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BNT116 + Standard Therapy for Non-Small Cell Lung Cancer (LuCa-MERIT-1 Trial)
LuCa-MERIT-1 Trial Summary
This trialtests a new drug for advanced lung cancer, to determine its safety and best dose to use alone or with other treatments.
LuCa-MERIT-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLuCa-MERIT-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LuCa-MERIT-1 Trial Design
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Who is running the clinical trial?
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- I have NSCLC with PD-L1 expression ≥1% and cannot have chemotherapy as my first treatment.You have been on strong medications that weaken your immune system in the last 3 months before the trial.My lung cancer is at Stage III and cannot be removed by surgery.I have been treated with both a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.I am on low-dose steroids or only take them as hormone replacement.My lung cancer can be surgically removed and I am eligible for treatment before surgery.I am currently receiving treatment for non-small cell lung cancer.My lung cancer is confirmed by lab tests and can be measured.I have an autoimmune disease but it's controlled or is one of the exceptions listed.I have stable brain or spinal cancer and don't need steroids for it.I am HIV positive with a CD4+ count below 350 and have had AIDS-related infections.I am in good physical condition and can care for myself.My cancer has a specific mutation, but I can't receive the usual targeted therapy for it.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.My NSCLC worsened on PD-1/PD-L1 therapy or within 6 months after stopping it.My lung cancer was initially diagnosed as Stage II or III and considered operable.I can receive additional anti-PD-1 therapy without having stopped it before due to side effects.I have had treatments including PD-1/PD-L1 inhibitors, platinum-based chemotherapy, and another systemic therapy.I have had my spleen removed.
- Group 1: Cohort 1A - BNT116 monotherapy
- Group 2: Cohort 1B - BNT116 monotherapy
- Group 3: Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT])
- Group 4: Cohort 6 - BNT116 + cemiplimab + carboplatin + paclitaxel
- Group 5: Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients)
- Group 6: Cohort 3 - BNT116 + docetaxel
- Group 7: Cohort 4 - BNT116 + cemiplimab (frail patients)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants still being recruited for this experiment?
"According to the clinicaltrials.gov database, this medical trial is still actively searching for participants since it was initially posted on June 17th 2022 and recently updated on November 10th 2022."
What experiments have been previously undertaken to research the efficacy of combining Cohort 2 - BNT116 and cemiplimab?
"At present, Cohort 2 - BNT116 + cemiplimab has 374 live studies with 130 of them at Phase 3. While most are based in São Paulo and Rio Grande Do Norte respectively, there is a total 24109 sites conducting trials for the cohort around the world."
What is the maximum capacity of this research endeavor?
"Affirmative. According to clinicaltrials.gov, this study has been recruiting since June 17th 2022 and is actively searching for 80 individuals from 2 different healthcare facilities as of November 10th 2022."
Has the combination of BNT116 and cemiplimab obtained FDA clearance?
"Our team has rated Cohort 2 - BNT116 + cemiplimab with a score of 1 due to limited clinical data available that supports its safety and efficacy."
What is the traditional purpose of combining Cohort 2 - BNT116 and cemiplimab?
"Cohort 2 - BNT116 + cemiplimab is employed to treat metastatic cutaneous squamous cell carcinoma, but can also be beneficial for patients with head and soft tissue sarcoma (STS) or a ROS1 gene mutation."
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