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NCT06713564
A Phase 1b, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
Phase 1 trial testing LS301-IT in Lung Cancers in 24 participants. Completed in 6 May 2026.
6 May 2026
Quick facts
| Lead sponsor | Integro Theranostics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 7 November 2024 |
| Primary completion | 6 May 2026 |
| Estimated completion | 6 May 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- LS301-IT — full drug profile →
Conditions studied
- Lung Cancers — all drugs for Lung Cancers →
Sponsor
Integro Theranostics — full company profile →
Who can join
18 and older, any sex, with Lung Cancers. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Patients with Dose Limiting Toxicities
Time frame: 2 to 7 days after dosing
Dose Limiting Toxicity - Any CTCAE Grade 2, 3, 4, or 5 AE (any treatment emergent sign or symptom) at least possibly related to IMP will be considered a DLT, as well as any other AE deemed clinically relevant by the SRC. -
Number of Patients that discontinue the study or have their surgery cancelled due to toxicity
Time frame: From start of dosing to time of surgery
Treatment discontinuation and/or surgery cancellation due to toxicity (hypersensitivity reaction to LS301-IT)
Sponsor's own description
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06713564
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06713564 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Integro Theranostics
- Last refreshed: 18 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06713564.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing