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Small Cell Lung CancerPhase 2NabsterNCT03219762

Study of Nab-paclitaxel in Sensitive and Refractory Relapsed SCLC

A Phase 2 study testing Nabpaclitaxel in people with Small Cell Lung Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 26 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Evaluate the activity and safety of Nab-paclitaxel in patients with sensitive or refractory SCLC who relapsed after cisplatin or carboplatin and etoposide first-line chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Nabpaclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
26 sitesItaly
Study dates
7 Feb 2017to Jan 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

  • Pathologically (histology or cytology) confirmed diagnosis of small cell lung cancer (SCLC) or large-cell neuroendocrine carcinoma (LCNEC) or poorly differentiated (G3) neuroendocrine cancer of the lung (according to WHO classification 2015)
  • Male or female and ≥ 18 years of age
  • Life expectancy ≥ 12 weeks
  • Have progressed after or during platinum-based standard chemotherapy regimen (cisplatin or carboplatin and etoposide) for first-line treatment of SCLC, either limited stage (LD) or extensive stage (ED) disease and have not received any other treatment (except for immunotherapy as maintenance treatment), including re-treatment with front-line regimen
  • Have measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1); clear radiological evidence of disease progression after first-line therapy has to be documented; no previous radiotherapy on the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Show all 19Show fewer
  • Patients with treated brain metastases with stable lesions for at least 2 weeks and off steroids or on a stable dose of steroids. Radiotherapy must have been completed a minimum of 14 days prior to registration, and patients must have recovered from AEs related to radiotherapy to < grade 1 (except alopecia)
  • For Females: must be postmenopausal (defined as occurring 12 months after last menstrual period) before the screening visit, or are surgically sterile. If they are of childbearing potential, a negative serum pregnancy test prior to study entry has to be documented; furthermore, they agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 30 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
  • For Males: even if surgically sterilized (i.e. post-vasectomy status) agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
  • Screening clinical laboratory values as specified below:
  • Absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm3 and haemoglobin ≥ 9 g/dL
  • Total bilirubin < 1.5 the institutional upper limit of normal (ULN)
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 the institutional ULN (< 5 if liver function test elevations are due to liver metastases)
  • Creatinine < 1.5 institutional ULN or estimated creatinine clearance using the Cockcroft-Gault formula ≥ 30 mL/minute for patients with creatinine levels above institutional limits
  • Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion/exclusion criteria
  • Recovered (i.e., ≤ Grade 1 toxicity) from effects of prior anticancer therapy, except alopecia
  • Prior radiotherapy is allowed provided that it has been completed more than 2 weeks before starting Nab-paclitaxel
  • Ability to comply with protocol requirements
  • The patient or the patient's legal representative has to be able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Who cannot join

  • Any prior not platinum-based chemotherapy treatment for SCLC or large-cell neuroendocrine carcinoma (LCNEC) or poorly differentiated (G3) neuroendocrine cancer of the lung (according WHO classification 2015) (immunotherapy is allowed as maintenance treatment)
  • Prior treatment with Nab-paclitaxel, paclitaxel or any other taxane agent
  • Known hypersensitivity to Cremophor EL®, paclitaxel, or its components
  • Any comorbid condition or unresolved toxicity that would preclude administration of weekly Nab-paclitaxel
  • Prior history of Grade ≥ 2 neurotoxicity that is not resolved to ≤ Grade 1
  • Patients with symptomatic and/or progressive brain metastases or with carcinomatous meningitis
Show all 12Show fewer
  • Diagnosed with or treated for another malignancy within 3 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type may be enrolled in the study if they have undergone complete resection and no evidence of active disease is present
  • History of myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, any ongoing cardiac arrhythmias of Grade > 2, thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (egg, pericardial effusion or restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. Patients with a pacemaker may be enrolled in the study upon discussion with the project clinician
  • Infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug
  • For female subjects: positive serum pregnancy test, pregnancy or breast feeding
  • Surgery within 3 weeks (or 2 weeks for a minor surgery) before study enrolment and not fully recovered to baseline or to a stable clinical status. Insertion of a vascular device is allowed
  • Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel

Trial locations and contacts

26 sites in 1 country.

