytotoxic agents and targeted agents have been studied. Switch maintenance therapy with pemetrexed in nonsquamous tumors and erlotinib appear to show the most clear clinical benefit. Continuation maintenance with bevacizumab has shown improvement in progression-free survival. Data concerning the role of cetuximab for maintenance is conflicting. Toxicity, quality of life, and cost are important confounding issues that need to be considered. Several ongoing Phase III trials are investigating strategies to improve on the current agents as well as testing promising new therapies.
Efficacy and Safety of EGFR Inhibitors in the Treatment of EGFRPositive NSCLC Patients: A Meta-Analysis. [2021]We compared the response rates, survival rates, and safety profile of epidermal growth factor receptor (EGFR) inhibitors with non-targeted chemotherapy and older EGFR inhibitors when used to treat advanced non-small cell lung cancer (NSCLC) patients with activating EGFR mutations.
Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. [2023]Targeted therapies have revolutionized the treatment for many patients with non-small cell lung cancer (NSCLC). Multiple new oral targeted therapies have been approved in the last decade; however, their overall efficacy may be reduced by poor adherence, treatment interruptions, or dose reductions due to adverse events. Most institutions lack standard monitoring protocols for toxicities from these targeted agents. This review describes important adverse events observed in clinical trials and reported by the U.S. Food and Drug Administration for both currently approved and upcoming promising therapies in the treatment of NSCLC. These agents cause a range of toxicities, including dermatologic, gastroenteric, pulmonary, and cardiac toxicities. This review proposes protocols for routine monitoring of these adverse events, both prior to initiation of therapy and while on treatment.
Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial. [2022]This trial aimed to investigate the treatment response, survival profiles and treatment-related adverse events (AEs) of apatinib plus docetaxel in advanced non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor (EGFR).
Drug-induced colitis on BRAF and MEK inhibitors for BRAF V600E-mutated non-small cell lung cancer: a case report. [2022]The combination of BRAF and MEK inhibitors has deeply changed the treatment of BRAF V600-mutant non-small cell lung cancer patients. These agents demonstrated high antitumor activity as well as safe and manageable toxicity profile. Hypertension, pyrexia and increased liver enzymes are the most common adverse events. Gastrointestinal toxicities are rare, and mainly consist of mild grade vomiting and diarrhea.