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 (Sep 2026). This Phase 1/2 trial studies multiple treatments including BNT326 and Pumitamig for non-small cell lung cancer.
Treatment: BNT326 · Pumitamig — This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) 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). The main goals of this study are: 1. To find the best dose levels (DLs) for the combination of BNT326 and pumitamig. 2. To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are). 3. To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
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 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.
Required: EGFR exon 19 deletion
EGFR-sensitizing mutation Exon 21-L858R and 19del
Required: EGFR l858r
EGFR-sensitizing mutation Exon 21-L858R and 19del
Required: EGFR other than activating mutations
EGFR (other than activating mutations)
Required: ALK rearrangement
ALK
Required: ROS1 fusion
ROS proto-oncogene 1 (ROS1)
Required: MET mutation
gene encoding the hepatocyte growth factor receptor (MET)
Required: BRAF mutation
human gene that encodes a protein called B-Raf (BRAF)
Required: RET fusion
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 mutation
human epidermal growth factor receptor 2 (HER2)
Required: KRAS mutation
Kirsten rat sarcoma virus (KRAS)
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 payload
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 ... a topoisomerase I inhibitor payload (including topoisomerase I inhibitor-containing ADCs)
Lab requirements
Blood counts
adequate organ and bone marrow function within 7 days before randomization/enrollment as defined in the protocol
Kidney function
urine protein 2+ and 24-hour urine protein excretion 1 g excluded
Liver function
Child-Pugh class B or C cirrhosis excluded
Cardiac function
left ventricular ejection fraction <50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment excluded
adequate organ and bone marrow function within 7 days before randomization/enrollment as defined in the protocol; Child-Pugh class B or C cirrhosis excluded; urine protein 2+ and 24-hour urine protein excretion 1 g excluded; left ventricular ejection fraction <50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Hematology Oncology - Main Site · Los Angeles, California
- Stanford Cancer Institute · Stanford, California
- Yale University · New Haven, Connecticut
- Georgetown University - Lombardi Comprehensive Cancer Center · Washington D.C., District of Columbia
- Moffit Cancer Center · Tampa, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07111520 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER3-targeted therapy, topoisomerase I inhibitor payload disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify