Neuroendocrine TumorsPhase 2PELICANNCT06232564
A Study of Etoposide-carboplatin in Combination With Pembrolizumab and Lenvatinib Maintenance in HG-NETs
A Phase 2 study testing Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in people with Neuroendocrine Tumors, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2024to 15 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- In order to be eligible for participation in this trial, the participant must:
- Be willing and able to provide written informed consent for the trial.
- Be 18 years or above of age on day of signing informed consent.
- ECOG performance status of 0-2.
- Have histologically or cytologically confirmed diagnosis of poorly differentiated neuroendocrine carcinoma.
- Have Ki-67 labelling index >20% and/or >20 mitoses/10 high-power fields.
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- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have had no prior systemic treatment in the metastatic setting.
- Demonstrate adequate organ function.
- Female subject of childbearing potential should have a negative urine or serum pregnancy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Women of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 120 days after the last dose of Investigational Medicinal Product (IMP).
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Sexually active males must agree to use an adequate method of contraception starting with the first dose of IMP through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Who cannot join
- The participant must be excluded from participating in the trial if the participant:
- Has a diagnosis of large cell and small cell histology of lung origin or Merkel cell carcinoma.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease and stereotactic radiotherapy to the CNS.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
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- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA detectable levels) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a known history of active Bacillus Tuberculosis (TB).
- Has a known history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has a known history of interstitial of lung disease.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication.
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug.
- Bleeding or thrombotic disorders or subjects at risk for severe haemorrhage. The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
- Subjects having >1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is <1 g/24 hours.
- Is currently participating and receiving therapy or has participated or is participating in a study of an IMP or used an investigational device within 4 weeks of the first dose of IMP.
- Has had major surgery within 3 weeks prior to first dose of study treatment.
- Has a history of hypersensitivity to pembrolizumab, lenvatinib, carboplatin, etoposide or any of their excipients.
- Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Principal Investigator (PI).
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through to 120 days after the last dose of IMP.
- Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent.
- Has received a live vaccine within 30 days of first dose of IMP administration. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: PELICAN: a Phase II Study of Etoposide-carboplatin Chemotherapy in Combination With Pembrolizumab and Lenvatinib Maintenance in Advanced High-grade Neuroendocrine Tumours (HG-NETs)
This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants.
Read the detailed description
This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants.
Patients who satisfy study inclusion criteria will be offered the possibility of participating in the study. A patient information sheet and a written consent form will be offered to every patient. Informed consent must be obtained prior to initiation of any clinical screening procedure that is performed solely for the purpose of determining eligibility for research.
Investigators must ensure that subjects are clearly and fully informed about the purpose of the study, in which they volunteer to participate. In situations where consent cannot be given to subjects, their legally acceptable representatives are clearly and fully informed about the purpose, the subject volunteers to participate. The consent form which will include all elements required by ICH, GCP and applicable regulatory, and will adhere to the ethical principles that have their origin in the Declaration of Helsinki.
Following written content, investigators will assess:
- Patient's Demographics and Medical History;
- Patient's Eligibility Confirmation;
The treatment schedule recognizes an induction phase and a maintenance phase.
Induction Phase. Following informed consent and screening investigations (28 days window) patients will receive 4 cycles of induction chemotherapy with carboplatin (AUC 5mg/ml/min) administered IV alongside etoposide (120 mg/m2) and pembrolizumab (200 mg IV) on day 1 of a 21-days cycle, followed by oral etoposide (100 mg twice daily) on day 2-3 of each cycle.
Maintenance Phase. In patients who achieve a complete, partial response or stable disease following induction, maintenance pembrolizumab (200 mg IV on day 1 every 21 days) and lenvatinib (20 mg PO daily) will start following completion of induction treatment and will continue until unacceptable toxicity, disease progression, withdrawal of consent or completion of 2 years of treatment. In days when Lenvatinib is co-administered with pembrolizumab, lenvatinib should be administered prior to pembrolizumab, ideally in the morning of the study visit. Re-staging by computerised tomography (CT) will be performed 21 days after completion of induction then 9-weekly until study completion. A second, optional tumour biopsy will be taken at C3 Day 1 (+/- 14 days).
- Conditions
- Neuroendocrine Tumors
- Being tested
- Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy
- Keywords
- HG-NETs
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapyCombination product
Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy
| Study group | Role | What they receive |
|---|---|---|
| Open Label, Single Arm, Phase II Study | Experimental | This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants. Receives: Combination Product: Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effects of carboplatin, etoposide and pembrolizumab followed by pembrolizumab and lenvantinib maintenance in treatment naïve HG-NETs as measured by RECIST v1.1 criteria.
