Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLCPhase 2NCT05520853
SBRT Combined With PD-1 Inhibitor and Thoracic Hyperthermia for Advanced NSCLC
A Phase 2 study testing SBRT combined with PD-1 inhibitors and thoracic hyperthermia in people with Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
The aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1 inhibitor and thoracic hyperthermia in patients with EGFR, ALK, and ROS1 negative stage IV NSCLC patients who progressed after first-line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC
- What is being tested?
- SBRT combined with PD-1 inhibitors and thoracic hyperthermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2020to 31 Dec 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
- 1.Age≥18.
- 2.ECOG PS 0-1.
- 3.Histopathologically confirmed stage IV non-small-cell lung cancer.
- 4.EGFR/ALK/ROS-1 negetive.
- 5.Disease progression after first-line therapy including platinum chemotherapy, but not include PD-1/L1 inhibitors.
- 6.Subjects with brain metastases were eligible, but only if they had no neurologic symptoms or disease stable without systemic glucocorticoid.
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- 7.At least one lesion with a diameter of 1-5cm which could be treated with SBRT at a dose of 32Gy/4Fx, and at least one lesion which could be measured other than SBRT (RECIST1.1); Lymph nodes can be used as independent measurable lesions or receive SBRT. Brain lesions should not be used as separate SBRT lesions or as measurable lesions.
- 8.The subjects did not had radiotherapy before.
- 9.The subjects did not currently need palliative radiotherapy at any part according to the researchers.
- 10.It was necessary for the subjects who underwent surgery to fully recover from the toxicity and complications caused by surgical intervention prior to treatment.
- 11.Subjects should provide appropriate biopsy specimens before and during treatment according to the clinical trial protocol.
- 12.Male or female subjects agree to contraception during the trial (surgical ligation or oral contraceptive/IUD + condom).
- 13.Life expectancy ≥ 3 months.
- 14.The organ function level meet the following standards one week before enrollment:
- ①Bone marrow: hemoglobin ≥80g/L, white blood cell count ≥4.010^9/L or neutrophil count ≥1.510^9/L, platelet count ≥10010^9/L.
- ②Liver: Serum total bilirubin level ≤1.5 upper limit of normal (ULN), when serum total bilirubin level > 1.5 ULN, direct bilirubin level must be ≤ ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN.
- ③ Kidney: serum creatinine level < 1.5 ULN or creatinine clearance rate ≥ 50ml/min, urea nitrogen ≤ 200mg/L; Serum albumin ≥ 30g/L.
- 15. Subjects must be able to understand and voluntarily sign informed consent.
Who cannot join
- 1.Prior treatment with anti-PD-1 /L1 drugs or other investigational immunotherapy agent.
- 2.Subjects had prior radiotherapy.
- 3.Subjects had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc.
- 4.Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia.
- 5.Subjects had risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other risk factors for bowel perforation.
- 6.History of other malignant tumors.
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- 7.Subjects who have current infection, heart failure, heart attack, unstable angina, or unstable arrhythmia in the last 6 months.
- 8.Subjects with physical examination or clinical trial findings, or other uncontrolled conditions that the investigator believes may interfere with the outcome or increase the risk of treatment complications.
- 9.Subjects without platinum-based combination chemotherapy included as first-line treatment.
- 10.The pathology reports showed a mixture of small cell lung cancer components.
- 11.Lactating or pregnant women.
- 12.Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or a history of organ transplantation, allogeneic stem cell transplantation.
- 13.Known hepatitis B virus (HBV), hepatitis C virus (HCV), active pulmonary tuberculosis infections.
- 14.Subjects had cancer vaccines other vaccines within 4 weeks before treatment initiation. (Seasonal influenza vaccines are usually inactivated and are permitted, whereas intranasal preparations are usually live attenuated vaccines and therefore are not permitted)
- 15.Subjects who currently use other immune agents, chemotherapy agents, other investigational drugs or long-term cortisol therapy.
- 16.Subjects with mental illness, substance abuse, and social problems that affected compliance were not included in the study according to doctor's evaluation.
