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NCT06562192 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
162
Enrollment target
20
Study locations

NCT06562192: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Novartis Pharmaceuticals.

NCT06562192 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 162 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06562192, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
162 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Primary Outcome

A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE (version 5.0) Grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.

Conditions Studied

Non-Small Cell Lung Cancer Colorectal Cancer Triple Negative Breast Cancer Pancreatic Ductal Adenocarcinoma HR+/HER2- Ductal and Lobular Breast Cancer

Interventions

  • DRUG [68Ga]Ga-NNS309
  • DRUG [177Lu]Lu-NNS309

Study Locations (20)

Other

  • Novartis Investigative Site - Brussels
  • Novartis Investigative Site - Bron
  • Novartis Investigative Site - Villejuif
  • Novartis Investigative Site - Essen
  • Novartis Investigative Site - München

California

  • University of California LA - Los Angeles
  • Stanford University Medical Center - Palo Alto

Michigan

  • BAMF Health - Grand Rapids
  • BAMF Health - Grand Rapids

Ontario

  • Novartis Investigative Site - Toronto
  • Novartis Investigative Site - Toronto

Quebec

  • Novartis Investigative Site - Montreal
  • Novartis Investigative Site - Montreal

Alabama

  • Uni of Alabama at Birmingham - Birmingham

Florida

  • Mayo Clinic Jacksonville - Jacksonville

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2024-10-15
Est. Completion 2031-01-16
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What NCT06562192 shows while recruiting

NCT06562192 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (75% lower).

The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which [68Ga]Ga-NNS309 is the first listed.

NCT06562192 names 20 study sites across 12 states, led by Other, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT06562192 about?

NCT06562192 is a clinical study titled "Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers". The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small ce...

What is the current status of trial NCT06562192?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 162 participants. The study started on 2024-10-15. Estimated completion is 2031-01-16.

What conditions does trial NCT06562192 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Pancreatic Ductal Adenocarcinoma, HR+/HER2- Ductal and Lobular Breast Cancer.

What interventions are being tested in trial NCT06562192?

The interventions under investigation include: [68Ga]Ga-NNS309 (DRUG), [177Lu]Lu-NNS309 (DRUG).

Who is sponsoring clinical trial NCT06562192?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06562192 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Michigan. 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 NCT06562192's enrollment target sits among peer trials

162 189th of 454 higher than 264 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 NCT06562192

Source: ClinicalTrials.gov NCT06562192, the US trial registry maintained by the National Library of Medicine. NCT06562192 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.