Lung DiseasesPhase 2NCT03598309
Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers
A Phase 2 study testing Curcumin C3 complex® and Lovaza® in people with Lung Diseases and Lung Cancer, Protection Against, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out if an investigational combination drug called Lovaza (made with fish oils)+Curcumin C3 Complex (made from a root called curcumin) can help reduce the size of lung nodules. Researchers also want to find out if the combination of Lovaza+Curcumin C3 Complex is safe and tolerable. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Lung Cancer, Protection Against
- What is being tested?
- Curcumin C3 complex® and Lovaza®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to May 2026
- Phase
- Phase 2
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 55 years of age or older
- Former smokers and current enrolled in LDCT lung cancer screening or those who are detected using a regular CT, and have Lung-RADS 3 category lesion(s), that would get a 6 month f/u LDCT or regular CT based on Lung-RADS recommendations or former and current smokers enrolled in LDCT lung cancer screening, or regular CT and have Lung-RADS 2 category lesions with part-solid or non-solid lung nodule ≥4mm mean diameter detected during screening LDCT or regular CT scans
- History of cigarette smoking with ≥ 20 pack years
- All current smokers should accept to receive smoking cessation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
- Able to swallow study pills
Show all 14Show fewer
- Able to undergo CT
- Not allergic to components of study agents
- Willing to discontinue current vitamin/mineral supplement use containing components of study agents. A standard multivitamin supplement provided for the study
- Willing to comply with proposed visit and treatment schedule
- Able to understand and willing to sign a written informed consent document
- Participants must have normal organ and marrow function
- Willing to use contraception during the intervention period of 6 months (males and females)
- Not pregnant or lactating nor planning to become pregnant or lactate during the 6 month study intervention period..
Who cannot join
- Invasive cancer diagnosis (excluding basal cell carcinoma or skin squamous cell carcinoma) diagnosed within the last 2 years
- Inability to undergo CT
- Newly diagnosed nodule meeting Lung-RADS 4 criteria
- Have taken doxycycline or tetracycline less than or equal to 2 weeks
- Females- pregnant or lactating (throughout the duration of intervention of 6 months)
- Unwilling to use effective form of birth control (Males and females) (throughout the duration of intervention of 6 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers
The purpose of this study is to find out if an investigational combination drug called Lovaza (made with fish oils)+Curcumin C3 Complex (made from a root called curcumin) can help reduce the size of lung nodules. Researchers also want to find out if the combination of Lovaza+Curcumin C3 Complex is safe and tolerable.
- Conditions
- Lung Diseases, Lung Cancer, Protection Against
- Being tested
- Curcumin C3 complex®, Lovaza®, Placebo
- Keywords
- Lung RADS 3, Lung nodule, Lung cancer risk, Chemoprevention
- Medical subject headings
- Lung Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin C3 complex®Drug
Also called Curcuminoid
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Lovaza®Drug
Also called Omega-3-Acid Ethyl Esters
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
PlaceboOther
Also called Pill with no drug or other active ingredients in it.
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin C3 complex® +Lovaza® | Active comparator | Group A:
4 grams Lovaza®, 2 grams twice a day (BID). 2 grams by mouth daily, AM and PM 8,000 mgs CUR Curcumin C3 complex® tablets, divided into 2 doses. 4 grams by mouth, twice a day, AM and PM. Receives: Drug: Curcumin C3 complex®; Drug: Lovaza® |
| Curcumin C3 complex® +Lovaza® +Placebo | Active comparator | Group B:
2 grams Lovaza®, 1 gram twice a day, AM and PM. 4,000 mgs CUR Curcumin C3 complex® tablets, 2,000 mgs twice a day, AM and PM.
1 placebo capsule twice a day, AM and PM. Receives: Drug: Curcumin C3 complex®; Drug: Lovaza®; Other: Placebo |
| Placebo only | Active comparator | Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Bronchial Nodule Size
Difference in the average change in bronchial nodule size from baseline to end of therapy at 6 months for each study arm. A lower size is taken to be the desired value for participants receiving study drug, assuming an increase in size for the placebo arm.
Measured: 6 months post treatment
Rate of Nodules ≥4 mm
Number of nodules ≥4 mm per study arm, post treatment.
Measured: 6 months post treatment
Secondary outcomes (2)
Rate of Adherence
Rate of participant adherence per study arm. Proof of adherence based on study team pill counts, participant diet logs and pill logs at end of study, vs. data collected at midpoint.
Measured: 6 months post treatment
Rate of Treatment Related Adverse Events (AEs)
Safety of the combined agents (Curcumin C3 complex® + Lovaza®) at 2 dose arms vs. placebo as indicated by incidence of related adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0.
