EGFR Mutation Positive Non Small Cell Lung CancerPhase 1/2NCT02906163
First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy
A Phase 1/2 study testing Thymalfasin (Thymosin alpha 1, Ta1) and SoC (tyrosine kinase inhibitor) in people with EGFR Mutation Positive Non Small Cell Lung Cancer, run by SciClone Pharmaceuticals at 5 sites in Italy.
Trial summary
Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha 1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Mutation Positive Non Small Cell Lung Cancer
- What is being tested?
- Thymalfasin (Thymosin alpha 1, Ta1) and SoC (tyrosine kinase inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 5 sitesItaly
- Study dates
- Oct 2016to Jan 2020
- Phase
- Phase 1/2
- 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
- Age 18 years or older
- Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study (see major details in section 8 for the minimum sample characteristics)
- Activating mutations of EGFRdiagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastaticNSCLC, not amenable to curative surgery or radiotherapy
- Measurable disease by Response Evaluation Criteria In Solid Tumours (RECIST) in a lesion not previously irradiated or non-measurable disease (non measurable disease only for Phase I)
- Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2
- Absolute neutrophil count (ANC) > 1.5 x 109/liter (L) and platelets > 100 x 109/L
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- Bilirubin level either normal or <1.5 x ULN
- AST (SGOT) and ALT (SGPT) <2.5 x ULN (≤ 5 x ULN if liver metastases are present)
- Serum creatinine <1.5 x ULN
- Effective contraception for both, male and female patients, if the risk of conception exists
- Provision of written informed consent to the analysis of biological markers (registration)
Who cannot join
- Prior therapy with Thymosin alpha-1
- Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
- Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies
- Radiotherapy within 14 days prior to drug administration, except as follows:
- Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
- Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
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- Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days
- Patients with toxicities that have not coming back (at least) to grade 1
- Pregnancy or suspected pregnancy
- Known severe hypersensitivity to TKI
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- As judged by the investigator, any inflammatory changes of the surface of the eye
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Trial locations and contacts
5 sites in 1 country.
Carlo Tomino, MD contact
5 sites in 1 country
Italy5 sites
Azienda Sanitaria Locale Frosinone
Frosinone
Dott.ssa Teresa Gamucci
Dott.ssa Teresa Gamucci
Istituto Nazionale dei Tumori
Milan
Dott.ssa Marina Chiara Garassino
Dott.ssa Marina Chiara Garassino
Roma_Campus Bio-Medico
Rome
Prof. Daniele Santini
Prof. Daniele Santini
Sant'Andrea Hospital
Rome
Prof. Paolo Marchetti
Prof. Paolo Marchetti
Presidio Sanitario San Camillo
Torino
Dott.ssa Maria Rita Migliorino
Dott.ssa Maria Rita Migliorino
About this study
Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha 1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy.
Phase II: evaluate the efficacy in terms of PFS of Thymosin alpha 1 in patients with advanced EGFR mutant NSCLC taking SoC as compared to SoC alone.
Read the detailed description
Phase I/Phase II, multi-center, open label, randomized, parallel group study to determine the safety/tolerability/efficacy of Thymosin alpha 1 in patients with sensitizing EGFR mutation positive NSCLC taking SoC versus SoC alone. The study will be conducted in subjects with sensitizing EGFR mutation positive Non Small Cell Lung Cancer. Subjects with sensitizing EGFR mutation positive NSCLC will be screened for eligibility by the clinical center involved. The study will be conducted in two parts. In Phase I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II. In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months.
- Being tested
- Thymalfasin (Thymosin alpha 1, Ta1), SoC (tyrosine kinase inhibitor)
- Keywords
- EGFR mutation positive, Thymosin Alpha 1, Tyrosine Kinase inhibitor, Thymalfasin, Non Small Cell Lung Cancer
- 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.
Thymalfasin (Thymosin alpha 1, Ta1)Drug
Also called ZADAXIN
In Phase I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II.
