AzTrials
AzTrials

Limited Stage Lung Small Cell CarcinomaPhase 2NCT06140407

Pembrolizumab After Radiation Therapy and Chemotherapy in Limited Stage Small Cell Lung Cancer

A Phase 2 study testing Cisplatin, Carboplatin and Etoposide in people with Limited Stage Lung Small Cell Carcinoma and Stage I Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial studies how well pembrolizumab after standard treatment with radiation plus the following chemotherapy drugs: cisplatin or carboplatin, plus etoposide works in treating patients with limited stage small cell lung cancer (LS-SCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, Carboplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
14 Feb 2024to 27 May 2025
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

  • Has LS-SCLC (stage I-III, by American Joint Committee on Cancer [AJCC] 8th Edition Cancer Staging) and no evidence of extensive stage disease. Participants may enroll at any time between diagnosis and initiation of definitive concurrent chemoradiation or surgery followed by adjuvant chemotherapy. Correlative analyses collected during standard of care definitive concurrent chemoradiation or surgery followed by adjuvant chemotherapy are mandatory
  • Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of small cell lung cancer or high grade neuroendocrine carcinoma will be enrolled in this study
  • Contraception requirements should conform with Clinical Trials Facilitation and Coordination Group (CTFG) guidelines. The pembrolizumab standard for use of highly effective contraceptive methods for persons of child-bearing potential (POCBP) is 120 days (5 half-lives) after the last dose. Please either list the contraception requirement for each compound in the study or use the longest time frame that covers requirements for all compounds in the study
  • Similarly, Company standard for abstaining from breastfeeding after study intervention is at least 5 half-lives. For pembrolizumab, this is 120 days
  • No radiological imaging evidence of disease progression after completion of definitive concurrent chemoradiation or surgery followed by adjuvant chemotherapy
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
Show all 30Show fewer
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention
  • Participants who are hepatitis B surface antibody (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
  • Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
  • Hepatitis B screening tests are not required unless:
  • Known history of HBV infection
  • As mandated by local health authority
  • Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Hepatitis C screening tests are not required unless:
  • Known history of HCV infection
  • As mandated by local health authority Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization
  • Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:
  • Participants on ART must have a CD4+ T-cell count >= 350 cells/mm^3 at the time of screening
  • Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the lower limit of quantitation (LLOQ) (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
  • It is advised that participants must not have had any acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months.
  • Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study
  • The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)
  • Absolute neutrophil count (ANC) >= 1500/uL (specimens must be collected within 10 days prior to the start of study intervention)
  • Platelets >= 100000/uL (specimens must be collected within 10 days prior to the start of study intervention)
  • Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (specimens must be collected within 10 days prior to the start of study intervention)
  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
  • Creatinine or measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine Clearance [CrCl]) =< 1.5 X upper limit of normal (ULN) or >= 30 mL/min for participant with creatinine levels > 1.5 X institutional ULN (specimens must be collected within 10 days prior to the start of study intervention)
  • Creatinine clearance (CrCl) should be calculated per institutional standard
  • Total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 X ULN (specimens must be collected within 10 days prior to the start of study intervention)
  • Alanine aminotransferase (AST) (serum glutamic pyruvic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN (specimens must be collected within 10 days prior to the start of study intervention)
  • International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 10 days prior to the start of study intervention)

Who cannot join

  • 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)
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
  • Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities requiring corticosteroids, and not have had radiation pneumonitis. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study drug
  • Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed
  • 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
  • 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 pembrolizumab
Show all 17Show fewer
  • Has a known additional malignancy that is progressing or requires active treatment. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate adenocarcinoma, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score =< 6, and prostate-specific antigen [PSA]< 10 ng/mL) untreated in active surveillance with stable disease are not excluded
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥ grade 3) to pembrolizumab
  • 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 and is allowed
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
  • Has had an allogenic tissue/solid organ transplant
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: A Single Arm Trial of Adjuvant Pembrolizumab in Patients With Limited Stage Small Cell Lung Cancer

This phase II trial studies how well pembrolizumab after standard treatment with radiation plus the following chemotherapy drugs: cisplatin or carboplatin, plus etoposide works in treating patients with limited stage small cell lung cancer (LS-SCLC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after standard treatment with radiation plus chemotherapy may increase the ability of the immune system to fight LS-SCLC.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To investigate progression free survival per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the investigator in patients with limited stage small cell lung cancer treated with adjuvant pembrolizumab.