- 17.Allergic or contraindicated to PD-1 inhibitors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310002
Bing Xia, MD, 86-0571-56006382, bxia_hzch@hotmail.com
About this study
Official title: An Open, Single-arm, Multicenter Phase II Trial to Evaluate SBRT Combined With PD-1 Inhibitors and Thoracic Hyperthermia for Advanced Non-Small-Cell Lung Cancer
The aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1 inhibitor and thoracic hyperthermia in patients with EGFR, ALK, and ROS1 negative stage IV NSCLC patients who progressed after first-line treatment. At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. During the period, the overall response rate and toxicities were regularly evaluated.
- Being tested
- SBRT combined with PD-1 inhibitors and thoracic hyperthermia
- Medical subject headings
- Hyperthermia, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT combined with PD-1 inhibitors and thoracic hyperthermiaRadiation
At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression.
| Study group | Role | What they receive |
|---|---|---|
| SBRT combined with PD-1 inhibitors and thoracic hyperthermia | Experimental | At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. Receives: Radiation: SBRT combined with PD-1 inhibitors and thoracic hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The proportion of patients evaluated as complete response or partial response
Measured: 2 years
Secondary outcomes (4)
Incidence of treatment-related toxic effects
The proportion of treatment-related toxicity cases to the total number of evaluable cases assessed according to CTCAE 5.0 criteria
Measured: 2 years
Objective response rate of non-irradiated lesions
The proportion of patients with non-irradiated lesions evaluated as complete response or partial response in the total enrolled patients
Measured: 2 years
Overall response
The time span from the first day of enrollment until death from any cause
Measured: 2 years
Progression free survival
The time span from the first day of enrollment until progression or death from any cause
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 posted30 Aug 2022
- Study start20 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Cancer Hospital
- Responsible party
- Principal investigator, Bing Xia, First People's Hospital of Hangzhou
- Investigators
- Bing Xia, MD, Principal investigator, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520853
- Sponsor's protocol ID
- SBRT-PT
- Status last verified
- Aug 2022
- First submitted
- 27 Aug 2022
- Last updated
- 30 Aug 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 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multicenter Phase II Trial to Evaluate SBRT Combined With PD-1 Inhibitors and Thoracic Hyperthermia for Advanced Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05520853
- Acronym / sponsor ID
- SBRT-PT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Hangzhou Cancer Hospital
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Aug 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 aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1 inhibitor and thoracic hyperthermia in patients with EGFR, ALK, and ROS1 negative stage IV NSCLC patients who progressed after first-line treatment. At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. During the period, the overall response rate and toxicities were regularly evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT combined with PD-1 inhibitors and thoracic hyperthermia | Experimental | Radiation: SBRT combined with PD-1 inhibitors and thoracic hyperthermiaAt least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1.Age≥18.
- 2.ECOG PS 0-1.
- 3.Histopathologically confirmed stage IV non-small-cell lung cancer.
- 4.EGFR/ALK/ROS-1 negetive.
- 5.Disease progression after first-line therapy including platinum chemotherapy, but not include PD-1/L1 inhibitors.
Key exclusion criteria (17 listed)
- 1.Prior treatment with anti-PD-1 /L1 drugs or other investigational immunotherapy agent.
- 2.Subjects had prior radiotherapy.
- 3.Subjects had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc.
- 4.Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia.
- 5.Subjects had risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other risk factors for bowel perforation.
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 |
|---|---|---|
| SBRT combined with PD-1 inhibitors and thoracic hyperthermiaAt least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. | Radiation | SBRT combined with PD-1 inhibitors and thoracic hyperthermia |
Primary outcome
Overall response rate
Time frame: 2 years
The proportion of patients evaluated as complete response or partial response
4 secondary outcomes
Incidence of treatment-related toxic effects
Time frame: 2 years
Objective response rate of non-irradiated lesions
Time frame: 2 years
Overall response
Time frame: 2 years
Progression free survival
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 30 Aug 2022.
- Individual participant dataSharing planned: No
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.
Bing Xia, MD principal investigator
Hangzhou 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 combined with PD-1 inhibitors and thoracic hyperthermia in people with Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC, run by First People's Hospital of Hangzhou 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 18 inclusion and 17 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 30 Aug 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 Bing Xia, MD (86-0571-56006382, bxia_hzch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 2 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 30 Aug 2022.