Cancer in the LungPhase 4NCT07469202
CYTALUX Dose Extension Study
A Phase 4 study testing CYTALUX (pafolacianine) injection in people with Cancer in the Lung and Ovarian Cancer, run by On Target Laboratories, LLC.
Trial summary
The goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer in the Lung, Ovarian Cancer
- What is being tested?
- CYTALUX (pafolacianine) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 28 Feb 2027
- Phase
- Phase 4
- 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 and female patients 18 years of age and older
- Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer
- Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking/cytoreduction
- Willingness of research participant or legal guardian/representative to give written informed consent
Who cannot join
- History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
- History of allergy to any of the components of Cytalux™ (pafolacianine)
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
- Known sensitivity to fluorescent light
- Impaired renal function defined as eGFR< 50 mL/min/1.73m2
- Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >2x ULN for total bilirubin excluding those patients with Gilbert's syndrome
- Pregnant and/or lactating women
- Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer
The goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. This study is being done in adult patients undergoing surgery for malignant or non-malignant lung lesions or for confirmed ovarian cancer.
Read the detailed description
This is a prospective, multicenter, open-label, non-inferiority study designed to evaluate the clinical adequacy of intraoperative tumor fluorescence following administration of Cytalux™ (pafolacianine) injection at two different administration time windows in adult subjects undergoing surgery for known or suspected cancer in the lung or ovarian cancer.
The study will enroll adult patients with either malignant or non-malignant lung lesions with known or suspected lung cancer, or patients with a confirmed diagnosis of ovarian cancer, who are scheduled to undergo surgical resection. Cytalux™ (pafolacianine) injection is an FDA-approved optical imaging agent indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer, and for malignant lesions in adults with ovarian cancer.
Eligible participants will receive a single intravenous dose of Cytalux™ at the FDA-approved dose of 0.025 mg/kg. The dose level will remain consistent with the approved labeling. Participants will be assigned to one of two dosing windows.
During surgery, intraoperative molecular imaging will be performed to assess tumor fluorescence following administration of Cytalux™.
The primary objective of the study is to demonstrate non-inferiority of Cytalux™ administration within an extended dosing window of 120-168 hours prior to surgery compared with the currently approved administration windows (lung: 1-24 hours; ovarian: 1-9 hours).
- Conditions
- Cancer in the Lung, Ovarian Cancer
- Being tested
- CYTALUX (pafolacianine) injection
- Keywords
- cancer in the lung, lung cancer, ovarian cancer, lung cancer surgery, ovarian cancer surgery, CYTALUX, pafolacianine, fluorescent, molecular imaging
- Medical subject headings
- Ovarian Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYTALUX (pafolacianine) injectionDrug
Also called pafolacianine injection
CYTALUX™ (PAFOLACIANINE) INJECTION: folate analog ligand conjugated with an indole cyanine green-like dye. Each subject will be administered a single intravenous dose (0.025 mg/kg) based on their assigned cohort before initiation of intraoperative NIR fluorescent imaging
| Study group | Role | What they receive |
|---|---|---|
| Lung dosing 1-24 hours prior to imaging | Active comparator | Subjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 1-24 hours prior to imaging Receives: Drug: CYTALUX (pafolacianine) injection |
| Lung dosing 120-168 hours prior to imaging | Experimental | Subjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging Receives: Drug: CYTALUX (pafolacianine) injection |
| Ovarian dosing 1-9 hours prior to imaging | Active comparator | Subjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 1-9 hours prior to imaging Receives: Drug: CYTALUX (pafolacianine) injection |
| Ovarian dosing 120-168 hours prior to imaging | Experimental | Subjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging Receives: Drug: CYTALUX (pafolacianine) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-to-background ratio
Mean difference in in-situ tumor-to-background ratio (TBR) between 120-168 hours and the approved window
Measured: 1 day
Secondary outcomes (2)
Sensitivity
The sensitivity of Cytalux™ (pafolacianine) with NIR imaging for detection of malignant and non-malignant lung lesions and malignant ovarian cancer lesions. The sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer.
Measured: 1 day
Sensitivity of folate receptor-positive lesions
The sensitivity of Cytalux with NIR imaging for detection of malignant and non-malignant lung lesions and for malignant ovarian cancer lesions that are confirmed to be folate receptor alpha and/or folate receptor beta positive
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Aug 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer in the LungStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Lung and ovarian subjects will be classified equally into one of two dosing cohorts as defined below: * Lung Cohort 1: Subjects with malignant and non-malignant lesions in the lung dosed 1-24 hours prior to imaging * Lung Cohort 2: Subjects with malignant and non-malignant lesions in the lung dosed 120 - 168 hours prior to imaging * Ovarian Cohort 1: Subjects with ovarian cancer dosed 1-9 hours prior to imaging * Ovarian Cohort 2: Subjects with ovarian cancer dosed 120 - 168 hours prior to imaging
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- On Target Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469202
- Sponsor's protocol ID
- OTL38-2026-009
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Information is not relevant to other researchers
Publications
Tanyi JL, Randall LM, Chambers SK, Butler KA, Winer IS, Langstraat CL, Han ES, Vahrmeijer AL, Chon HS, Morgan MA, Powell MA, Tseng JH, Lopez AS, Wenham RM. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006). J Clin Oncol. 2023 Jan 10;41(2):276-284. doi: 10.1200/JCO.22.00291. Epub 2022 Sep 7.
