Lung Cancer (Locally Advanced or Metastatic)Phase 1NCT07772895
Pemefolacianine for IMI of Lung Cancer
A Phase 1 study testing Pemefolacianine Cohort 1 in Part A and Pemefolacianin Cohort 2 in Part B in people with Lung Cancer (Locally Advanced or Metastatic), run by Sunil Singhal at 1 site in United States.
Trial summary
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Locally Advanced or Metastatic)
- What is being tested?
- Pemefolacianine Cohort 1 in Part A and Pemefolacianin Cohort 2 in Part B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 11 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Male or Female subjects greater than 18 years of age inclusive, at the time of signing the informed consent.
- Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
- Are scheduled to undergo surgical thoracoscopy or open surgery (thoracotomy) and resection of the lung.
- If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to Pemefolacianine for Injection administration, as well as using a medically acceptable form of contraception
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Who cannot join
- Contraindications for surgery or any medical condition that in the opinion of the investigator could significantly jeopardize the safety of the subject
- No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery (e.g., Cytalux)
- History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.
- Known sensitivity to fluorescent light
- Patients with impaired renal function as defined by a creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)
- History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) > 470 ms
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- History of radiation therapy to the chest
- Received a systemic investigational drug of any kind for any indication within 4 weeks or 5 half-lives prior to administration of Pemefolacianine for Injection and/or the patient has received Pemefolacianine for Injection previously
- Total bilirubin level >1.5 times upper limit of normal at screening
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 times the upper limit of normal (ULN) at screening
- The patient is pregnant, breast feeding, or plans to become pregnant within 6 months of the administration of Pemefolacianine for Injection or has a positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Azra Din, MPH, 215-615-7980, azra.din@pennmedicine.upenn.edu
About this study
Official title: A Phase IB, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of Pemefolacianine for Intraoperative Molecular Imaging of Lung Cancer
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
- Being tested
- Pemefolacianine Cohort 1 in Part A, Pemefolacianin Cohort 2 in Part B
- Keywords
- Lung Nodule, Lung cancer
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemefolacianine Cohort 1 in Part ADrug
Also called Pemefolacianine
Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 1 patients will receive dose of 0.02 mg/kg
Pemefolacianin Cohort 2 in Part BDrug
Also called Pemefolacianine
Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 2 patients will receive dose of 0.04 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Pemefolacianine Cohort 1 | Experimental | The dose of Pemefolacianine for Injection planned to be administered to the first cohort of patients is 0.02 mg/kg. Receives: Drug: Pemefolacianine Cohort 1 in Part A |
| Pemefolacianine Cohort 2 | Experimental | The patients in second cohort were planned to receive dose Pemefolacianine for Injection at 0.04 mg/kg. Receives: Drug: Pemefolacianin Cohort 2 in Part B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety of Pemefolacianine for Injection, as assessed by the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant changes in laboratory values, vital signs, physical examinations, and electrocardiograms (ECGs) from baseline through the end of the study.
Measured: Day 1 through Day 30
Secondary outcomes (1)
Signal-to-Background Ratio in Intraoperative Tissue Images
Surgeon intraoperative semi-quantitative fluorescence assessments will be collected. Video images will be analyzed for fluorescence signal (eg, mean fluorescence intensity) and ratios (eg, signal-to-background, tumor/non-tumor) will be determined in various images and recorded. Descriptive statistics will be obtained and compared with histopathology and the surgeon's assessment of fluorescence in each tissue type.
Measured: Day 2 surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start11 Mar 2026
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Locally Advanced or Metastatic)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunil Singhal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sunil Singhal, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772895
- Sponsor's protocol ID
- UPCC 28525
- Status last verified
- Mar 2026
- First submitted
- 21 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of Pemefolacianine for Intraoperative Molecular Imaging of Lung Cancer
- ClinicalTrials.gov ID
- NCT07772895
- Acronym / sponsor ID
- UPCC 28525
- Keywords
- Lung Nodule, Lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sunil SinghalUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 11 Mar 2027 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemefolacianine Cohort 1 | Experimental | Drug: Pemefolacianine Cohort 1 in Part AThe dose of Pemefolacianine for Injection planned to be administered to the first cohort of patients is 0.02 mg/kg. |
| Pemefolacianine Cohort 2 | Experimental | Drug: Pemefolacianin Cohort 2 in Part BThe patients in second cohort were planned to receive dose Pemefolacianine for Injection at 0.04 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female subjects greater than 18 years of age inclusive, at the time of signing the informed consent.
- Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
- Are scheduled to undergo surgical thoracoscopy or open surgery (thoracotomy) and resection of the lung.
- If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to Pemefolacianine for Injection administration, as well as using a medically acceptable form of contraception
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Key exclusion criteria (11 listed)
- Contraindications for surgery or any medical condition that in the opinion of the investigator could significantly jeopardize the safety of the subject
- No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery (e.g., Cytalux)
- History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.
- Known sensitivity to fluorescent light
- Patients with impaired renal function as defined by a creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)
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 |
|---|---|---|
| Pemefolacianine Cohort 1 in Part AAlso: PemefolacianineEnrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 1 patients will receive dose of 0.02 mg/kg | Drug | Pemefolacianine Cohort 1 |
| Pemefolacianin Cohort 2 in Part BAlso: PemefolacianineEnrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 2 patients will receive dose of 0.04 mg/kg | Drug | Pemefolacianine Cohort 2 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 through Day 30
Safety of Pemefolacianine for Injection, as assessed by the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant changes in laboratory values, vital signs, physical examinations, and electrocardiograms (ECGs) from baseline through the end of the study.
1 secondary outcome
Signal-to-Background Ratio in Intraoperative Tissue Images
Time frame: Day 2 surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemefolacianine Cohort 1 in Part A and Pemefolacianin Cohort 2 in Part B in people with Lung Cancer (Locally Advanced or Metastatic), run by Sunil Singhal at 1 site 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: Day 1 through Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.