An Open-label, Multicenter, Phase II Single Arm Trial of Stereotactic Body Radiotherapy for Oligo-residual Disease After Effective Treatment With PD-1/PD-L1 Inhibitors Among Metastatic Non-small Cell Lung Cancer

Who is this study for? Patients with oligoprogressive NSCLC after treatment with PD-1 inhibitors
What treatments are being studied? PD-1 Blockade+SBRT
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;

⁃ Adequate hepatic function: total bilirubin \< 1.5 x upper limit of normal (ULN). Note: If total bilirubin is \> 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;

⁃ Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;

• Ability to understand and willingness to provide the informed consent.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Zhengfei Zhu, MD
fuscczzf@163.com
+86-18017312901
Backup
Jianjiao Ni, MD
nijianjiao8@sina.com
13761974092
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 59
Treatments
Experimental: SBRT for oligo-residual NSCLC
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov