Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07111520 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 420
- Enrollment target
- 2
- Study locations
NCT07111520: Recruiting Phase 1 study of Non-Small Cell Lung Cancer, sponsored by BioNTech SE.
NCT07111520 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 420 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (35% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07111520, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 420 participants
- Enrollment target
- 2
- Study locations
Study Summary
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).
Primary Outcome
During the DLT evaluation period by dose level
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG BNT327
- DRUG BNT326
- DRUG SoC
Study Locations (2)
Virginia
- NEXT Virginia - Fairfax
Other
- Institute of Oncology, ARENSIA Exploratory Medicine - Chisinau
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2025-09-22 |
| Est. Completion | 2030-01 |
| Phase | Phase 1 |
What NCT07111520 shows while recruiting
NCT07111520 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT07111520 reports a single indexed study location in Virginia, Other.
Frequently Asked Questions
What is clinical trial NCT07111520 about?
NCT07111520 is a clinical study titled "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)". 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 pa...
What is the current status of trial NCT07111520?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 420 participants. The study started on 2025-09-22. Estimated completion is 2030-01.
What conditions does trial NCT07111520 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT07111520?
The interventions under investigation include: Pembrolizumab (DRUG), BNT327 (DRUG), BNT326 (DRUG), SoC (DRUG).
Who is sponsoring clinical trial NCT07111520?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07111520 being conducted?
This trial has 2 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07111520's enrollment target sits among peer trials
420 92nd of 454 higher than 360 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
RECRUITING · Phase 1
-
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
RECRUITING · Phase 1
-
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 1
-
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
RECRUITING · Phase 1
-
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01790152 · 420 participants
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
- NCT02701244 · 420 participants
A Registry Study of Breast Microseed Treatment
- NCT02966665 · 420 participants · Phase 1
: Vascular Function in Health and Disease
- NCT04149743 · 420 participants · NA
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI