Metastatic Non-Small Cell Lung CancerPhase 3OPPRESSNCT06523673
Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer
A Phase 3 study testing Stereotactic Body Radiotherapy and second-line systemic therapy in people with Metastatic Non-Small Cell Lung Cancer and NSCLC Stage IV, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer, NSCLC Stage IV, OligoProgressive Metastatic Disease
- What is being tested?
- Stereotactic Body Radiotherapy and second-line systemic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 ≥ 18 years. Gender is not limited.
- Histologically and/or cytologically confirmed stage IV metastatic NSCLC.
- Eastern Cooperative Oncology Group (ECOG) score of 0-2.
- Patients who had prior first-line chemotherapy with clinical benefit lasting for ≥3 months.
- Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Driver gene-positive NSCLC patients, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, are allowed to enroll if oligo-progression occurred during treatment with first-line chemotherapy combined with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy.
- Progressive sites were assessed as ≤5 according to RECIST v1.1 criteria combined with positron emission tomography / computertomography (PET/CT), and all were located extracranially. Progressive lymph node lesions are counted by region, with each lymph node region amenable to concurrent SBRT (which may contain multiple progressive lymph nodes) counted as 1 progressive site.
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- All progressive sites should be visible on radiologic imaging and assessed as suitable for SBRT treatment by a radiotherapist.
- Intracranial progressive lesions and symptomatic lesions can be treated with palliative radiotherapy and local therapy prior to enrollment and are not counted within the oligo-progressive sites.
- Expected survival time greater than 3 months.
- Comprehensive examination completed within 28 days prior to enrollment in the study and a complete blood count/differential, collected within 15 days, showing that the patient has normal internal organ function and normal bone marrow function.
- Negative serum or urine pregnancy test in females of childbearing age within 14 days prior to study enrollment.
- Patients are willing to provide written informed consent and must be willing to adhere to the prescribed follow-up schedule.
Who cannot join
- Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.
- Pregnant or lactating women.
- Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.
- Presence of untreated intracranial metastases or symptomatic progressive sites.
- History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years.
- Serious active comorbidities that would interfere with treatment in this study.
- History or evidence of disease that could interfere with the results of the trial, prevent the subject from participating in the study throughout, abnormal values of treatment or laboratory tests, or other conditions that, in the opinion of the investigator, make enrollment inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Fuming Qiu, PhD, 13858005908, qiufuming@zju.edu.cn
About this study
Official title: Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study
The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:
Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?
Read more
Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.
Participants will:
Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.
Read the detailed description
This study is a prospective, randomized, controlled, open-label, multi-center phase Ⅲ study of patients with stage IV NSCLC who developed oligo-progression after prior first-line chemotherapy with clinical benefit lasting for ≥3 months, aiming to evaluate the efficacy and safety of applying SBRT to treat oligo-progressive NSCLC.
NSCLC patients with oligo-progression (≤5 extracranial progression sites) after ≥3 months of clinical benefit by first-line systemic therapy and who are suitable for SBRT will be screened to meet the enrollment criteria after signing the informed consent and will be randomized to the SBRT/standard of care (SOC) groups according to the stratification ratio of 1:1.
SBRT group: SBRT was performed on the progressive sites. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. Evaluation was performed after completion of SBRT treatment. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC).
SOC group: Second-line systemic therapy is based on docetaxel or albumin-paclitaxel. The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician. The specific drug regimen is determined in conjunction with the patient's wishes. Palliative radiotherapy is acceptable.
- Conditions
- Metastatic Non-Small Cell Lung Cancer, NSCLC Stage IV, OligoProgressive Metastatic Disease
- Being tested
- Stereotactic Body Radiotherapy, second-line systemic therapy
- 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.
Stereotactic Body RadiotherapyRadiation
Also called SBRT, Stereotactic Ablative Radiotherapy (SABR)
The dose of radiation therapy is determined by the radiologist based on the clinical parameters of the lesion, including tumor size and location. In most cases, radiotherapy fractionation regimens range from 27-30 Gy/3 Fractions or 30-50 Gy/5 Fractions, and appropriate radiotherapy doses covering 27-70 Gy/3-10 Fractions can also be selected by the radiologist based on radiation limitations of neighboring endangered organs.
second-line systemic therapyDrug
Also called docetaxel-based chemotherapy, albumin-bound paclitaxel-based chemotherapy, immunotherapy
a second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen
| Study group | Role | What they receive |
|---|---|---|
| SBRT arm | Experimental | SBRT is administered to the site of progression. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC). Receives: Radiation: Stereotactic Body Radiotherapy; Drug: second-line systemic therapy |
| SOC arm | Active comparator | Second-line systemic therapy is based on docetaxel or albumin-paclitaxel. The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician. The specific drug regimen is determined in conjunction with the patient's wishes. Palliative radiotherapy is acceptable. Receives: Drug: second-line systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Progression-free survival, PFS: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first.
