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Small Cell Lung Cancer Extensive StagePhase 2PEERSNCT05384015

Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer

A Phase 2 study testing Lenvatinib, Pembrolizumab and Etoposide in people with Small Cell Lung Cancer Extensive Stage, run by Fundación GECP at 18 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multicenter, open-label, non-randomized, single arm, 2 parts, phase II clinical trial evaluating the efficacy and safety of pembrolizumab and lenvatinib plus standard of care chemotherapy (with carboplatin and etoposide ) in subjects with histologically confirmed extensive-stage small-cell lung cancer who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer Extensive Stage
What is being tested?
Lenvatinib, Pembrolizumab and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
18 sitesSpain
Study dates
7 Nov 2022to 30 Dec 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

  • 1. Histologically or cytologically documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration.
  • Note: Subjects who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample. Mixed tumors are not eligible.
  • 2. ES-SCLC, stage IV disease by the American Joint Committee on Cancer, 8th Edition criteria (70), [T any, N any, M1a, M1b, M1c], or T3-4 due to multiple lung nodules that are too extensive or tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
  • 3. Have at least one lesion that meets criteria for being measurable, as defined by RECIST 1.1.
  • 4. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for biomarker assessment.
  • 5. Be male or female ≥18 years of age inclusive, on the day of signing informed consent.
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  • 6. Have a life expectancy of at least 3 months from the study start.
  • 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days prior to the first dose of study intervention.
  • 8. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib placebo and up to 180 days after the last dose of chemotherapeutic agents:
  • Refrain from donating sperm
  • PLUS either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
  • Must agree to use contraception unless confirmed to be azoospermic.
  • 9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a WOCBP OR
  • Is a WOCBP and using a contraceptive method that is highly effective
  • 10. Have voluntarily agreed to participate by giving written consent for the study prior to any specific protocol procedures.
  • 11. Have adequate organ function

Who cannot join

  • 1. Has received any prior therapy (chemotherapy, radiotherapy, surgical resection) or other investigational agent for the treatment of SCLC.
  • 2. Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy while on study.
  • 3. Active CNS metastases and/or carcinomatous meningitis as determined per CT or MRI during screening. Participants with previously treated brain metastases (eg, whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent) may participate only if they satisfy the following:
  • Completed treatment at least 14 days prior to the first dose of study intervention.
  • Are clinically stable, without requirement of steroid treatment for at least 7 days prior to first dose of study intervention.
  • Are radiologically stable.
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  • Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to enrollment, if all other criteria are met.
  • 4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • 5. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to enrollment.
  • 6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
  • 7. .Has known history of, or active, neurologic paraneoplastic syndrome of autoimmune nature.
  • 8. Radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy.
  • 9. Has had major surgery within 4 weeks prior to first dose of study interventions.
  • 10. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of trial drug.
  • 11. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
  • 12. Has an active autoimmune disease or inflammatory disorder that has required systemic treatment in the past 2 years.
  • 13. Has a diagnosis of immunodeficiency or is taking chronic systemic steroid therapy (in dosing of >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • 14. Has known history of a second malignancy other than SCLC, unless potentially curative treatment has been completed with no evidence of malignancy for at least 3 years since the initiation of that therapy.
  • 15. Poor controlled hypertension (BP>150/90 mmHg) despite appropriate treatment.
  • 16. Participants with proteinuria >1+ on urine dipstick testing/urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 g/24 hours will be ineligible.
  • 17. Has a prolongation of QTc interval (calculated using Fridericia's formula) of >480 msec.
  • 18. Has a known history of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • 19. Uncontrolled intercurrent active infection at the time of enrollment requiring systemic therapy.
  • 20. Has a known history of Human Immunodeficiency Virus (HIV) infection.
  • 21. Has a known history of Hepatitis B or known active Hepatitis C.
  • 22. Has a known history of active tuberculosis.
  • 23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study.
  • 24. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • 25. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
  • 26. Prior allogeneic bone marrow transplantation or solid organ transplant.
  • 27. Any gastrointestinal condition that would affect the absorption of Lenvatinib.
  • 28. Has active hemoptysis or major arterial thromboembolic event within 2 weeks prior to the first dose of study intervention.
  • 29. Has significant cardiovascular impairment within 12 months prior to the first dose of study intervention.
  • 30. Has a history of a severe (Grade ≥ 3) hypersensitivity reaction to treatment with another monoclonal antibody or has a known hypersensitivity to lenvatinib, pembrolizumab, carboplatin or etoposide and/or any of its excipients.
  • 31. Has a clinically active diverticulitis, inflammatory bowel disease, intra-abdominal abscess, gastrointestinal obstruction and/or abdominal carcinomatosis.
  • 32. Has a history of a gastrointestinal perforation within 6 months before the first dose of study intervention.
  • 33. Has preexisting Grade ≥ 3 gastrointestinal or non-gastrointestinal fistula.
  • 34. Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention.
  • 35. Has any major hemorrhage or venous thromboembolic events within 3 months before the first dose of study intervention.
  • 36. Poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Spain18 sites

  • Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clínic De Barcelona

    Barcelona, Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

  • Hospital Parc Taulí

    Barcelona, Barcelona, 08208

  • Hospital De Basurto

    Bilbao, Bilbao, 48013

  • ICO Girona, Hospital Josep Trueta

    Girona, Girona, 17007

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital 12 De Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Universitario Regional de Málaga

    Málaga, Málaga, 29010

  • Hospital Son Espases

    Palma de Mallorca, Palma de Mallorca, 07120

  • Complejo Hospitalario de Navarra

    Pamplona, Pamplona, 31008

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

Other trials in Spain

About this study

Official title: A Phase II Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer (ES-SCLC)

This is a multicenter, open-label, non-randomized, single arm, 2 parts, phase II clinical trial evaluating the efficacy and safety of pembrolizumab and lenvatinib plus standard of care chemotherapy (with carboplatin and etoposide ) in subjects with histologically confirmed extensive-stage small-cell lung cancer who have not previously received systemic therapy for this malignancy.

Read the detailed description

A total of 85 subjects will be assigned to study treatment with pembrolizumab + lenvatinib + chemotherapy. Positive tumor programmed cell death-ligand 1 (PD-L1) expression will not be required for enrollment; however, subjects' tumors will be screened for PD-L1 expression.

The primary endpoint for the Part 1 is to determine the safety of the combination. The primary endpoint for Part 2 is to determine the Progression Free survival (PFS) using RECIST 1.1. assessed by investigator.

The sponsor estimates that the trial will require approximately 4 years from the time the first participant signs the informed consent until the last participant's last study-related telephone call or visit (2 years recruiting patients, 1 year of treatment and at least 1 year of follow up)

Keywords
Lenvatinib, Pembrolizumab, Lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • LenvatinibDrug

    Also called LENVIMA, KISPLYX

    Lenvatinib is an oral, potent multiple receptor tyrosine kinase (RTK) i that selectively inhibits VEGF-driven VEGFR2 phosphorylation and suppressed proliferation and tube formation in human umbilical vein endothelial cell models. Antitumor activity of lenvatinib in vivo has been shown in numerous xenograft animals. These results suggest that lenvatinib may be a novel anticancer therapy through inhibition of angiogenesis and may be useful as either monotherapy or in combination with other anticancer drugs.

    Part 1 (safety run-in) and Part 2:

    The study intervention consists of:

    Dose: 8 mg (induction) and 20 mg (maintenance) Dose Frequency: Once daily Dose formulation: Capsule Route of administration: Oral Treatment duration: 4 cycles (induction) and no treatment duration limit (maintenance).

  • PembrolizumabDrug

    Also called KEYTRUDA

    Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).

    Part 1 (safety run-in) and Part 2:

    Dose: 200 mg Frequency: Day 1, Q3W Route: Intravenous Treatment Period: Up to 35 cycles or until reaching a discontinuation criterion

  • EtoposideDrug

    Also called Etoposide Tevagen

    Standard first-line treatment for the vast majority of patients with SCLC, regardless of stage, involves combination chemotherapy with etoposide plus cisplatin or carboplatin.

    Pharmacotherapeutic group: Cytostatics, plant alkaloids and other natural products, derived from podophyllotoxin. Mechanism of action :The main effect of etoposide appears to be in the late S and early G2 phase of the cell cycle, in mammalian cells.

