OncologyPhase 2NET02NCT03837977

Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma

A Phase 2 study testing Liposomal Irinotecan, Fluorouracil and Folinic Acid in people with Oncology and Neuroendocrine Carcinoma, run by The Christie NHS Foundation Trust at 4 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

There is currently no standard treatment beyond first-line etoposide/platinum-based chemotherapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma. Therefore the treatment of patients whose disease progresses on or after this first-line treatment is an area of unmet need. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oncology, Neuroendocrine Carcinoma
What is being tested?: Liposomal Irinotecan, Fluorouracil and Folinic Acid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 4 sitesUnited Kingdom
Study dates: 13 Nov 2018to 26 Nov 2024
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 and life expectancy ≥3 months.
Diagnosed with poorly differentiated (as defined by the World Health Organisation in 2010, Ki 67 ≥20%) extra-pulmonary neuroendocrine carcinoma (NEC grade 3, confirmed by histology). (Carcinoma of unknown primary is allowed if lung primary has been excluded following review by the multi-disciplinary team).
Prior treatment with first-line platinum-based chemotherapy for NEC in the advanced setting and ≥28 days from Day 1 of the previous treatment cycle.
Documented radiological evidence of disease progression OR discontinuation of first-line platinum-based chemotherapy due to intolerance.
Measurable disease according to RECIST 1.1
Eastern Co-operative Oncology Group (ECOG) performance status ≤2

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Adequate renal function with serum creatinine ≤1.5 times upper limit of normal (ULN) and creatinine clearance ≥50ml30ml/min according to Cockroft-Gault or Wright formula. If the calculated creatinine clearance is less than 30 ml/min, glomerular filtration rate (GFR) may be assessed using either Cr51-EDTA or 99mTc-DTPA clearance method to confirm if GFR is ≥30 ml/min).
Adequate haematological function: Hb ≥90g/L, WBC ≥3.0 x 109/L, ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L.
Adequate liver function: serum total bilirubin 1.5 x ULN (biliary drainage is allowed for biliary obstruction) and ALT and/or AST 2.5 x ULN in the absence of liver metastases, or 5 x ULN in the presence of liver metastases.
A negative pregnancy test is required at registration in women of childbearing potential.
Men and women of reproductive potential must agree to use a highly effective form of contraception during the study and for 6 months following the last dose of trial treatment. In addition, male participants should use a condom during study participation and for 6 months following the last dose of trial treatment.
Patients must be able to provide written informed consent.
Patients must be able and willing to comply with the terms of the protocol.

Who cannot join

Known or suspected allergy or hypersensitivity reaction to any of the components of study treatment or their excipients.
Use (including self-medication) within one week of randomisation and for the duration of the study of any of the following: St. John's wort, grapefruit, Seville oranges, medicines known to inhibit UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) and medicines known to inhibit or induce either CYP3A4 or CYP3A5
Previous treatment (for neuroendocrine carcinoma) with any of the components of combination chemotherapy regimens detailed in this study (nal-IRI or 5-FU or irinotecan or topoisomerase inhibitors or taxane-based therapy).
Incomplete recovery from previous therapy in the opinion of the investigator (surgery/adjuvant therapy/radiotherapy/chemotherapy in advanced setting), including ongoing peripheral neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous platinum-based therapy.
Concurrent palliative radiotherapy involving target lesions used for this study (<28 days from discontinuation of radiotherapy). Radiotherapy for non-target lesions is allowed if other target lesions are available outside the involved field.
Patients must not have a history of other malignant diseases (within the previous 3 years, and there must be no evidence of recurrence), other than:

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Extra-pulmonary neuroendocrine carcinoma.
Non-melanoma skin cancer where treatment consisted of resection only or radiotherapy.
Ductal carcinoma in situ (DCIS) where treatment consisted of resection only.
Cervical carcinoma in situ where treatment consisted of resection only.
Superficial bladder carcinoma where treatment consisted of resection only.
Documented brain metastases, unless adequately treated (surgery or radiotherapy only), with no evidence of progression and neurologically stable off anticonvulsants and steroids.
Clinically significant gastrointestinal disorder (in the opinion of the treating clinician) including hepatic disorders, bleeding, inflammation, obstruction, or diarrhoea ≥CTCAE grade 1 (at time of study entry).
Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.
New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure .
Severe bone marrow failure or bone marrow depression after radiotherapy or treatment with other antineoplastic agents (defined as haematological values of haemoglobin or white blood cells or neutrophils or platelets not meeting inclusion criteria).
Known active hepatitis B virus, hepatitis C virus or HIV infection.
Active chronic inflammatory bowel disease.
Breastfeeding women.
Evidence of severe or uncontrolled systemic diseases which, in the view of the treating clinician, makes it undesirable for the patient to participate in the trial.
Evidence of significant clinical disorder or laboratory finding which, in the opinion of the treating clinician, makes it undesirable for the patient to participate in the trial.
Medical or psychiatric conditions that impair the ability to give informed consent.
Any other serious uncontrolled medical conditions (in the opinion of the treating clinician).

