Extensive-stage Small-cell Lung CancerPhase 2NCT06586697
First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy
A Phase 2 study testing Thoracic Radiotherapy in people with Extensive-stage Small-cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- 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
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 20 Mar 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between18 years and 75 years.
- Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
- Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
- Presence of at least one measurable lesion (according to RECIST v1.1).
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver and kidney function.
- Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
Who cannot join
- Previous T cell co-stimulation or immune checkpoint therapy.
- Previous received chemoradiotherapy for limited-stage SCLC.
- Central nervous system metastasis with clinical symptoms.
- Multiple liver metastases (patients with isolated liver metastases, metastatic lesions < 3cm could be included).
- Patients with spinal cord compression.
- Idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia during screening (patients with active pulmonary tuberculosis couldn't be enrolled).
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- Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent.
- In the 5 years prior to the study, subjects had prior or concurrent malignancies requiring active treatment.
- Subjects with any severe and/or uncontrolled disease (hypertension, heart disease, infection, cirrhosis, active hepatitis, AIDS, third space effusion).
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Severe allergic reactions to any of the monoclonal antibodies are known to occur.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
HenanCH
Zhengzhou, Henan, 450000
yang liu, 13676961186, zlyyliuyang1440@zzu.edu.cn
About this study
Official title: Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy：a Phase II, Single Arm, Prospective Trial
This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.
Read the detailed description
This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD after 4-6 cycle of platinum-based chemotherapy in combination with an PD-1/PD-L1 inhibitors. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Thoracic Radiotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic RadiotherapyRadiation
Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Radiotherapy | Experimental | Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w) Receives: Radiation: Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival rate at 6-month
PFS is defined as the period from the start of receiving the first line chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.
Measured: 12 months after last patient entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Henan 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
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586697
- Sponsor's protocol ID
- ES-SCLC-II-01
- Status last verified
- Oct 2023
- First submitted
- 6 May 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy：a Phase II, Single Arm, Prospective Trial
- ClinicalTrials.gov ID
- NCT06586697
- Acronym / sponsor ID
- ES-SCLC-II-01
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 19 Sep 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.
This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.
Detailed description
This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD after 4-6 cycle of platinum-based chemotherapy in combination with an PD-1/PD-L1 inhibitors. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic Radiotherapy | Experimental | Radiation: Thoracic RadiotherapyThoracic Radiotherapy (45Gy /1.5Gy/bid/3w) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between18 years and 75 years.
- Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
- Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
- Presence of at least one measurable lesion (according to RECIST v1.1).
- ECOG performance status of 0 or 1.
Key exclusion criteria (11 listed)
- Previous T cell co-stimulation or immune checkpoint therapy.
- Previous received chemoradiotherapy for limited-stage SCLC.
- Central nervous system metastasis with clinical symptoms.
- Multiple liver metastases (patients with isolated liver metastases, metastatic lesions < 3cm could be included).
- Patients with spinal cord compression.
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 (45Gy /1.5Gy/bid/3w) | Radiation | Thoracic Radiotherapy |
Primary outcome
progression-free survival rate at 6-month
Time frame: 12 months after last patient entry
PFS is defined as the period from the start of receiving the first line chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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. This study is not recruiting at the moment.
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 Extensive-stage Small-cell Lung Cancer, run by Henan 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 8 inclusion and 11 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 19 Sep 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 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 Yang Liu (13676961186, zlyyliuyang1440@zzu.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 rate at 6-month (time frame: 12 months after last patient entry). 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 19 Sep 2024.