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

NCT06140407 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: VICCTHO22114NCI-2023-09018
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Limited Stage Lung Small Cell Carcinoma; Stage I Lung Cancer; Stage II Lung Cancer; Stage III Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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)

• Overall survival

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

• Incidence of adverse events

  Up to 3 years

Study Arms (1)

Treatment (pembrolizumab)

EXPERIMENTAL

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 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.

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

Interventions

Cisplatin DRUG

Receive Cisplatin

Treatment (pembrolizumab)

Carboplatin DRUG

Receive Carboplatin

Treatment (pembrolizumab)

Etoposide DRUG

Receive Etoposide

Treatment (pembrolizumab)

Pembrolizumab BIOLOGICAL

Receive Pembrolizumab by IV

Treatment (pembrolizumab)

Computed Tomography PROCEDURE

Undergo Computed Tomography

Treatment (pembrolizumab)

Positron Emission Tomography PROCEDURE

Undergo Positron Emission Tomography

Treatment (pembrolizumab)

Magnetic Resonance Imaging PROCEDURE

Undergo Magnetic Resonance Imaging

Treatment (pembrolizumab)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Treatment (pembrolizumab)

Radiation Therapy RADIATION

Undergo Radiation Therapy

Treatment (pembrolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Carboplatin; Etoposide; pembrolizumab; Magnetic Resonance Spectroscopy; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Therapeutics

Study Officials

• Ryan Whitaker, MD, PhD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 20, 2023
• Study Start: February 14, 2024
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)