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

The Beaston West of Scotland Cancer Center, NHS Greater Glasgow and Clyde
Glasgow
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London
The Christie NHS Foundation Trust
Manchester, M20 4BX
Weston Park Hospital, Sheffield Teaching Hospitals, NHS Trust
Sheffield

Other trials in United Kingdom

About this study

Official title: A Multi-centre, Randomised, Parallel Group, Open-label, Phase II, Single-stage Selection Trial of Liposomal Irinotecan (Nal-IRI) and 5-fluorouracil (5-FU)/Folinic Acid or Docetaxel as Second-line Therapy in Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma (NEC))

Combination regimens such as irinotecan/5-fluorouracil/folinic acid are a second-line treatment option currently used in Europe and world-wide for this subset of patients. However, there is currently no trial evidence supporting this treatment regimen in these patients.

Results of the NAPOLI-1 phase III trial of liposomal irinotecan in the treatment of patients with metastatic pancreatic adenocarcinoma after gemcitabine-based therapy reported improved survival for those patients who received a combination of liposomal irinotecan with 5-FU/folinic acid compared to those patients who received 5-FU/folinic acid alone. Liposomal irinotecan has been found to show an improved distribution into tumour tissue in comparison to irinotecan, and this may have clinical benefit in patients with extra-pulmonary neuroendocrine carcinoma.

Docetaxel is standardly used as a second-line treatment option in patients with small cell lung cancer who have progressed on primary etoposide-platinum combination therapy. Therefore this drug could also have clinical benefit in patients with extra-pulmonary neuroendocrine carcinoma as the biology of the disease is similar to small cell lung cancer.

The overall aim of the NET-02 trial is to select a treatment for continuation to a Phase III trial. The intention of the trial is to determine whether liposomal irinotecan/5-fluorouracil/folinic acid and docetaxel are sufficiently active in this population of patients. If both treatments are found to be efficacious, selection criteria will be applied to select a treatment to take forward.

102 eligible participants will be randomised to receive either liposomal irinotecan/5-fluorouracil/folinic acid given every 14 days, or docetaxel given every 21 days. Participants will be treated for a minimum of 6 months or until discontinuation of treatment as per protocol.

Conditions: Oncology, Neuroendocrine Carcinoma
Being tested: Liposomal Irinotecan, Fluorouracil, Folinic Acid, Docetaxel
Medical subject headings: Neoplasms, Carcinoma, Neuroendocrine

What participants receive

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

Liposomal IrinotecanDrug
Also called Onivyde
Arm I
FluorouracilDrug
Arm I
Folinic AcidDrug
Arm I
DocetaxelDrug
Arm II

Study groups in NCT03837977
Study group	Role	What they receive
nal-IRI, 5-FU and racemic folinic acid	Active comparator	liposomal Irinotecan (naI-IRI) (80mg/m2 intravenously over 90 minutes (± 10 minutes) prior to Fluorouracil (5-FU) 5-FU 2400 mg /m2 BSA infusor over 46 hours racemic folinic acid (as per local standard practice) every 14 days Receives: Drug: Liposomal Irinotecan; Drug: Fluorouracil; Drug: Folinic Acid
docetaxel	Active comparator	75mg/m*2 intravenously over 60 minutes) every 21 days] Receives: Drug: Docetaxel

What is being measured

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

Progression-free survival defined as a binary outcome (progression-free or not)
Measured: treatment start date until 6 months, assessed at 8 weekly intervals by CT scan

Secondary outcomes (7)

Progression-free survival defined as time from randomisation to progression or death from any cause.
Individuals will be censored if they are lost to follow-up or still alive and progression-free at the time of analysis.
Measured: randomisation until 6 months after the last participant is randomised (end of trial), assessed at 8 weekly intervals by CT scan and death is continuously assessed
Overall survival defined as time from randomisation to death from any cause.
Individuals will be censored if they are lost to follow-up or still alive and progression-free at the time of analysis.
Measured: randomisation until 6 months after the last participant is randomised (end of trial), death is continuously assessed
Objective response rate defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: start of treatment until 6 months after the last participant is randomised (end of trial)
Toxicity defined as the number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE) v5.0.
Measured: treatment start date until 6 months after the last participant is randomised (end of trial), assessed at 2 (nal-IRI/5-FU/folinic acid) or 3 (docetaxel) weekly intervals
Quality of life assessed according to the patient reported outcome measures; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Measured: randomisation until 6 months after the last participant is randomised (end of trial), assessed at 6 weekly intervals
Neuron-specific enolase (NSE) measurements.
Measured: baseline until 6 months after the last participant is randomised (end of trial), assessed at 6 weekly intervals
Quality of life assessed according to the patient reported outcome measures; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) GINET21.
Measured: randomisation until 6 months after the last participant is randomised (end of trial), assessed at 6 weekly intervals

