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NCT06712316 · ClinicalTrials.gov registry record · Phase 2

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by BioNTech SE.

Recruiting
Registry status
Phase 2
Development phase
1,260
Enrollment target
20
Study locations

NCT06712316: Recruiting Phase 2 study of Non-Small Cell Lung Cancer, sponsored by BioNTech SE.

NCT06712316 is a Phase 2 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 1,260 participants, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06712316, a Phase 2 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by BioNTech SE.

RECRUITING
Registry status
Phase 2
Development phase
1,260 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Primary Outcome

For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen.

Conditions Studied

Non-Small Cell Lung Cancer

Interventions

  • DRUG Pembrolizumab
  • DRUG Carboplatin
  • DRUG Pemetrexed
  • DRUG Paclitaxel
  • DRUG Pumitamig

Study Locations (20)

Ohio

  • Gabrail Cancer Center Research - Canton
  • The Christ Hospital Cancer Center - Cincinnati
  • University of Cincinnati Medical Center - Cincinnati
  • The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion - Cleveland
  • Cleveland Clinic - Cleveland

Florida

  • Clermont Oncology Center - Clermont
  • Cleveland Clinic Florida - Martin North Hospital - Stuart
  • H. Lee Moffit Cancer center and research institute - Tampa
  • Cleveland Clinic Weston Hospital - Weston

Iowa

  • Physicians Clinic of Iowa - Cedar Rapids
  • Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics - Iowa City

New Jersey

  • Astera Cancer Care - East Brunswick
  • The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion - Paramus

Alaska

  • Alaska Oncology and Hematology, LLC - Anchorage

Kentucky

  • Baptist Health Hardin - Elizabethtown

Maryland

  • Frederick Health Hospital- James M Stockman Cancer Institute - Frederick

Missouri

  • SSM Health Cancer Care - St. Clare - Fenton

Trial Details

FieldValue
Enrollment Target 1,260 participants
Start Date 2025-01-07
Est. Completion 2030-03
Phase Phase 2
BioNTech SE

53 total trials

What NCT06712316 shows while recruiting

NCT06712316 is an interventional study that assigns participants to a tested intervention. Its 1,260 participants enrollment target places it among the larger protocols in the corpus, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% higher).

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT06712316 names 20 study sites across 11 states, led by Ohio, Florida, Iowa.

Frequently Asked Questions

What is clinical trial NCT06712316 about?

NCT06712316 is a clinical study titled "Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer". This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice...

What is the current status of trial NCT06712316?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,260 participants. The study started on 2025-01-07. Estimated completion is 2030-03.

What conditions does trial NCT06712316 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT06712316?

The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Pemetrexed (DRUG), Paclitaxel (DRUG), Pumitamig (DRUG).

Who is sponsoring clinical trial NCT06712316?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06712316 being conducted?

This trial has 20 study locations across Alaska, Florida, Iowa, Kentucky, Maryland. 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 NCT06712316's enrollment target sits among peer trials

1,260 16th of 454 higher than 439 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

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More recruiting context for NCT06712316

Source: ClinicalTrials.gov NCT06712316, the US trial registry maintained by the National Library of Medicine. NCT06712316 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.