SCLC,Extensive StagePhase 2NCT05544149
TRT for ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors
A Phase 2 study testing Thoracic radiotherapy in people with SCLC,Extensive Stage, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC,Extensive Stage
- What is being tested?
- Thoracic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Aug 2025
- 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.
- Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive
- Life expectancy >= 3 months.
- Patients are non-progressed after 4 dosed of immunotherapy plus platinum based chemotherapy, with residual thoracic lesions
- Palliative radiotherapy were allowed except for TRT, the interval > 4 weeks
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- 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;
- Sufficient heart and lung function, EF>55%FEV1>50%
- Ability to understand and willingness to provide the informed consent.
- 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;
- Mixed small cell with non-small cell lung cancer histology;
- History of thoracic radiotherapy;
- Malignant pleural or ascites;
- Patients with leptomeningeal metastasis or uncontrolled brain;
- 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.
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- Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis.
- 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
About this study
Official title: An Open-label, Phase II Single Arm Trial of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors.
- Conditions
- SCLC,Extensive Stage
- Being tested
- Thoracic radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic radiotherapyRadiation
Thoracic radiotherapy for ES-SCLC after first line immunecheckpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| TRT | Experimental | Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy. Receives: Radiation: Thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence free survival
From the date of enrollment to the date of local recurrence
Measured: 2 years
Adverse events
Treatment-related adverse events according to CTCAE 5.0.
Measured: 2 years
Secondary outcomes (2)
Progress free survival
From the date of enrollment to the date of disease progression
Measured: 2 years
Overall survival
from the date of enrollment until death by any cause or last follow-up
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 posted16 Sep 2022
- Study start1 Sep 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC,Extensive StageStudies 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
- 42 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
- NCT05544149
- Sponsor's protocol ID
- 2022-TRT-SCLC-IIT
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 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 16 Sep 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 Thoracic Radiotherapy for?ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT05544149
- Acronym / sponsor ID
- 2022-TRT-SCLC-IIT
- Conditions
- SCLC,Extensive Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 16 Sep 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.
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC 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 |
|---|---|---|
| TRT | Experimental | Radiation: Thoracic radiotherapyPatients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy. |
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 at least 18 years.
- ECOG PS 0-1.
- Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive
- Life expectancy >= 3 months.
- Patients are non-progressed after 4 dosed of immunotherapy plus platinum based chemotherapy, with residual thoracic lesions
Key exclusion criteria (10 listed)
- History of another malignancy or concurrent malignancy;
- Mixed small cell with non-small cell lung cancer histology;
- History of thoracic radiotherapy;
- Malignant pleural or ascites;
- Patients with leptomeningeal metastasis or uncontrolled brain;
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 |
|---|---|---|
| Thoracic radiotherapyThoracic radiotherapy for ES-SCLC after first line immunecheckpoint inhibitors | Radiation | TRT |
Primary outcome
Local recurrence free survival
Time frame: 2 years
From the date of enrollment to the date of local recurrence
Adverse events
Time frame: 2 years
Treatment-related adverse events according to CTCAE 5.0.
2 secondary outcomes
Progress free survival
Time frame: 2 years
Overall 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 16 Sep 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 Thoracic radiotherapy in people with SCLC,Extensive Stage, 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 12 inclusion and 10 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 16 Sep 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?
Local recurrence free survival (time frame: 2 years). The study lists 2 primary outcomes in all. 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 16 Sep 2022.