Timeline

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

13 Nov 201826 Nov 2024

First posted12 Feb 2019
Study start13 Nov 2018
Primary completion26 Nov 2024
Study completion26 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for OncologyStudies 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
Model description: The study is a randomised controlled trial. One hundred and two eligible participants will be randomised (1:1)
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03837977
Sponsor's protocol ID: CFTSp116
Acronym: NET02
Status last verified: Dec 2024
First submitted: 27 Sep 2018
Last updated: 30 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance). No individual participant data will be released before an appropriate agreement is in place setting out the conditions of release. The agreement will govern data retention, usually stipulating that data recipients must delete their copy of the released data at the end of the planned project. The CTRU encourages a collaborative approach to data sharing, and believe it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, copies of key trial documents and any other information required to understand and reuse the released datasets.

Publications

McNamara MG, Swain J, Craig Z, Sharma R, Faluyi O, Wadsley J, Morgan C, Wall LR, Chau I, Reed N, Sarker D, Margetts J, Krell D, Cave J, Sothi S, Anthoney A, Bell C, Patel A, Oughton JB, Cairns DA, Mansoor W, Lamarca A, Hubner RA, Valle JW. NET-02: a randomised, non-comparative, phase II trial of nal-IRI/5-FU or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma. EClinicalMedicine. 2023 Jun 2;60:102015. doi: 10.1016/j.eclinm.2023.102015. eCollection 2023 Jun.
PubMed 37287870
Craig Z, Swain J, Batman E, Wadsley J, Reed N, Faluyi O, Cave J, Sharma R, Chau I, Wall L, Lamarca A, Hubner R, Mansoor W, Sarker D, Meyer T, Cairns DA, Howard H, Valle JW, McNamara MG. NET-02 trial protocol: a multicentre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC). BMJ Open. 2020 Feb 5;10(2):e034527. doi: 10.1136/bmjopen-2019-034527.
PubMed 32029495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Randomised, Parallel Group, Open-label, Phase II, Single-stage Selection Trial of Liposomal Irinotecan (Nal-IRI) and 5-fluorouracil (5-FU)/Folinic Acid or Docetaxel as Second-line Therapy in Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma (NEC))
ClinicalTrials.gov ID: NCT03837977
Acronym / sponsor ID: NET02 / CFTSp116
Conditions: Oncology, Neuroendocrine Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: The Christie NHS Foundation TrustUniversity, hospital or other
Collaborators: University of Leeds, Servier, National Institute for Health Research, United Kingdom
Study start: 13 Nov 2018 (actual)
Primary completion: 26 Nov 2024 (actual)
Study completion: 26 Nov 2024 (actual)
First posted: 12 Feb 2019 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The study is a randomised controlled trial. One hundred and two eligible participants will be randomised (1:1)

Arm	Type	Receives
nal-IRI, 5-FU and racemic folinic acid	Active comparator	Drug: Liposomal Irinotecan, Drug: Fluorouracil, Drug: Folinic Acidliposomal Irinotecan (naI-IRI) (80mg/m2 intravenously over 90 minutes (± 10 minutes) prior to Fluorouracil (5-FU) 5-FU 2400 mg /m2 BSA infusor over 46 hours racemic folinic acid (as per local standard practice) every 14 days
docetaxel	Active comparator	Drug: Docetaxel75mg/m*2 intravenously over 60 minutes) every 21 days]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Age ≥18 years and life expectancy ≥3 months.
Diagnosed with poorly differentiated (as defined by the World Health Organisation in 2010, Ki 67 ≥20%) extra-pulmonary neuroendocrine carcinoma (NEC grade 3, confirmed by histology). (Carcinoma of unknown primary is allowed if lung primary has been excluded following review by the multi-disciplinary team).
Prior treatment with first-line platinum-based chemotherapy for NEC in the advanced setting and ≥28 days from Day 1 of the previous treatment cycle.
Documented radiological evidence of disease progression OR discontinuation of first-line platinum-based chemotherapy due to intolerance.
Measurable disease according to RECIST 1.1

