Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer

NCT06514118 | Recruiting

• 1 other identifier: KY202400902
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably happens. Residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.

Conditions

Small-cell Lung Cancer; Residual Tumor; Radiation

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  PFS: time to disease progression or patient death

  24 months

Secondary Outcomes (1)

• Overall survival (OS)

  36 months

Study Arms (1)

Combined chemotherapy and immunotherapy plus residual lesion irradiation

Patients receive carboplatin 5/AUC intravenously (IV) on day 1, adebrelimab 1200mg IV on day 1, and etoposide100mg/m2 IV on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity; redsidual tumor irradiation for 50GY in 25 fraction.

Radiation: residual tumor irradiation

Interventions

residual tumor irradiation RADIATION

lung residual tumor will be given external beam irradiation for 50GY in 25 fractions in total

Combined chemotherapy and immunotherapy plus residual lesion irradiation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with extensive disease of small-cell lung cancer are enrolled and treated with chemotherapy plus PD-L1 immunotherapy for 4 cycles. Patients with esponse or stable disease are selected to receive residual lesions irratiation for 50GY/25f.

You may qualify if:

• \>= 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 at the time of study treatment initiation Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in the contralateral lung, and/or the presence of extra-thoracic metastatic disease Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic chemotherapy Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L Platelets \>= 100 x 10\^9/L Hemoglobin \>= 9 g/dL Serum creatinine =\< 1.5 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml/min.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (ALT and AST =\< 5 x ULN is acceptable if liver metastases are present) Total serum bilirubin =\< 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =\< 3 x ULN with direct bilirubin within normal range.
• Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure.

You may not qualify if:

• ad major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment Patient has known hypersensitivity to the components of the study drugs or any analogs History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, including, but not limited to: Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease. History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline. Poorly controlled arrhythmias

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (3)

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• chunling zhang, md

  Qingdao Central Hospital

  STUDY CHAIR

Central Study Contacts

chunling zhang, md

CONTACT

1718865657; kevinji78@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 23, 2024
• Study Start: April 17, 2024
• Primary Completion: March 16, 2026
• Study Completion (Estimated): March 16, 2027
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CN (3)