Measured: Up to 30 days post treatment, approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start5 Jun 2019
- Primary completion29 May 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Responsible party
- Sponsor
- Investigators
- Nagi Kumar, Ph.D, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598309
- Sponsor's protocol ID
- MCC-19622
- Other IDs
- 8JK03
- Status last verified
- Feb 2026
- First submitted
- 13 Jul 2018
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers
- ClinicalTrials.gov ID
- NCT03598309
- Acronym / sponsor ID
- MCC-19622
- Conditions
- Lung Diseases, Lung Cancer, Protection Against
- Keywords
- Lung RADS 3, Lung nodule, Lung cancer risk, Chemoprevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Jul 2018 (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 purpose of this study is to find out if an investigational combination drug called Lovaza (made with fish oils)+Curcumin C3 Complex (made from a root called curcumin) can help reduce the size of lung nodules. Researchers also want to find out if the combination of Lovaza+Curcumin C3 Complex is safe and tolerable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Curcumin C3 complex® +Lovaza® | Active comparator | Drug: Curcumin C3 complex®, Drug: Lovaza®Group A: 4 grams Lovaza®, 2 grams twice a day (BID). 2 grams by mouth daily, AM and PM 8,000 mgs CUR Curcumin C3 complex® tablets, divided into 2 doses. 4 grams by mouth, twice a day, AM and PM. |
| Curcumin C3 complex® +Lovaza® +Placebo | Active comparator | Drug: Curcumin C3 complex®, Drug: Lovaza®, Other: PlaceboGroup B: 2 grams Lovaza®, 1 gram twice a day, AM and PM. 4,000 mgs CUR Curcumin C3 complex® tablets, 2,000 mgs twice a day, AM and PM. 1 placebo capsule twice a day, AM and PM. |
| Placebo only | Active comparator | Other: PlaceboPlacebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, 55 years of age or older
- Former smokers and current enrolled in LDCT lung cancer screening or those who are detected using a regular CT, and have Lung-RADS 3 category lesion(s), that would get a 6 month f/u LDCT or regular CT based on Lung-RADS recommendations or former and current smokers enrolled in LDCT lung cancer screening, or regular CT and have Lung-RADS 2 category lesions with part-solid or non-solid lung nodule ≥4mm mean diameter detected during screening LDCT or regular CT scans
- History of cigarette smoking with ≥ 20 pack years
- All current smokers should accept to receive smoking cessation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
Key exclusion criteria (6 listed)
- Invasive cancer diagnosis (excluding basal cell carcinoma or skin squamous cell carcinoma) diagnosed within the last 2 years
- Inability to undergo CT
- Newly diagnosed nodule meeting Lung-RADS 4 criteria
- Have taken doxycycline or tetracycline less than or equal to 2 weeks
- Females- pregnant or lactating (throughout the duration of intervention of 6 months)
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 |
|---|---|---|
| Curcumin C3 complex®Also: CurcuminoidGroups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants. | Drug | Curcumin C3 complex® +Lovaza®, Curcumin C3 complex® +Lovaza® +Placebo |
| Lovaza®Also: Omega-3-Acid Ethyl EstersGroups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants. | Drug | Curcumin C3 complex® +Lovaza®, Curcumin C3 complex® +Lovaza® +Placebo |
| PlaceboAlso: Pill with no drug or other active ingredients in it.Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants. | Other | Curcumin C3 complex® +Lovaza® +Placebo, Placebo only |
Primary outcome
Mean Change in Bronchial Nodule Size
Time frame: 6 months post treatment
Difference in the average change in bronchial nodule size from baseline to end of therapy at 6 months for each study arm. A lower size is taken to be the desired value for participants receiving study drug, assuming an increase in size for the placebo arm.
Rate of Nodules ≥4 mm
Time frame: 6 months post treatment
Number of nodules ≥4 mm per study arm, post treatment.
2 secondary outcomes
Rate of Adherence
Time frame: 6 months post treatment
Rate of Treatment Related Adverse Events (AEs)
Time frame: Up to 30 days post treatment, approximately 7 months
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 27 Feb 2026.
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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.
Nagi Kumar, Ph.D principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin C3 complex® and Lovaza® in people with Lung Diseases and Lung Cancer, Protection Against, run by H. Lee Moffitt Cancer Center and Research Institute 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 14 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 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 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?
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?
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?
Mean Change in Bronchial Nodule Size (time frame: 6 months post treatment). The study lists 2 primary outcomes in all. 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 27 Feb 2026.