Key exclusion criteria (23 listed)

Known or suspected allergy or hypersensitivity reaction to any of the components of study treatment or their excipients.
Use (including self-medication) within one week of randomisation and for the duration of the study of any of the following: St. John's wort, grapefruit, Seville oranges, medicines known to inhibit UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) and medicines known to inhibit or induce either CYP3A4 or CYP3A5
Previous treatment (for neuroendocrine carcinoma) with any of the components of combination chemotherapy regimens detailed in this study (nal-IRI or 5-FU or irinotecan or topoisomerase inhibitors or taxane-based therapy).
Incomplete recovery from previous therapy in the opinion of the investigator (surgery/adjuvant therapy/radiotherapy/chemotherapy in advanced setting), including ongoing peripheral neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous platinum-based therapy.
Concurrent palliative radiotherapy involving target lesions used for this study (<28 days from discontinuation of radiotherapy). Radiotherapy for non-target lesions is allowed if other target lesions are available outside the involved field.

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
Liposomal IrinotecanAlso: OnivydeArm I	Drug	nal-IRI, 5-FU and racemic folinic acid
FluorouracilArm I	Drug	nal-IRI, 5-FU and racemic folinic acid
Folinic AcidArm I	Drug	nal-IRI, 5-FU and racemic folinic acid
DocetaxelArm II	Drug	docetaxel

Primary outcome

Progression-free survival defined as a binary outcome (progression-free or not)
Time frame: treatment start date until 6 months, assessed at 8 weekly intervals by CT scan

7 secondary outcomes

Progression-free survival defined as time from randomisation to progression or death from any cause.
Time frame: randomisation until 6 months after the last participant is randomised (end of trial), assessed at 8 weekly intervals by CT scan and death is continuously assessed
Overall survival defined as time from randomisation to death from any cause.
Time frame: randomisation until 6 months after the last participant is randomised (end of trial), death is continuously assessed
Objective response rate defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: start of treatment until 6 months after the last participant is randomised (end of trial)
Toxicity defined as the number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE) v5.0.
Time frame: treatment start date until 6 months after the last participant is randomised (end of trial), assessed at 2 (nal-IRI/5-FU/folinic acid) or 3 (docetaxel) weekly intervals
Quality of life assessed according to the patient reported outcome measures; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Time frame: randomisation until 6 months after the last participant is randomised (end of trial), assessed at 6 weekly intervals
Neuron-specific enolase (NSE) measurements.
Time frame: baseline until 6 months after the last participant is randomised (end of trial), assessed at 6 weekly intervals
Quality of life assessed according to the patient reported outcome measures; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) GINET21.
Time frame: randomisation until 6 months after the last participant is randomised (end of trial), assessed at 6 weekly intervals

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
Derived from this study: PubMed 37287870McNamara MG, Swain J, Craig Z, Sharma R, Faluyi O, Wadsley J, Morgan C, Wall LR, Chau I, Reed N, Sarker D, Margetts J, Krell D, Cave J, Sothi S, Anthoney A, Bell C, Patel A, Oughton JB, Cairns DA, Mansoor W, Lamarca A, Hubner RA, Valle JW. NET-02: a randomised, non-comparative, phase II trial of nal-IRI/5-FU or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma. EClinicalMedicine. 2023 Jun 2;60:102015. doi: 10.1016/j.eclinm.2023.102015. eCollection 2023 Jun.
Derived from this study: PubMed 32029495Craig Z, Swain J, Batman E, Wadsley J, Reed N, Faluyi O, Cave J, Sharma R, Chau I, Wall L, Lamarca A, Hubner R, Mansoor W, Sarker D, Meyer T, Cairns DA, Howard H, Valle JW, McNamara MG. NET-02 trial protocol: a multicentre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC). BMJ Open. 2020 Feb 5;10(2):e034527. doi: 10.1136/bmjopen-2019-034527.
Individual participant dataSharing planned: Yes. De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance). No individual participant data will be released before an appropriate agreement is in place setting out the conditions of release. The agreement will govern data retention, usually stipulating that data recipients must delete their copy of the released data at the end of the planned project. The CTRU encourages a collaborative approach to data sharing, and believe it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, copies of key trial documents and any other information required to understand and reuse the released datasets.

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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.

Mairead McNamara principal investigator

The Christie NHS Foundation Trust, The University of Manchester

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 23 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 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival defined as a binary outcome (progression-free or not) (time frame: treatment start date until 6 months, assessed at 8 weekly intervals by CT scan). 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 NCT03837977, which also lists 2 linked publications.

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 30 Dec 2024.