Measured: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first, assessed up to 18 months.
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival，OS: Time from date of randomization to death (from any cause).
Measured: Time from date of randomization to death (from any cause), assessed up to 36 months.
Quality of Life (QoL)
Patient quality of life will be assessed using the patient-reported European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - Core 30 (EORTC QLQ-C-30) scale. Patient-reported EORTC-QLQ-C30 scale results will be scaled and scored according to the procedures recommended by the EORTC Quality of Life Panel, and scale scores for each visit period of the trial will be analyzed, as well as change values relative to baseline.
Measured: From enrollment to the end of survival follow-up at 36 months.
Safety of SBRT
the safety of SBRT
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuming Qiu, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523673
- Sponsor's protocol ID
- OPPRESS
- Acronym
- OPPRESS
- Status last verified
- Aug 2024
- First submitted
- 28 Jun 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study
- ClinicalTrials.gov ID
- NCT06523673
- Acronym / sponsor ID
- OPPRESS / OPPRESS
- Conditions
- Metastatic Non-Small Cell Lung Cancer, NSCLC Stage IV, OligoProgressive Metastatic Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Jul 2024 (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 goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:
Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?
Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.
Participants will:
Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.
Detailed description
This study is a prospective, randomized, controlled, open-label, multi-center phase Ⅲ study of patients with stage IV NSCLC who developed oligo-progression after prior first-line chemotherapy with clinical benefit lasting for ≥3 months, aiming to evaluate the efficacy and safety of applying SBRT to treat oligo-progressive NSCLC.
NSCLC patients with oligo-progression (≤5 extracranial progression sites) after ≥3 months of clinical benefit by first-line systemic therapy and who are suitable for SBRT will be screened to meet the enrollment criteria after signing the informed consent and will be randomized to the SBRT/standard of care (SOC) groups according to the stratification ratio of 1:1.
SBRT group: SBRT was performed on the progressive sites. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. Evaluation was performed after completion of SBRT treatment. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC).
SOC group: Second-line systemic therapy is based on docetaxel or albumin-paclitaxel. The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician. The specific drug regimen is determined in conjunction with the patient's wishes. Palliative radiotherapy is acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT arm | Experimental | Radiation: Stereotactic Body Radiotherapy, Drug: second-line systemic therapySBRT is administered to the site of progression. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC). |
| SOC arm | Active comparator | Drug: second-line systemic therapySecond-line systemic therapy is based on docetaxel or albumin-paclitaxel. The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician. The specific drug regimen is determined in conjunction with the patient's wishes. Palliative radiotherapy is acceptable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years. Gender is not limited.
- Histologically and/or cytologically confirmed stage IV metastatic NSCLC.
- Eastern Cooperative Oncology Group (ECOG) score of 0-2.
- Patients who had prior first-line chemotherapy with clinical benefit lasting for ≥3 months.
- Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Driver gene-positive NSCLC patients, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, are allowed to enroll if oligo-progression occurred during treatment with first-line chemotherapy combined with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy.
Key exclusion criteria (7 listed)
- Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.
- Pregnant or lactating women.
- Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.
- Presence of untreated intracranial metastases or symptomatic progressive sites.
- History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years.
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 |
|---|---|---|
| Stereotactic Body RadiotherapyAlso: SBRT, Stereotactic Ablative Radiotherapy (SABR)The dose of radiation therapy is determined by the radiologist based on the clinical parameters of the lesion, including tumor size and location. In most cases, radiotherapy fractionation regimens range from 27-30 Gy/3 Fractions or 30-50 Gy/5 Fractions, and appropriate radiotherapy doses covering 27-70 Gy/3-10 Fractions can also be selected by the radiologist based on radiation limitations of neighboring endangered organs. | Radiation | SBRT arm |
| second-line systemic therapyAlso: docetaxel-based chemotherapy, albumin-bound paclitaxel-based chemotherapy, immunotherapya second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen | Drug | SBRT arm, SOC arm |
Primary outcome
progression-free survival (PFS)
Time frame: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first, assessed up to 18 months.
Progression-free survival, PFS: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first.
3 secondary outcomes
Overall Survival (OS)
Time frame: Time from date of randomization to death (from any cause), assessed up to 36 months.
Quality of Life (QoL)
Time frame: From enrollment to the end of survival follow-up at 36 months.
Safety of SBRT
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- 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.
Fuming Qiu, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic Body Radiotherapy and second-line systemic therapy in people with Metastatic Non-Small Cell Lung Cancer and NSCLC Stage IV, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 12 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Aug 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuming Qiu, PhD (86+13858005908, qiufuming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first, assessed up to 18 months.). 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 30 Aug 2024.