Non Small Cell Lung CancerPhase 3FORTIS-CNCT00706862
Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer
A Phase 3 study testing Talactoferrin in people with Non Small Cell Lung Cancer, run by Agennix at 6 sites in United States.
Trial summary
The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Talactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2009to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable
- At least 1 unirradiated target lesion measurable by RECIST
- Adequate hematologic, renal and hepatic function
- ECOG 0,1
- Able to understand and sign an Informed Consent
Who cannot join
- Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
- Received prior systemic anti-cancer therapy for NSCLC
- History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs
- Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
- History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥5 years
- Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
Show all 17Show fewer
- Serious active infection
- Psychiatric illness/social situations that would limit study compliance
- Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic
- Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)
- Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
- Known HIV positive or on active anti-retroviral therapy
- Known Hepatitis B surface antigen positive or hepatitis C positive
- Receipt of any investigational medication within 4 weeks prior to randomization
- Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and for 30 days after completion of treatment
- Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
- Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, 37404
Davey Daniel
- Withdrawn
Rush University Medical Center
Chicago, Illinois, 60612
- Recruiting
City of Hope
Duarte, California, 91010
Karen Reckamp
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Jeffrey Crawford
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
David Spigel
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Missak Haigentz
About this study
Official title: FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Talactoferrin, Placebo
- Keywords
- Non small cell lung cancer, Talactoferrin, Dendritic cell recruiter and activator, DCRA, Immunomodulatory agent, Lactoferrin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalactoferrinDrug
Also called talactoferrin alfa, TLF, recombinant human talactoferrin, rhLF
Oral, 1.5 grams twice per day
PlaceboDrug
Oral, twice per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Talactoferrin, Carboplatin, Paclitaxel Receives: Drug: Talactoferrin |
| 2 | Placebo comparator | Placebo, Carboplatin, Paclitaxel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: After the occurence of the required number of events
Progression free survival
Measured: At the time of final analysis
Secondary outcomes (2)
Objective response and disease stabilization rate
Measured: At the time of final analysis
Safety and tolerability
Measured: At the time of final analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startFeb 2009
- Primary completionJun 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agennix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706862
- Sponsor's protocol ID
- LF-0208
- Acronym
- FORTIS-C
- Status last verified
- Mar 2012
- First submitted
- 26 Jun 2008
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00706862
- Acronym / sponsor ID
- FORTIS-C / LF-0208
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, Talactoferrin, Dendritic cell recruiter and activator, DCRA, Immunomodulatory agent, Lactoferrin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- AgennixIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 30 Jun 2008 (estimated)
- 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 the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TalactoferrinTalactoferrin, Carboplatin, Paclitaxel |
| 2 | Placebo comparator | Drug: PlaceboPlacebo, Carboplatin, Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable
- At least 1 unirradiated target lesion measurable by RECIST
- Adequate hematologic, renal and hepatic function
- ECOG 0,1
- Able to understand and sign an Informed Consent
Key exclusion criteria (17 listed)
- Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
- Received prior systemic anti-cancer therapy for NSCLC
- History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs
- Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
- History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥5 years
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 |
|---|---|---|
| TalactoferrinAlso: talactoferrin alfa, TLF, recombinant human talactoferrin, rhLFOral, 1.5 grams twice per day | Drug | 1 |
| PlaceboOral, twice per day | Drug | 2 |
Primary outcome
Overall Survival
Time frame: After the occurence of the required number of events
Progression free survival
Time frame: At the time of final analysis
2 secondary outcomes
Objective response and disease stabilization rate
Time frame: At the time of final analysis
Safety and tolerability
Time frame: At the time of final analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Talactoferrin in people with Non Small Cell Lung Cancer, run by Agennix at 6 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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yenyun Wang, MD (713-552-1091, ywang@agennix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: After the occurence of the required number of events). 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 15 Mar 2012.