SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors

NSCLC Stage IV Clinical Trial

Official title:

An Open-label, Phase II Single Arm Trial of SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387044
• Other study ID #: 2022-OligoSBRT-IIT
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2022
• Source: Zhejiang Cancer Hospital
• Contact: Xiaojing Lai
• Phone: 13819480002
• Email: laixj[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The treatment modality with immunotherapy has been the first-line standard treatment for advanced NSCLC. But more than 2/3 patients still develop acquired drug resistance within 5 years of immunotherapy, and more than 1/2 patients are oligoprogressive. Stereotactic body radiation therapy (SBRT) plays a growing role in the management of oligometastatic disease. This study aims to evaluate the efficacy and safety of SBRT for oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age at least 18 years;

• ECOG PS 0-1;

• Patients with pathologically confirmed stage IV NSCLC by tumor biopsy and/or fine-needle aspiration (AJCC the 8th Edition);

• Stable Disease for at least 6 months after first line immunotherapy;

• Oligoprogressive disease in 5 or fewer lesions and 3 or fewer organs;

• All oligopreogressive lesion = 5cm, and intracranial lesion =3cm or 30cc;

• Progressive disease would be amenable to SBRT and without indications for palliative radiotherapy in the opinion of the investigator;

• Patients with a history of radiotherapy are eligible if radiotherapy administered more than 4 weeks before study entry;

• Adequate organ function prior to enrollment:

Adequate bone marrow function: white blood cell (WBC) count = 3.0 * 10 ^ 9/L or neutrophil count = 1.5 * 10 ^ 9/L, platelet count = 100 * 10 ^ 9/L and hemoglobin =90g/L,; Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine= 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =2.0 ULN;

• Life expectancy of more than 3 months;

• Ability to understand and willingness to provide the informed consent and signed informed consent for the use of fresh tumor biopsies before and during the treatment;

• Women of childbearing age and men must agree to use effective contraception during the trial.

Exclusion Criteria:

• History of another malignancy or concurrent malignancy (except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or I breast cancer, non-invasive bladder cancer, cervical cancer in situ);

• Positive for driver genes including EGFR, ALK, and ROS-1;

• Mixed small cell with non-small cell lung cancer histology;

• Malignant pleural or ascites;

• Patients with brain metastasis require intracranial decompression;

• Symptoms of spinal cord compression;

• Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitides;

• Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis.

• History of another malignancy or concurrent malignancy;

• Active infection, congestive heart failure, or any evidence of myocardial infarction, unstable angina pectoris or cardiac arrhythmia within 6 months prior to enrollment;

• The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding;

• Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC Stage IV

Intervention

Radiation:
• SBRT
Patients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival	PFS was defined from the date of enrollment to the date of disease progression	two years
Secondary	Overall survival	OS was defined from the date of enrollment until death by any cause or last follow-up.	two years
Secondary	Grade 3 or higher toxicity	Treatment-related grade 3 or higher adverse events according to CTCAE 5.0.	two years
Secondary	Time to new metastasis	Time to new metastasis was defined from the date of enrollment to the date of new lesion progression.	2 years