OncoMatch/Clinical Trials/NCT07111520
A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
Is NCT07111520 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including BNT326 and BNT327 for non-small cell lung cancer.
Treatment: BNT326 · BNT327 · Pembrolizumab · SoC — This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR activating mutation
EGFR-sensitizing mutation Exon 21-L858R and 19del
Required: EGFR mutation (other than activating mutations)
EGFR (other than activating mutations)
Required: ALK rearrangement
ALK gene rearrangements
Required: ROS1 fusion
ROS proto-oncogene 1 (ROS1)
Required: MET alteration
gene encoding the hepatocyte growth factor receptor (MET)
Required: BRAF alteration
human gene that encodes a protein called B-Raf (BRAF)
Required: RET alteration
rearranged during transfection (RET)
Required: NTRK1 fusion
neurotrophic tropomyosin-receptor kinase (NTRK)
Required: NTRK2 fusion
neurotrophic tropomyosin-receptor kinase (NTRK)
Required: NTRK3 fusion
neurotrophic tropomyosin-receptor kinase (NTRK)
Required: HER2 (ERBB2) alteration
human epidermal growth factor receptor 2 (HER2)
Required: KRAS alteration
Kirsten rat sarcoma virus (KRAS)
Required: EGFR wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: ALK wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: ROS1 wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: MET wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: BRAF wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: RET wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: NTRK1 wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: NTRK2 wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: NTRK3 wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: HER2 (ERBB2) wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Required: KRAS wild-type
Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.
Disease stage
Metastatic disease required
Have measurable disease defined by RECIST v1.1. advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HER3-targeted therapy
Exception: For Part 2a Cohort A, prior exposure to agents targeting HER3 or topoisomerase I inhibitor payload may be allowed on a case-by-case basis after discussion with and approval by the sponsor.
Had disease progression on or were intolerant to prior treatment with an agent targeting HER3 (including antibody, ADC, cell therapy, and other drugs)
Cannot have received: topoisomerase I inhibitor
Exception: For Part 2a Cohort A, prior exposure to agents targeting HER3 or topoisomerase I inhibitor payload may be allowed on a case-by-case basis after discussion with and approval by the sponsor.
Had disease progression on or were intolerant to prior treatment with an agent...with a topoisomerase I inhibitor payload (including topoisomerase I inhibitor-containing ADCs)
Lab requirements
Blood counts
Have adequate organ and bone marrow function within 7 days before randomization/enrollment
Kidney function
Have urine protein ≥2+ and 24-hour urine protein excretion ≥1 g
Liver function
Child-Pugh class B or C cirrhosis excluded
Cardiac function
Have left ventricular ejection fraction <50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment
Have adequate organ and bone marrow function within 7 days before randomization/enrollment. Child-Pugh class B or C cirrhosis excluded. Have left ventricular ejection fraction <50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment. Have urine protein ≥2+ and 24-hour urine protein excretion ≥1 g.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NEXT Virginia · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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