NSCLC Stage IVPhase 2NCT05387044
SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors
A Phase 2 study testing SBRT in people with NSCLC Stage IV, run by Zhejiang Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaojing Lai, 13819480002, laixj@zjcc.org.cn
Min Fang, MD, 13738152645, fangmin@zjcc.org.cn
About this study
Official title: An Open-label, Phase II Single Arm Trial of SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors
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
- Being tested
- SBRT
- Keywords
- NSCLC, Oligoprogressive, Immune checkpoint inhibitors, SBRT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Patients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions.
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | Patients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
PFS was defined from the date of enrollment to the date of disease progression
Measured: two years
Secondary outcomes (3)
Overall survival
OS was defined from the date of enrollment until death by any cause or last follow-up.
Measured: two years
Grade 3 or higher toxicity
Treatment-related grade 3 or higher adverse events according to CTCAE 5.0.
Measured: two years
Time to new metastasis
Time to new metastasis was defined from the date of enrollment to the date of new lesion progression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 May 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojing Lai, Zhejiang Cancer Hospital
- Investigators
- Xiaojing Lai, Principal investigator, Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387044
- Sponsor's protocol ID
- 2022-OligoSBRT-IIT
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase II Single Arm Trial of SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT05387044
- Acronym / sponsor ID
- 2022-OligoSBRT-IIT
- Conditions
- NSCLC Stage IV
- Keywords
- NSCLC, Oligoprogressive, Immune checkpoint inhibitors, SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: SBRTPatients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTPatients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions. | Radiation | SBRT |
Primary outcome
Progress free survival
Time frame: two years
PFS was defined from the date of enrollment to the date of disease progression
3 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojing Lai principal investigator
Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT in people with NSCLC Stage IV, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojing Lai (13819480002, laixj@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.