To evaluate overall response rates (ORR) as measured by RECIST v1.1 criteria.
Measured: 2 Years
Secondary outcomes (1)
Investigation of adverse events from treatment of carboplatin, etoposide and pembrolizumab followed by pembrolizumab and lenvatinib maintenence.
To evaluate incidence of adverse events of any grade attributable to any of the systemic therapies utilised described according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for adverse event reporting. (http://ctep.cancer.gov/reporting/ctc.html).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start8 Jul 2024
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Model description
- Open Label, Single Arm
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232564
- Sponsor's protocol ID
- 1004397
- Acronym
- PELICAN
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PELICAN: a Phase II Study of Etoposide-carboplatin Chemotherapy in Combination With Pembrolizumab and Lenvatinib Maintenance in Advanced High-grade Neuroendocrine Tumours (HG-NETs)
- ClinicalTrials.gov ID
- NCT06232564
- Acronym / sponsor ID
- PELICAN / 1004397
- Conditions
- Neuroendocrine Tumors
- Keywords
- HG-NETs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 30 Jan 2024 (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.
This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants.
Detailed description
This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants.
Patients who satisfy study inclusion criteria will be offered the possibility of participating in the study. A patient information sheet and a written consent form will be offered to every patient. Informed consent must be obtained prior to initiation of any clinical screening procedure that is performed solely for the purpose of determining eligibility for research.
Investigators must ensure that subjects are clearly and fully informed about the purpose of the study, in which they volunteer to participate. In situations where consent cannot be given to subjects, their legally acceptable representatives are clearly and fully informed about the purpose, the subject volunteers to participate. The consent form which will include all elements required by ICH, GCP and applicable regulatory, and will adhere to the ethical principles that have their origin in the Declaration of Helsinki.
Following written content, investigators will assess:
- Patient's Demographics and Medical History;
- Patient's Eligibility Confirmation;
The treatment schedule recognizes an induction phase and a maintenance phase.
Induction Phase. Following informed consent and screening investigations (28 days window) patients will receive 4 cycles of induction chemotherapy with carboplatin (AUC 5mg/ml/min) administered IV alongside etoposide (120 mg/m2) and pembrolizumab (200 mg IV) on day 1 of a 21-days cycle, followed by oral etoposide (100 mg twice daily) on day 2-3 of each cycle.
Maintenance Phase. In patients who achieve a complete, partial response or stable disease following induction, maintenance pembrolizumab (200 mg IV on day 1 every 21 days) and lenvatinib (20 mg PO daily) will start following completion of induction treatment and will continue until unacceptable toxicity, disease progression, withdrawal of consent or completion of 2 years of treatment. In days when Lenvatinib is co-administered with pembrolizumab, lenvatinib should be administered prior to pembrolizumab, ideally in the morning of the study visit. Re-staging by computerised tomography (CT) will be performed 21 days after completion of induction then 9-weekly until study completion. A second, optional tumour biopsy will be taken at C3 Day 1 (+/- 14 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label, Single Arm
| Arm | Type | Receives |
|---|---|---|
| Open Label, Single Arm, Phase II Study | Experimental | Combination Product: Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapyThis is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be willing and able to provide written informed consent for the trial.
- Be 18 years or above of age on day of signing informed consent.
- ECOG performance status of 0-2.
- Have histologically or cytologically confirmed diagnosis of poorly differentiated neuroendocrine carcinoma.
- Have Ki-67 labelling index >20% and/or >20 mitoses/10 high-power fields.
Key exclusion criteria (25 listed)
- Has a diagnosis of large cell and small cell histology of lung origin or Merkel cell carcinoma.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease and stereotactic radiotherapy to the CNS.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
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 |
|---|---|---|
| Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapyPembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy | Combination product | Open Label, Single Arm, Phase II Study |
Primary outcome
Evaluation of the effects of carboplatin, etoposide and pembrolizumab followed by pembrolizumab and lenvantinib maintenance in treatment naïve HG-NETs as measured by RECIST v1.1 criteria.
Time frame: 2 Years
To evaluate overall response rates (ORR) as measured by RECIST v1.1 criteria.
1 secondary outcome
Investigation of adverse events from treatment of carboplatin, etoposide and pembrolizumab followed by pembrolizumab and lenvatinib maintenence.
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in people with Neuroendocrine Tumors, run by Imperial College London at 1 site in United Kingdom.
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 25 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluation of the effects of carboplatin, etoposide and pembrolizumab followed by pembrolizumab and lenvantinib maintenance in treatment naïve HG-NETs as measured by RECIST v1.1 criteria. (time frame: 2 Years). 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 NCT06232564, 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 14 Jan 2026.