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

NCT05387044 | Unknown Phase 2

• 1 other identifier: 2022-OligoSBRT-IIT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC Stage IV

Keywords

NSCLC; Oligoprogressive; Immune checkpoint inhibitors; SBRT

Outcome Measures

Primary Outcomes (1)

• Progress free survival

  PFS was defined from the date of enrollment to the date of disease progression

  two years

Secondary Outcomes (3)

• Overall survival

  two years

• Grade 3 or higher toxicity

  two years

• Time to new metastasis

  2 years

Study Arms (1)

SBRT

EXPERIMENTAL

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

Radiation: SBRT

Interventions

SBRT RADIATION

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

SBRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaojing Lai

  Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojing Lai

CONTACT

13819480002; laixj@zjcc.org.cn

Min Fang, MD

CONTACT

13738152645; fangmin@zjcc.org.cn

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: Clinical Professor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 24, 2022
• Study Start: May 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)