Squamous Cell Lung CarcinomaPhase 2NCT02920476
TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003)
A Phase 2 study testing TAS-102 in people with Squamous Cell Lung Carcinoma, run by University of Florida at 1 site in United States.
Trial summary
This is a non-randomized, open label, sequentially enrolling phase II study with a Simon two-step enrollment design to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Squamous Cell Lung Carcinoma
- What is being tested?
- TAS-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 14 Aug 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who will be eligible will be all patients with unresectable and/or metastatic squamous cell non-small cell lung cancer who have disease which has been previously treated with an Food \& Drug Administration (FDA)- or National Comprehensive Cancer Network (NCCN)-approved platinum doublet. Patients who have not received such therapy must have medical reasons for not receiving such therapy. Those who have a molecularly targetable genetic mutation in their tumor must have also received the appropriate specific therapy for that mutation. All will be appropriate candidates for chemotherapy treatment.
- Subjects must meet all of the additional following criteria to be eligible for study participation:
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- Life expectancy > 12 weeks
- Male or female' age >18 years
- Patients of childbearing potential must be using an effective means of contraception.
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- Histologic diagnosis of squamous non-small cell lung cancer that has been treated adequately in the metastatic or unresectable setting with a platinum doublet chemotherapy regimen and now has evidence of disease progression. Patients may have also received additional chemotherapy, such as an immune checkpoint inhibitor or no more than one additional cytotoxic agent (thus participants may have received between one to three prior lines of therapy for metastatic or unresectable disease).
- Patients who have received platinum-based doublet therapy in the neoadjuvant or adjuvant setting will only be eligible if they have experienced disease progression after their last dose of cytotoxic chemotherapy.
- Patients who have a neoplasm for which there currently exists an FDA-approved targeted therapy (such as to epidermal growth factor receptor [EGFR] activating mutations, or ALK or ROS1 gene rearrangements) must have received all such targeted therapies and either exhibited progressive disease through such treatments, or have been shown to be intolerant of such therapies, prior to enrollment on this study.
- Baseline laboratory values (bone marrow, renal, hepatic):
- Adequate bone marrow function:
- Absolute neutrophil count >1000/µL
- Platelet count >100'000/µL
- Renal function:
- Serum creatinine < 2.0 mg/dL
- Hepatic function:
- Bilirubin <1.5x upper limit of normal (ULN)
- Serum calcium < 12 mg/dL
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 6 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
- Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or
- For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
- Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 3 months following the last dose of study drug.
- Subjects must have provided written informed consent and be willing to comply with all study-related procedures.
Who cannot join
- Pregnant or lactating females
- Patients with a mixed histology NSCLC, such as adenosquamous carcinoma, where the squamous component is <50% of the assessed lesion
- Patients with a mixed histology where there are any small cell elements
- Patients who have not received and progressed through, refused, or been intolerant of, a commonly utilized platinum-doublet therapy (cisplatin or carboplatin paired with docetaxel, paclitaxel, nab-paclitaxel, gemcitabine, vinorelbine, etoposide or irinotecan) administered for the treatment of unresectable or metastatic lung cancer.
- Patients who have not received the appropriate prior targeted therapy for their lung cancer if eligible
- Any invasive malignancy treated within 3 years prior to Cycle 1, Day 1
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- Myocardial infarction or ischemia within the 6 months before Cycle 1' Day 1
- Uncontrolled' clinically significant dysrhythmia, or prolonged QT segment
- Uncontrolled malignant disease in the central nervous system (previously treated disease is eligible, provided it has been radiographically stable for at least four weeks)
- Radiotherapy within the 2 weeks before Cycle 1, Day 1. If any radiation has been administered to the target lesion there must be evidence of growth by radiographic assessments or physical examination
- Major surgery within the 2 weeks before Cycle 1, Day 1
- Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
- Subjects unwilling to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug.