SoC (tyrosine kinase inhibitor)Drug
Also called afatinib, gefitinib, erlotinib
In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Thymalfasin biw plus SoC (tyrosine kinase inhibitor) | Experimental | Twice weekly thymalfasin Receives: Drug: Thymalfasin (Thymosin alpha 1, Ta1); Drug: SoC (tyrosine kinase inhibitor) |
| Thymalfasin plus SoC (tyrosine kinase inhibitor) | Experimental | 5 times a week thymalfasin Receives: Drug: Thymalfasin (Thymosin alpha 1, Ta1); Drug: SoC (tyrosine kinase inhibitor) |
| SoC (tyrosine kinase inhibitor) | Active comparator | 12 months Receives: Drug: SoC (tyrosine kinase inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-related adverse events
Measured: Up to 4 months
PFS
Measured: Up to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation Positive 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Paolo Marchetti, MD, Principal investigator, S. Andrea Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906163
- Sponsor's protocol ID
- SCI-Ta1-NSCLC-P1/2-001
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy
- ClinicalTrials.gov ID
- NCT02906163
- Acronym / sponsor ID
- SCI-Ta1-NSCLC-P1/2-001
- Keywords
- EGFR mutation positive, Thymosin Alpha 1, Tyrosine Kinase inhibitor, Thymalfasin, Non Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Sep 2016 (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.
Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha 1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy.
Phase II: evaluate the efficacy in terms of PFS of Thymosin alpha 1 in patients with advanced EGFR mutant NSCLC taking SoC as compared to SoC alone.
Detailed description
Phase I/Phase II, multi-center, open label, randomized, parallel group study to determine the safety/tolerability/efficacy of Thymosin alpha 1 in patients with sensitizing EGFR mutation positive NSCLC taking SoC versus SoC alone. The study will be conducted in subjects with sensitizing EGFR mutation positive Non Small Cell Lung Cancer. Subjects with sensitizing EGFR mutation positive NSCLC will be screened for eligibility by the clinical center involved. The study will be conducted in two parts. In Phase I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II. In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thymalfasin biw plus SoC (tyrosine kinase inhibitor) | Experimental | Drug: Thymalfasin (Thymosin alpha 1, Ta1), Drug: SoC (tyrosine kinase inhibitor)Twice weekly thymalfasin |
| Thymalfasin plus SoC (tyrosine kinase inhibitor) | Experimental | Drug: Thymalfasin (Thymosin alpha 1, Ta1), Drug: SoC (tyrosine kinase inhibitor)5 times a week thymalfasin |
| SoC (tyrosine kinase inhibitor) | Active comparator | Drug: SoC (tyrosine kinase inhibitor)12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older
- Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study (see major details in section 8 for the minimum sample characteristics)
- Activating mutations of EGFRdiagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastaticNSCLC, not amenable to curative surgery or radiotherapy
- Measurable disease by Response Evaluation Criteria In Solid Tumours (RECIST) in a lesion not previously irradiated or non-measurable disease (non measurable disease only for Phase I)
- Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2
Key exclusion criteria (15 listed)
- Prior therapy with Thymosin alpha-1
- Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
- Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies
- Radiotherapy within 14 days prior to drug administration, except as follows:
- Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
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 |
|---|---|---|
| Thymalfasin (Thymosin alpha 1, Ta1)Also: ZADAXINIn Phase I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II. | Drug | Thymalfasin biw plus SoC (tyrosine kinase inhibitor), Thymalfasin plus SoC (tyrosine kinase inhibitor) |
| SoC (tyrosine kinase inhibitor)Also: afatinib, gefitinib, erlotinibIn Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months. | Drug | SoC (tyrosine kinase inhibitor), Thymalfasin biw plus SoC (tyrosine kinase inhibitor), Thymalfasin plus SoC (tyrosine kinase inhibitor) |
Primary outcome
Number of treatment-related adverse events
Time frame: Up to 4 months
PFS
Time frame: Up to12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- 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. This study is not recruiting at the moment.
Carlo Tomino, MD contact
Prof. Paolo Marchetti, MD principal investigator
S. Andrea Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Thymalfasin (Thymosin alpha 1, Ta1) and SoC (tyrosine kinase inhibitor) in people with EGFR Mutation Positive Non Small Cell Lung Cancer, run by SciClone Pharmaceuticals at 5 sites in Italy.
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 11 inclusion and 15 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 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Tomino, MD (carlotomino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-related adverse events (time frame: Up to 4 months). 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 19 Sep 2016.