Lung CancerPhase 2NCT05048082
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies
A Phase 2 study testing pegsitacianine and Tumor resection surgery in people with Lung Cancer, run by OncoNano Medicine, Inc. at 2 sites in United States.
Trial summary
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- pegsitacianine and Tumor resection surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2022to 31 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging
Who cannot join
- Known hypersensitivity or allergy to indocyanine green (ICG), polymethylmethacrylate (PMMA; found in dental and bone cements) or polyethylene glycol (PEG)
- Tumor locations the surgeon deems unfeasible to image intraoperatively
- Excessive and/or generalized disease deemed inoperable by the surgeon
- Life expectancy less than 12 weeks
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 2, Single-Dose, Open-Label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies, in Patients Undergoing Routine Surgery
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
Read the detailed description
This single-arm trial will enroll patients with biopsy confirmed or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging. A total of up to 40 patients will be enrolled in this trial. The sponsor reserves the right to perform an interim analysis following early enrollment (i.e., n ≤ 10 subjects) to determine the feasibility and benefit of pegsitacianine as an adjunct to standard of care surgical resection of lung malignancies.
The surgeon will begin by attempting to perform their SOC tumor resection. If the tumor is unable to be located under standard white light conditions, an appropriate FDA-cleared near-infrared imaging device may be used to aid in the location of the primary tumor. Localization of the primary tumor, when unable to be located using white light imaging, in conjunction with pathology confirmed presence of disease will be considered a clinically significant event. Following any standard of care procedures conducted under white light only, the near infrared camera will be used to evaluate areas of residual fluorescence that may be resected if suscpicious for metastatic spread or residual margins. The fluorescence status of each specimen will then be correlated to the final pathology for each, and performance metrics of pegsitacianine will be tabulated.
- Conditions
- Lung Cancer
- Being tested
- pegsitacianine, Tumor resection surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegsitacianineDrug
Also called ONM-100
An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
Tumor resection surgeryProcedure or surgery
Standard of care surgical removal of cancerous lung lesion
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence imaging with pegsitacianine | Experimental | Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery. Receives: Drug: pegsitacianine; Procedure: Tumor resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE)
Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies.
Measured: 1 day
Secondary outcomes (4)
Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
# of true positive specimens divided by the (#of true positive specimens + # of false negative specimens)
Measured: 7 days
Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens)
Measured: 7 days
Negative Predictive Value of Pegsitacianine
# of True negative specimens divided by the (# of true negative specimens + # of false negative specimens)
Measured: 7 days
Positive Predictive Value of Pegsitacianine
# of true positive specimens divided by the (# of true positive + # of false positive specimens)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start13 Apr 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An interventional, open-label, single arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine administered intravenously prior to standard of care (SOC) surgery.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoNano Medicine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunil Singhal, MD, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048082
- Sponsor's protocol ID
- ON-1005
- Status last verified
- Nov 2024
- First submitted
- 7 Sep 2021
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bou-Samra P, Singhal S. Precision Oncology in Lung Cancer Surgery. Hematol Oncol Clin North Am. 2026 Oct;40(5):797-806. doi: 10.1016/j.hoc.2026.05.018.
PubMed 42686329
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Dose, Open-Label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies, in Patients Undergoing Routine Surgery
- ClinicalTrials.gov ID
- NCT05048082
- Acronym / sponsor ID
- ON-1005
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- OncoNano Medicine, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
Detailed description
This single-arm trial will enroll patients with biopsy confirmed or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging. A total of up to 40 patients will be enrolled in this trial. The sponsor reserves the right to perform an interim analysis following early enrollment (i.e., n ≤ 10 subjects) to determine the feasibility and benefit of pegsitacianine as an adjunct to standard of care surgical resection of lung malignancies.
The surgeon will begin by attempting to perform their SOC tumor resection. If the tumor is unable to be located under standard white light conditions, an appropriate FDA-cleared near-infrared imaging device may be used to aid in the location of the primary tumor. Localization of the primary tumor, when unable to be located using white light imaging, in conjunction with pathology confirmed presence of disease will be considered a clinically significant event. Following any standard of care procedures conducted under white light only, the near infrared camera will be used to evaluate areas of residual fluorescence that may be resected if suscpicious for metastatic spread or residual margins. The fluorescence status of each specimen will then be correlated to the final pathology for each, and performance metrics of pegsitacianine will be tabulated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An interventional, open-label, single arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine administered intravenously prior to standard of care (SOC) surgery.
| Arm | Type | Receives |
|---|---|---|
| Fluorescence imaging with pegsitacianine | Experimental | Drug: pegsitacianine, Procedure: Tumor resection surgeryPegsitacianine 1 mg/ml infused 24-72 hours prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging
Key exclusion criteria (4 listed)
- Known hypersensitivity or allergy to indocyanine green (ICG), polymethylmethacrylate (PMMA; found in dental and bone cements) or polyethylene glycol (PEG)
- Tumor locations the surgeon deems unfeasible to image intraoperatively
- Excessive and/or generalized disease deemed inoperable by the surgeon
- Life expectancy less than 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegsitacianineAlso: ONM-100An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG). | Drug | Fluorescence imaging with pegsitacianine |
| Tumor resection surgeryStandard of care surgical removal of cancerous lung lesion | Procedure or surgery | Fluorescence imaging with pegsitacianine |
Primary outcome
Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE)
Time frame: 1 day
Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies.
4 secondary outcomes
Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
Time frame: 7 days
Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
Time frame: 7 days
Negative Predictive Value of Pegsitacianine
Time frame: 7 days
Positive Predictive Value of Pegsitacianine
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42686329Bou-Samra P, Singhal S. Precision Oncology in Lung Cancer Surgery. Hematol Oncol Clin North Am. 2026 Oct;40(5):797-806. doi: 10.1016/j.hoc.2026.05.018.
- A Phase 2 Multicenter Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer with a pH-Activatable NanoprobeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Singhal, MD principal investigator
Penn Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegsitacianine and Tumor resection surgery in people with Lung Cancer, run by OncoNano Medicine, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05048082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.