---
title: SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors
nct_id: NCT05387044
overall_status: UNKNOWN
phase: PHASE2
sponsor: Zhejiang Cancer Hospital
study_type: INTERVENTIONAL
primary_condition: NSCLC Stage IV
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05387044.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05387044"
ct_last_update_post_date: 2022-05-24
last_seen_at: "2026-05-12T06:35:01.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors

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

**NCT ID:** [NCT05387044](https://clinicaltrials.gov/study/NCT05387044)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Zhejiang Cancer Hospital
- **Conditions:** NSCLC Stage IV
- **Start Date:** 2022-05-01
- **Completion Date:** 2024-04-30
- **CT.gov Last Update:** 2022-05-24

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **SBRT** (EXPERIMENTAL) — Patients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions.

## Interventions

- **SBRT** (RADIATION) — Patients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions.

## Primary Outcomes

- **Progress free survival** _(time frame: two years)_ — PFS was defined from the date of enrollment to the date of disease progression

## Secondary Outcomes

- **Overall survival** _(time frame: two years)_
- **Grade 3 or higher toxicity** _(time frame: two years)_
- **Time to new metastasis** _(time frame: 2 years)_

## Locations (1)

- Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.zhejiang cancer hospital|hangzhou|zhejiang|china` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05387044.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05387044*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*