SBRT for Oligo-residual NSCLC After Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors

NCT04767009 | Recruiting Phase 2

• 1 other identifier: 2020-NSCLCSBRT-2
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the impressive response rate to PD-1/PD-L1 immune checkpoint inhibitors, resistance inevitably develops in most patients. 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 oligo-residual NSCLC after effective treatment with PD-1/PD-L1 inhibitors.

Conditions

NSCLC Stage IV

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  PFS was measured from the date of the initiation of treatment with PD-1/PD-L1 inhibitors to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death.

  Two years

Secondary Outcomes (2)

• Percentage of Participants With Adverse Events

  Two year

• Overall Survival

  Two years

Study Arms (1)

SBRT for oligo-residual NSCLC

EXPERIMENTAL

Drug: PD-1/PD-L1 inhibitors (alone or in combination with chemotherapy); Radiation: SBRT

Interventions

PD-1/PD-L1 inhibitors (alone or in combination with chemotherapy) DRUG

Patients will receive PD-1/PD-L1 inhibitors for up to 2 years or until confirmed progression or unacceptable toxicity. PD-1/PD-L1 inhibitors will be administrated as an intravenous(IV) infusion.

SBRT for oligo-residual NSCLC

SBRT RADIATION

Patients with oligo-residual NSCLC after effective treatment with PD-1/PD-L1 inhibitors will be treated with curative-intent SBRT of residual lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. PD-1/PD-L1 inhibitors will be withheld one day before the treatment and resumed within 2 weeks after completion of SBRT.

Also known as: Stereotactic body radiation therapy

SBRT for oligo-residual NSCLC

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.
• Negative for driver genes including EGFR, ALK, and ROS-1.
• Oligo-residual disease after effective treatment with PD-1/PD-L1 inhibitors that would be amenable to SBRT in the opinion of the investigator.
• Patients with brain metastasis are eligible if they are asymptomatic, neurologically stable, and off corticosteroids.
• Patients with a history of radiotherapy are eligible if they satisfy the following criteria:
• Radiotherapy administered more than 4 weeks before study entry.
• At least one measurable lesion outside the radiation field.
• Patients with no indications for palliative radiotherapy in the opinion of the investigator.
• Patients with a prior history of surgery are eligible if they have sufficiently recovered from the toxicity and/or complications of surgery.
• 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.
• Life expectancy of more than 3 months.
• Adequate organ function within 1 week prior to enrollment:

You may not qualify if:

• 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.
• Any evidence of severe or uncontrolled systemic diseases, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.
• Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
• Mixed small cell with non-small cell lung cancer histology.
• The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
• Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment. Note: Influenza vaccination is permitted only during influenza season, while live, attenuated influenza vaccine such as FluMist is not allowed.
• Patients receiving immunosuppressive agents, or other investigational treatment. Long-term corticosteroid users are also excluded.
• Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.
• Prior allergic reaction or contraindications to PD-1/PD-L1 inhibitors.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Single Person; Drug Therapy; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Therapeutics; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Zhengfei Zhu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengfei Zhu, MD

CONTACT

+86-18017312901; fuscczzf@163.com

Jianjiao Ni, MD

CONTACT

13761974092; nijianjiao8@sina.com

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: Professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2024-04

Locations

CN (1)