- History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Carcinoma of the Lung
This is a non-randomized, open label, sequentially enrolling phase II study with a Simon two-step enrollment design to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of unresectable or metastatic recurrent squamous non-small cell lung cancers.
- Conditions
- Squamous Cell Lung Carcinoma
- Being tested
- TAS-102
- Keywords
- lung, metastatic, carcinoma
- Medical subject headings
- Neoplasm Metastasis, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102Drug
Also called Lonsurf
Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.
Days 6 through 7: Rest
Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
Days 13 through 28: Rest
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | TAS-102 Receives: Drug: TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
To determine the percentage of subjects who achieve an objective response by RECIST 1.1 criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions. Subjects must have received at least 2 cycles of therapy to be evaluable for this outcome measure.
Measured: 1 year
Secondary outcomes (2)
Clinical Benefit Rate
To determine the percentage of subjects who derive clinical benefit by RECIST 1.1 criteria. The clinical benefit rate is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.
Measured: 1 year
Overall Survival (OS)
To determine the overall survival in days
Measured: 1095 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start19 Jul 2017
- Primary completion3 Dec 2018
- Study completion14 Aug 2021
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.
- Other trials for Squamous Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Dennie Jones, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920476
- Sponsor's protocol ID
- IRB201601359 -A
- Other IDs
- UF-STO-LUNG-003, IIT-USA-0113, OCR15277
- Status last verified
- May 2022
- First submitted
- 27 Sep 2016
- Last updated
- 23 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT02920476
- Acronym / sponsor ID
- IRB201601359 -A
- Conditions
- Squamous Cell Lung Carcinoma
- Keywords
- lung, metastatic, carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Taiho Oncology, Inc.
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, open label, sequentially enrolling phase II study with a Simon two-step enrollment design to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of unresectable or metastatic recurrent squamous non-small cell lung cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: TAS-102TAS-102 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Those who will be eligible will be all patients with unresectable and/or metastatic squamous cell non-small cell lung cancer who have disease which has been previously treated with an Food \& Drug Administration (FDA)- or National Comprehensive Cancer Network (NCCN)-approved platinum doublet. Patients who have not received such therapy must have medical reasons for not receiving such therapy. Those who have a molecularly targetable genetic mutation in their tumor must have also received the appropriate specific therapy for that mutation. All will be appropriate candidates for chemotherapy treatment.
- Subjects must meet all of the additional following criteria to be eligible for study participation:
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- Life expectancy > 12 weeks
- Male or female' age >18 years
Key exclusion criteria (17 listed)
- Pregnant or lactating females
- Patients with a mixed histology NSCLC, such as adenosquamous carcinoma, where the squamous component is <50% of the assessed lesion
- Patients with a mixed histology where there are any small cell elements
- Patients who have not received and progressed through, refused, or been intolerant of, a commonly utilized platinum-doublet therapy (cisplatin or carboplatin paired with docetaxel, paclitaxel, nab-paclitaxel, gemcitabine, vinorelbine, etoposide or irinotecan) administered for the treatment of unresectable or metastatic lung cancer.
- Patients who have not received the appropriate prior targeted therapy for their lung cancer if eligible
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 |
|---|---|---|
| TAS-102Also: LonsurfDays 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest | Drug | Treatment arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 year
To determine the percentage of subjects who achieve an objective response by RECIST 1.1 criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions. Subjects must have received at least 2 cycles of therapy to be evaluable for this outcome measure.
2 secondary outcomes
Clinical Benefit Rate
Time frame: 1 year
Overall Survival (OS)
Time frame: 1095 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dennie Jones, MD principal investigator
University of Florida
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 TAS-102 in people with Squamous Cell Lung Carcinoma, run by University of Florida 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 23 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: finished, as of the sponsor's last update on 23 Jun 2022. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2019). 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?
Objective Response Rate (ORR) (time frame: 1 year). 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 23 Jun 2022.