PubMed 36070540Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3.
PubMed 37019717
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07469202
- Acronym / sponsor ID
- OTL38-2026-009
- Conditions
- Cancer in the Lung, Ovarian Cancer
- Keywords
- cancer in the lung, lung cancer, ovarian cancer, lung cancer surgery, ovarian cancer surgery, CYTALUX, pafolacianine, fluorescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- On Target Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Mar 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 goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. This study is being done in adult patients undergoing surgery for malignant or non-malignant lung lesions or for confirmed ovarian cancer.
Detailed description
This is a prospective, multicenter, open-label, non-inferiority study designed to evaluate the clinical adequacy of intraoperative tumor fluorescence following administration of Cytalux™ (pafolacianine) injection at two different administration time windows in adult subjects undergoing surgery for known or suspected cancer in the lung or ovarian cancer.
The study will enroll adult patients with either malignant or non-malignant lung lesions with known or suspected lung cancer, or patients with a confirmed diagnosis of ovarian cancer, who are scheduled to undergo surgical resection. Cytalux™ (pafolacianine) injection is an FDA-approved optical imaging agent indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer, and for malignant lesions in adults with ovarian cancer.
Eligible participants will receive a single intravenous dose of Cytalux™ at the FDA-approved dose of 0.025 mg/kg. The dose level will remain consistent with the approved labeling. Participants will be assigned to one of two dosing windows.
During surgery, intraoperative molecular imaging will be performed to assess tumor fluorescence following administration of Cytalux™.
The primary objective of the study is to demonstrate non-inferiority of Cytalux™ administration within an extended dosing window of 120-168 hours prior to surgery compared with the currently approved administration windows (lung: 1-24 hours; ovarian: 1-9 hours).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Lung and ovarian subjects will be classified equally into one of two dosing cohorts as defined below: * Lung Cohort 1: Subjects with malignant and non-malignant lesions in the lung dosed 1-24 hours prior to imaging * Lung Cohort 2: Subjects with malignant and non-malignant lesions in the lung dosed 120 - 168 hours prior to imaging * Ovarian Cohort 1: Subjects with ovarian cancer dosed 1-9 hours prior to imaging * Ovarian Cohort 2: Subjects with ovarian cancer dosed 120 - 168 hours prior to imaging
| Arm | Type | Receives |
|---|---|---|
| Lung dosing 1-24 hours prior to imaging | Active comparator | Drug: CYTALUX (pafolacianine) injectionSubjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 1-24 hours prior to imaging |
| Lung dosing 120-168 hours prior to imaging | Experimental | Drug: CYTALUX (pafolacianine) injectionSubjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging |
| Ovarian dosing 1-9 hours prior to imaging | Active comparator | Drug: CYTALUX (pafolacianine) injectionSubjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 1-9 hours prior to imaging |
| Ovarian dosing 120-168 hours prior to imaging | Experimental | Drug: CYTALUX (pafolacianine) injectionSubjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients 18 years of age and older
- Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer
- Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking/cytoreduction
- Willingness of research participant or legal guardian/representative to give written informed consent
Key exclusion criteria (8 listed)
- History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
- History of allergy to any of the components of Cytalux™ (pafolacianine)
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
- Known sensitivity to fluorescent light
- Impaired renal function defined as eGFR< 50 mL/min/1.73m2
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 |
|---|---|---|
| CYTALUX (pafolacianine) injectionAlso: pafolacianine injectionCYTALUX™ (PAFOLACIANINE) INJECTION: folate analog ligand conjugated with an indole cyanine green-like dye. Each subject will be administered a single intravenous dose (0.025 mg/kg) based on their assigned cohort before initiation of intraoperative NIR fluorescent imaging | Drug | Lung dosing 1-24 hours prior to imaging, Lung dosing 120-168 hours prior to imaging, Ovarian dosing 1-9 hours prior to imaging, Ovarian dosing 120-168 hours prior to imaging |
Primary outcome
Tumor-to-background ratio
Time frame: 1 day
Mean difference in in-situ tumor-to-background ratio (TBR) between 120-168 hours and the approved window
2 secondary outcomes
Sensitivity
Time frame: 1 day
Sensitivity of folate receptor-positive lesions
Time frame: 1 day
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 18 Aug 2026.
- Background: PubMed 36070540Tanyi JL, Randall LM, Chambers SK, Butler KA, Winer IS, Langstraat CL, Han ES, Vahrmeijer AL, Chon HS, Morgan MA, Powell MA, Tseng JH, Lopez AS, Wenham RM. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006). J Clin Oncol. 2023 Jan 10;41(2):276-284. doi: 10.1200/JCO.22.00291. Epub 2022 Sep 7.
- Background: PubMed 37019717Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Information is not relevant to other researchers
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CYTALUX (pafolacianine) injection in people with Cancer in the Lung and Ovarian Cancer, run by On Target Laboratories, LLC.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Tina Barrett (765-588-4547, tbarrett@ontargetlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-to-background ratio (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 NCT07469202, which also lists 2 linked publications.
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 18 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.