SECONDARY OBJECTIVES:

  1. Assess median overall survival compared to the historical control dataset (CONVERT trial1) median overall survival (OS) of 30 months.

II. Assess the safety and tolerability of adjuvant pembrolizumab in patients with limited stage SCLC.

EXPLORATORY/TRANSLATIONAL OBJECTIVES:

  1. To determine whether patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) after curative intent therapy ("minimal residual disease [MRD] positive") experience shorter median progression free survival (PFS) compared to patients without detectable ctDNA after curative intent therapy ("MRD negative.").

II. Determination of whether patients with ctDNA clearance at any point during curative intent therapy have superior median PFS compared to patients who do not experience ctDNA clearance during curative intent therapy.

OUTLINE:

Patients undergo radiation therapy and receive cisplatin or carboplatin on day 1 of each cycle and etoposide on days 1-3 for 4 cycles. Patients then receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET) scan during screening. Patients also undergo magnetic resonance imaging (MRI) throughout the trial as well as computed tomography (CT). Additionally, patients undergo blood sample collection throughout the trial.

After completion of study treatment, patients are followed up at 30 days, and every 12 weeks for 2 years.

Medical subject headings
Lung Neoplasms

What participants receive

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

  • CisplatinDrug

    Receive Cisplatin

  • CarboplatinDrug

    Receive Carboplatin

  • EtoposideDrug

    Receive Etoposide

  • PembrolizumabBiological

    Receive Pembrolizumab by IV

  • Computed TomographyProcedure or surgery

    Undergo Computed Tomography

  • Positron Emission TomographyProcedure or surgery

    Undergo Positron Emission Tomography

  • Magnetic Resonance ImagingProcedure or surgery

    Undergo Magnetic Resonance Imaging

  • Biospecimen CollectionProcedure or surgery

    Undergo blood sample collection

  • Radiation TherapyRadiation

    Undergo Radiation Therapy

Study groups in NCT06140407
Study groupRoleWhat they receive
Treatment (pembrolizumab)ExperimentalPatients undergo radiation therapy and receive cisplatin or carboplatin on day 1 of each cycle and etoposide on days 1-3 for 4 cycles. Patients then receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan during screening. Patients also undergo MRI throughout the trial as well as CT. Additionally, patients undergo blood sample collection throughout the trial.
Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Biological: Pembrolizumab; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Radiation: Radiation Therapy

What is being measured

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

  1. Progression-free survival

    Measured: Time from the date of first treatment to progressive disease or death due to any cause, whichever occurs first, assessed up to 3 years

Secondary outcomes (2)

  1. Overall survival

    Measured: Time from the date of first treatment to the date of death due to any cause, assessed up to 3 years

  2. Incidence of adverse events

    Will be assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment.

    Measured: Up to 3 years

Timeline

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

  1. First posted20 Nov 2023
  2. Study start14 Feb 2024
  3. Primary completion27 May 2025
  4. Study completion27 May 2025

Why it stopped: Low accrual and Merck discontinuing funding and drug supply

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06140407
Sponsor's protocol ID
VICCTHO22114
Other IDs
NCI-2023-09018
Status last verified
Jun 2025
First submitted
1 Nov 2023
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Carboplatin and Etoposide in people with Limited Stage Lung Small Cell Carcinoma and Stage I Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

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 30 inclusion and 17 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: stopped early, as of the sponsor's last update on 5 Jun 2025. 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 States. 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 was stopped early (reason given: Low accrual and Merck discontinuing funding and drug supply). Results are not available in the source record.

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 (time frame: Time from the date of first treatment to progressive disease or death due to any cause, whichever occurs first, assessed up to 3 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 NCT06140407.

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 5 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in