    Part 1 (safety run-in) and Part 2:

    Dose: 100 mg/m2 Frequency: Day 1-3, Q3W Route: Intravenous Treatment Period: 4 cycles

  • CarboplatinDrug

    Also called Carboplatin Accord

    Pharmacotherapeutic group: Other antineoplastic agents, platinum compounds.

    Carboplatin, like cisplatin, binds to DNA to produce inter- and intra-strand cross-links cells exposed to carboplatin. DNA reactivity has been linked to cytotoxicity.

    Part 1 (safety run-in) and Part 2:

    Dose: AUC5 Frequency: Day 1, Q3W Route: Intravenous Treatment Period: 4 cycles

Study groups in NCT05384015
Study groupRoleWhat they receive
ExperimentalExperimentalTrial Treatment administration: at induction phase cycles will be administered every 3 weeks. For carboplatin (AUC5) and etoposide (100mg/m2) the maximum dose exposure will be 4 cycles or until reaching a discontinuation criterion. At this induction phase lenvatinib (8mg) will be orally administered daily and pembrolizumab (200mg) IV every 3 weeks. At maintenance phase lenvatinib will be administered at 20 mg dose and pembrolizumab at the same dose (200mg) until study intervention completion (total of 35 cycles of pembrolizumab/no treatment duration limit for lenvatinib) or reaching a discontinuation criterion.
Receives: Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Etoposide; Drug: Carboplatin

What is being measured

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

  1. Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of lenvatinib 8 mg to be used in combination with pembrolizumab plus chemotherapy

    Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

    Measured: From the subject's written consent to participate in the study through 90 days after the final administration of the drug

  2. Part 2:To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS)

    PFS is defined as the time from enrollment to the date of the first documentation of disease progression, as determined by investigator per RECIST 1.1, or death from any cause, whichever is earlier.

    Measured: From the date of the end of induction treatment until 12 months

Secondary outcomes (7)

  1. Part 1 (for patients treated at part 2): Objective response per RECIST 1.1 based on investigator

    Objective response is a confirmed complete response (CR) or partial response (PR), as determined by investigator per RECIST 1.1.

    Measured: From the date of the end of treatment until 12 months

  2. Part 1 (for patients treated at part 2): Duration of Response (DOR) per RECIST 1.1 based on investigator

    DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause (whichever is earlier), for participants who demonstrate a confirmed CR or PR. Response will be determined by BICR per RECIST 1.1.

    Measured: From date of documentation of tumor response until date of first documented progression, assessed up to 12 months

  3. Part 1 (for patients treated at part 2): Overall Survival

    OS is defined as the time from enrollment to the date of death from any cause.

    Measured: From the date of the end of treatment until 12 months

  4. Part 2: Objective response per RECIST 1.1 based on investigator

    Objective response is a confirmed complete response (CR) or partial response (PR), as determined by investigator per RECIST 1.1.

    Measured: From the date of the end of treatment until 12 months

  5. Part 2: Duration of Response (DOR) per RECIST 1.1 based on investigator

    DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause (whichever is earlier), for participants who demonstrate a confirmed CR or PR. Response will be determined by BICR per RECIST 1.1.

    Measured: From date of documentation of tumor response until date of first documented progression, assessed up to 12 months

  6. Part 2:Overall Survival

    OS is defined as the time from enrollment to the date of death from any cause.

    Measured: From the date of the end of treatment until 12 months

  7. Part 2: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of treatment

    Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0

    Measured: From the subject's written consent to participate in the study through 90 days after the final administration of the drug

Timeline

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

  1. First posted20 May 2022
  2. Study start7 Nov 2022
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Dec 2027 (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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384015
Sponsor's protocol ID
GECP 20/06_PEERS
Other IDs
2020-005230-15
Acronym
PEERS
Status last verified
Apr 2026
First submitted
17 May 2022
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib, Pembrolizumab and Etoposide in people with Small Cell Lung Cancer Extensive Stage, run by Fundación GECP at 18 sites in Spain.

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 18 inclusion and 40 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain. 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?

Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of lenvatinib 8 mg to be used in combination with pembrolizumab plus chemotherapy (time frame: From the subject's written consent to participate in the study through 90 days after the final administration of the drug). 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?

On the ClinicalTrials.gov record for NCT05384015.

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 Apr 2026.

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