GOIRC contact

00390512142204

nabsterstudy@gmail.com

Andrea Ardizzoni, PI contact

00390512142204

andrea.adizzoni@aosp.bo.it

26 sites in 1 country

Italy26 sites, 26 recruiting

  • SC Oncologia - ASO "SS Antonio e Biagio e Cesare Arrigo,Alessandria

    Alessandria, 15121

    Perluigi Piovano

    Not yet recruiting

  • Cliniche Humanitas Gavazzeni

    Bergamo, 24125

    Giovanni Luca Ceresoli

    Not yet recruiting

  • Oncologia Medica, Ospedale Papa Giovanni XXIII

    Bergamo, 24127

    Anna Bettini, MD

    Recruiting

  • UO di Oncologia Medica, Azienda Ospedaliero-Universitaria S. Orsola Malpighi di Bologna,

    Bologna, 40138

    Andrea Ardizzoni, MD

    Recruiting

  • Divisione di Oncologia Medica - Ospedale di Bolzano,

    Bolzano, 39100

    Emanuela Vattemi, MD

    Recruiting

  • UOC Oncologia Medica PO A.Perino ASL di Brindisi

    Brindisi, 72100

    Saverio Cinieri, MD

    Recruiting

  • UO Medicina Oncologica Ospedale di Carpi (MO)

    Carpi, Modena, 41012

    Lucia Longo, MD

    Recruiting

  • UO di Oncologia Ematologia, Azienda Ospedaliero Universitaria di Ferrara

    Cona, Ferrara, 44124

    Antonio Frassoldati, MD

    Recruiting

  • SC di Oncologia, Istituti Ospitalieri di Cremona

    Cremona, 26100

    Matteo Brighenti, MD

    Not yet recruiting

  • Dipartimento di Oncologia Medica A.O. Santa Croce e Carle Ospedale Carle

    Cuneo, 12100

    Ida Colantonio, MD

    Recruiting

  • Azienda Ospedaliera Careggi, UO di Oncologia Medica

    Florence, 50139

    Francesco Di Costanzo, MD

    Not yet recruiting

  • UOC Oncologia, Azienda USL di Imola, Ospedale Santa Maria della Scaletta

    Imola, 40028

    Antonio Maestri, MD

    Not yet recruiting

  • UOC Oncologia Medica, Azienda ULSS21 di Legnago

    Legnago, Verona, 37045

    Andrea Bonetti, MD

    Not yet recruiting

  • Oncologia Medica - Ospedale Versilia

    Lido di Camaiore, Lucca, 55043

    Andrea Camerini, MD

    Not yet recruiting

  • Dipartimento Oncologico, Azienda USL 2 di Lucca, Ospedale San Luca

    Lucca, 55100

    Carmelo Tibaldi, MD

    Not yet recruiting

  • Oncologia Medica, IRST. Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori, IRCCS di Meldola

    Meldola, Forlì-Cesena, 47014

    Angelo Del Monte, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia

    Modena, 41100

    Fausto Barbieri, MD

    Recruiting

  • SC di Oncologia Medica, A.O. San Gerardo di Monza

    Monza, MB, 20900

    Diego Cortinovis, MD

    Not yet recruiting

  • S. C. di Oncologia Medica AORN "Antonio Cardarelli"

    Naples, 80131

    Ferdinando Riccardi, MD

    Not yet recruiting

  • Oncologia Medica, Ospedale Sacro Cuore - Don Calabria - Negrar (VR)

    Negrar, Verona, 37024

    Stefania Gori, MD

    Not yet recruiting

  • UOC di Oncologia Medica di Parma, Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

    Marcello Tiseo, MD

    Not yet recruiting

  • Dipartimento di Oncologia e Ematologia, UO di Oncologia Medica Azienda USL di Piacenza

