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Evaluating a new cancer vaccine for advanced non-small cell lung cancer

LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

PHASE1 · BioNTech SE · NCT05142189

This study is testing a new cancer vaccine to see if it can help people with advanced non-small cell lung cancer feel better, either on its own or with other treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorBioNTech SE (industry)
Drugs / interventionscemiplimab, osimertinib, chemotherapy, prednisone
Locations44 sites (Lexington, Kentucky and 43 other locations)
Trial IDNCT05142189 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety, tolerability, and preliminary efficacy of BNT116, a novel cancer vaccine, both as a standalone treatment and in combination with other approved and investigational therapies for patients with advanced non-small cell lung cancer (NSCLC). The trial includes multiple cohorts targeting different stages of NSCLC, allowing for a comprehensive evaluation of the vaccine's effectiveness in various treatment settings. Participants will receive treatment for up to 24 months, depending on their cohort, with the aim of establishing a safe dosage and understanding the vaccine's potential in combination therapies.

Who should consider this trial

Good fit: Ideal candidates for this trial are patients with unresectable or metastatic non-small cell lung cancer, including those with specific stages of the disease as outlined in the trial cohorts.

Not a fit: Patients with early-stage resectable non-small cell lung cancer may not benefit from this trial as it focuses on advanced disease stages.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced non-small cell lung cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promise with similar cancer vaccine approaches, indicating potential for success in this novel treatment strategy.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 do not have to present with measurable disease.

  1. 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
  2. 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.
  3. 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 \[PD-1\] / programmed death ligand 1 \[PD-L1\] therapy due to toxicity).
* Participants must have an Eastern Cooperative Oncology Group performance status (ECOG-PS) less than or equal to (\<=) 1, except for participants in Cohorts 1, 4, 5, 10 and 11 who are eligible with an ECOG-PS of 0-2.

Cohort-specific inclusion criteria:

Cohort 1:

* 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 platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor and/or another line of systemic therapy). Note: Participants newly enrolled in Cohort 1B under protocol v 5.0 and subsequent versions of the protocol must consent to mandatory blood sampling for peripheral blood mononuclear cells (PBMCs).
* Participants who are to start cemiplimab at Cycle 3 must present with PD-L1 expression of tumor proportion score (TPS) greater than or equal to (\>=) 1% in tumor cells (as determined locally).

Cohort 2:

* Participants must present with PD-L1 expression of tumor proportion score (TPS) \>= 50% in tumor cells (as determined locally prior to inclusion in this study).
* Participants must present with progressive disease either

  1. 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
  2. be refractory to ongoing adjuvant therapy/maintenance treatment after CRT with a PD-1/PD-L1 inhibitor that has been given for at least 3 months in monotherapy (i.e., after an initial combination therapy) before being enrolled into this study.

Cohort 3:

* 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 inhibitor).
* Participants must present with progressive disease.

Cohort 4:

* Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled if presenting with PD-L1 expression: TPS \>= 1% in tumor cells (as determined locally).

Cohort 5:

* Participants' NSCLC must have been considered unresectable due to participant's condition and/or tumor-related factors and the participants must have undergone chemoradiotherapy before entering the study.

Cohort 6:

* Participants' NSCLC must be considered technically and medically resectable.
* Participants must be considered eligible for neo-adjuvant treatment.

Cohort 7:

* 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 inhibitor). Note 1: Participants may have received prior therapy targeting CTLA-4, lymphocyte-activation gene 3 (LAG-3), T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif \[ITIM\] domain (TIGIT), VEGF or VEGF receptor (VEGFR) inhibitor as monotherapy or part of a combination therapy. Note 2: If the participants' prior therapies included a CTLA-4 inhibitor, the participant must be able to tolerate (additional) treatment with the CTLA-4 inhibitor.
* Participants must present with progressive disease at study enrollment.
* Participants must consent to mandatory blood sampling for PBMCs.

Cohorts 8 \& 9:

* 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 inhibitor).
* Participants must present with progressive disease at study enrollment.

Cohort 10:

* Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled.

Cohort 11:

* Participants' NSCLC must have been considered unresectable due to participants condition and/or tumor related factors and the participants must have undergone chemoradiotherapy before entering the study.

Cohort EGFR (will enroll only at selected sites in the US):

* Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.
* Participants must have ongoing treatment with osimertinib.

Cohort ALK/RET (will enroll only at selected sites in the US):

* 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 Exclusion Criteria:

* 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. Note: Participants with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included.
* Current evidence of new or growing brain or spinal metastases during screening. Participants with leptomeningeal disease are excluded. Participants with known brain or spinal metastases may be eligible for all Cohorts, except for Cohorts 5, 6 and 11, if they:
* 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 apart), AND
* do not require steroid therapy for the treatment of brain or spinal metastases within 14 days before the first dose of study treatment. Note: Spinal bone metastases (that is, of the vertebrae) are allowed, unless imminent fracture or cord compression is anticipated.
* Systemic immune suppression:
* 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. Note: Steroid medication given for supportive or prophylactic reasons during CRT for participants in Cohorts 5 and 11 needs to be tapered to \<= 5 mg/day prednisolone equivalent at latest on the day before the study treatment starts.
* 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 immunodeficiency syndrome (AIDS)-defining opportunistic infections.
* Prior splenectomy.
* History/risk of interstitial lung disease or low baseline lung function (baseline pulse oximetry of less than 92% oxygen saturation \[SpO2\] without additional oxygen).

NOTE: Other protocol defined Inclusion/Exclusion criteria apply to all or some participants depending on the cohort.

Where this trial is running

Lexington, Kentucky and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-Small Cell Lung Cancer, Cancer Vaccine, Combination with chemotherapy, Combination with other investigational agents, anti-B7-H3 antibody conjugated to topoisomerase I inhibitor, anti-HER3 antibody conjugated to topoisomerase I inhibitor, Immunotherapy, Antibody-drug conjugate

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.