NCT06140407

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. 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: I. 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: I. 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Cisplatin	Receive Cisplatin
DRUG	Carboplatin	Receive Carboplatin
DRUG	Etoposide	Receive Etoposide
BIOLOGICAL	Pembrolizumab	Receive Pembrolizumab by IV
PROCEDURE	Computed Tomography	Undergo Computed Tomography
PROCEDURE	Positron Emission Tomography	Undergo Positron Emission Tomography
PROCEDURE	Magnetic Resonance Imaging	Undergo Magnetic Resonance Imaging
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
RADIATION	Radiation Therapy	Undergo Radiation Therapy

Timeline

• Start date: 2024-02-14
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2023-11-20
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study