    Piacenza, 29121

    Luigi Cavanna, MD

    Recruiting

  • Dipartimento di Oncologia Ematologia. UO di Oncologia Medica, AUSL della Romagna, Ospedale Santa Maria delle Croci di Ravenna

    Ravenna, 48121

    Claudio Dazzi, MD

    Recruiting

  • Sezione Pneumo-Oncologica - Medicina Interna I; IRCCS "Casa Sollievo della Sofferenza"

    San Giovanni Rotondo, Foggia, 71013

    Vito D'Alessandro, MD

    Not yet recruiting

  • UOC di Oncologia Medica - Ospedale di Saronno

    Saronno, Varese, 21047

    Claudio Verusio, MD

    Not yet recruiting

  • Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica

    Torino, 10126

    Libero Ciuffreda, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: Phase II Study of Nab-paclitaxel in Sensitive and Refractory Relapsed Small Cell Lung Cancer (Nabster Study)

Evaluate the activity and safety of Nab-paclitaxel in patients with sensitive or refractory SCLC who relapsed after cisplatin or carboplatin and etoposide first-line chemotherapy.

Read the detailed description

Phase II study of NAB-paclitaxel in SensiTivE and Refractory relapsed SCLC

Being tested
Nabpaclitaxel
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NabpaclitaxelDrug

    Also called Abraxane

    Chemotherapy will be continued until a maximum of 6 courses or progressive disease or intolerable toxicity or patient refusal. In patients with confirmed and prolonged disease response, clinical benefit and good tolerance to study drug treatment, the investigators can evaluate to continue therapy beyond 6th cycle, after discussion with Principal Investigator (PI) of the study

Study groups in NCT03219762
Study groupRoleWhat they receive
Nab-paclitaxelExperimentalNab-paclitaxel (30-min infusion) 100 mg/sqm weekly on days 1, 8, 15 q 28 days.
Receives: Drug: Nabpaclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary end-point is objective tumor response

    It will be evaluated according to standard RECIST 1.1 criteria and will be based on the Investigator's assessment.

    Measured: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 weeks.

Secondary outcomes (3)

  1. Frequency of Toxicity Events: frequency of moderate and severe toxicity events and drop-out rate due to therapy related toxicity

    The assessment of safety will be based mainly on the frequency of adverse events. Adverse events will be summarized by presenting the number and percentage of patients having any adverse event, having an adverse event in each body system and having each individual adverse event.

    Toxicity descriptive tables will be produced which provide the worst degree of toxicity measured over all cycles according to the CTCAE version 4.03

    Measured: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 weeks.

  2. Progression Free Survival (PFS)

    will be calculated from the patient registration to the evidence of progressive disease, or death, or the last date the patient was known to be progression-free or alive.

    Measured: From date of registration until the date of last documented progression or date of death from any cause, assessed up to 100 weeks

  3. Overall Survival (OS)

    will be calculated from the registration to death from any cause, or the last date the patient was known to be alive from the registration to death from any cause, or the last date the patient was known to be alive

    Measured: From date of patient enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start7 Feb 2017
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, multicentre, study
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03219762
Sponsor's protocol ID
GOIRC-02-2016
Acronym
Nabster
Status last verified
Jul 2017
First submitted
24 Mar 2017
Last updated
26 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gelsomino F, Tiseo M, Barbieri F, Riccardi F, Cavanna L, Frassoldati A, Delmonte A, Longo L, Dazzi C, Cinieri S, Colantonio I, Sperandi F, Lamberti G, Brocchi S, Tofani L, Boni L, Ardizzoni A. Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL). Br J Cancer. 2020 Jul;123(1):26-32. doi: 10.1038/s41416-020-0845-3. Epub 2020 Apr 29.

    PubMed 32346071

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nabpaclitaxel in people with Small Cell Lung Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 26 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 19 inclusion and 12 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 GOIRC (00390512142204, nabsterstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary end-point is objective tumor response (time frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03219762, which also lists 1 linked publication.

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 26 Jul 2017.

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