Non-Small Cell Lung CancerPhase 2NCT02906150
Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type
A Phase 2 study testing Thymalfasin (Thymosin alpha 1, Ta1) and SoC (chemotherapy and platinum agent) in people with Non-Small Cell Lung Cancer, run by SciClone Pharmaceuticals at 8 sites in Italy.
Trial summary
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type 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?
- Thymalfasin (Thymosin alpha 1, Ta1) and SoC (chemotherapy and platinum agent)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesItaly
- Study dates
- Sep 2016to Jul 2019
- Phase
- Phase 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 EGFR diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastatic NSCLC, 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 come back (at least) to grade 1
- Pregnancy or suspected pregnancy
- Known severe hypersensitivity to TKI products
- 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
8 sites in 1 country.
Carlo Tomino, MD contact
8 sites in 1 country
Italy8 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
Roma_Gemelli
Rome
Prof. Carlo Antonio Mario Barone
Prof. Carlo Antonio Mario Barone
Roma_Regina Apostolorum
Rome
Dott. Francesco Angelini
Dott. Francesco Angelini
Roma_Tor Vergata
Rome
Prof. Mario Roselli
Prof. Mario Roselli
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
Official title: Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) Chemotherapy Plus Cisplatin (or Carboplatin) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Thymalfasin (Thymosin alpha 1, Ta1), SoC (chemotherapy and platinum agent)
- Keywords
- EGFR Wild Type, Thymosin Alpha 1, Non-Small Cell Lung Cancer, Thymalfasin
- 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
Patients will be randomized to Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.
SoC (chemotherapy and platinum agent)Drug
Also called Pemetrexed, carboplatin or cisplatin
Patients will be randomized to SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Thymalfasin (Thymosin alpha 1, Ta1) | Experimental | Arm A: 70 patients will receive Thymosin alpha 1 in 1mL SC injection five times a week (first four months); then two times a week for eight months. SoC chemotherapy and cisplatin (or carboplatin) for twelve months. Receives: Drug: Thymalfasin (Thymosin alpha 1, Ta1); Drug: SoC (chemotherapy and platinum agent) |
| SoC (chemotherapy and platinum agent) | Active comparator | Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve months. Receives: Drug: SoC (chemotherapy and platinum agent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression free survival (PFS)
Measured: Up to 12 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 startSep 2016
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906150
- Sponsor's protocol ID
- SCI-Ta1-NSCLC-CHEMO P2-001
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) Chemotherapy Plus Cisplatin (or Carboplatin) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type
- ClinicalTrials.gov ID
- NCT02906150
- Acronym / sponsor ID
- SCI-Ta1-NSCLC-CHEMO P2-001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR Wild Type, Thymosin Alpha 1, Non-Small Cell Lung Cancer, Thymalfasin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (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.
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymalfasin (Thymosin alpha 1, Ta1) | Experimental | Drug: Thymalfasin (Thymosin alpha 1, Ta1), Drug: SoC (chemotherapy and platinum agent)Arm A: 70 patients will receive Thymosin alpha 1 in 1mL SC injection five times a week (first four months); then two times a week for eight months. SoC chemotherapy and cisplatin (or carboplatin) for twelve months. |
| SoC (chemotherapy and platinum agent) | Active comparator | Drug: SoC (chemotherapy and platinum agent)Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve 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 EGFR diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastatic NSCLC, 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: ZADAXINPatients will be randomized to Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed. | Drug | Thymalfasin (Thymosin alpha 1, Ta1) |
| SoC (chemotherapy and platinum agent)Also: Pemetrexed, carboplatin or cisplatinPatients will be randomized to SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed. | Drug | SoC (chemotherapy and platinum agent), Thymalfasin (Thymosin alpha 1, Ta1) |
Primary outcome
Time to progression free survival (PFS)
Time frame: Up to 12 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.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymalfasin (Thymosin alpha 1, Ta1) and SoC (chemotherapy and platinum agent) in people with Non-Small Cell Lung Cancer, run by SciClone Pharmaceuticals at 8 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 8 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 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?
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?
Time to progression free survival (PFS) (time frame: Up to 12 months). 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.