Extensive-stage Small Cell Lung CancerPhase 3NCT06719336
Addition of Thoracic Consolidation Radiotherapy to the Maintenance Immunotherapy for ES-SCLC (STONE-001)
A Phase 3 study testing High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy and atezolizumab or durvalumab in people with Extensive-stage Small Cell Lung Cancer, run by Anhui Shi, MD.
Trial summary
This study is expected to enroll 182 patients with partial response or stable disease after first-line immunochemotherapy for extensive-stage small cell lung cancer and eligible for thoracic consolidation radiotherapy within 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy and atezolizumab or durvalumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2024to 16 Dec 2028
- 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
- Fully informed written consent.
- Age ≥ 18 years.
- Confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).
- ECOG PS 0-1.
- No previous systemic therapy except for induction immunochemotherapy for ES-SCLC.
- Partial response or stable disease after 4-6 cycles of induction immunochemotherapy (PD-L1 inhibitor + cisplatin/carboplatin + etoposide). No more than 28 days between last tumor assessment before randomization and randomization.
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- Eligible for thoracic radiotherapy as assessed by the radiotherapy physician (The dose limits predicted for the organs at risk are as follows: bilateral lung V20 ≤ 25%, V5 ≤ 48%).
- Patients with stable, asymptomatic CNS metastases are allowed.
- Adequate bone marrow, renal function, and hepatic function.
- Male or female patients of childbearing potential volunteered to use effective contraception during the study and within 6 months of the last dose of study drug.
Who cannot join
- Prior thoracic radiotherapy.
- History of interstitial lung disease (including but not limited to idiopathic pulmonary fibrosis), pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Positive testing for hepatitis B virus surface antigen (HBV sAg), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus (HIV).
- Leptomeningeal metastasis.
- Uncontrolled tumor-related pain.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
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- Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those treated with expected curative outcome.
- Active or history of autoimmune disease or immune deficiency.
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina.
- Major surgical procedure other than for diagnosis within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the course of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jun Zhao contact
About this study
Official title: Addition of High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy to the Maintenance Therapy with PD-L1 Inhibitor Versus PD-L1 Inhibitor Alone for Extensive Stage Small Cell Lung Cancer (STONE-001)
This study is expected to enroll 182 patients with partial response or stable disease after first-line immunochemotherapy for extensive-stage small cell lung cancer and eligible for thoracic consolidation radiotherapy within 2 years. Patients were randomized 2:1 to immune single-agent maintenance therapy in combination with hyperfractionated high-dose radiotherapy and immune single-agent maintenance therapy after being assessed by the investigator as otherwise eligible for enrollment. Patients in both arms received maintenance therapy with the PD-L1 inhibitor, atezolizumab or dulvedolizumab, until disease progression, unacceptable toxicity, or loss of clinical benefit. Patients in the combined radiotherapy arm required hyperfractionated high-dose (54 Gy) radiotherapy twice daily for residual disease in the chest. Each patient will be followed for approximately 2 years.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy, atezolizumab or durvalumab
- Keywords
- Extensive-stage small cell lung cancer, Thoracic consolidation radiotherapy, Immune Therapy
- 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.
High-dose Hyperfractionated Simultaneous Integrated Boost RadiotherapyRadiation
Twice-daily thoracic radiotherapy at a dose of 54 Gy in 30 fractions with IMRT and VMAT
atezolizumab or durvalumabDrug
atezolizumab 1200 mg Q3W or durvalumab 1500 mg Q4W
| Study group | Role | What they receive |
|---|---|---|
| Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor | Experimental | Not described Receives: Radiation: High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy; Drug: atezolizumab or durvalumab |
| Maintenance therapy with PD-L1 inhibitor | Active comparator | Not described Receives: Drug: atezolizumab or durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: From randomization to the date of death due to any cause, assessed up to 4 years
Secondary outcomes (5)
Progression-free survival (PFS)
Measured: From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 4 years
Landmark analyses of survival
Measured: 1-year and 2-year landmark analysis of OS and 6-month and 1-year landmark analysis of PFS
Best overall response (BOR)
BOR is the percentage of participants who have a CR or a PR, as determined by investigators according to RECIST v1.1.
Measured: Up to 4 years
Confirmed objective response rate (cORR)
cORR is defined as either a confirmed CR or PR on two consecutive evaluations ≥ 4 weeks apart, as determined by investigators according to RECIST v1.1.
Measured: Up to 4 years
Incidence and severity of adverse events
Measured: From randomization to 30 days after the end of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion16 Dec 2028 (estimated)
- Study completion16 Dec 2028 (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.
- 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
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Shi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anhui Shi, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719336
- Sponsor's protocol ID
- STONE-001
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD related to article disclosure data
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy to the Maintenance Therapy with PD-L1 Inhibitor Versus PD-L1 Inhibitor Alone for Extensive Stage Small Cell Lung Cancer (STONE-001)
- ClinicalTrials.gov ID
- NCT06719336
- Acronym / sponsor ID
- STONE-001
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- Extensive-stage small cell lung cancer, Thoracic consolidation radiotherapy, Immune Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Anhui Shi, MDUniversity, hospital or other
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 16 Dec 2028 (estimated)
- Study completion
- 16 Dec 2028 (estimated)
- First posted
- 5 Dec 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 study is expected to enroll 182 patients with partial response or stable disease after first-line immunochemotherapy for extensive-stage small cell lung cancer and eligible for thoracic consolidation radiotherapy within 2 years. Patients were randomized 2:1 to immune single-agent maintenance therapy in combination with hyperfractionated high-dose radiotherapy and immune single-agent maintenance therapy after being assessed by the investigator as otherwise eligible for enrollment. Patients in both arms received maintenance therapy with the PD-L1 inhibitor, atezolizumab or dulvedolizumab, until disease progression, unacceptable toxicity, or loss of clinical benefit. Patients in the combined radiotherapy arm required hyperfractionated high-dose (54 Gy) radiotherapy twice daily for residual disease in the chest. Each patient will be followed for approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor | Experimental | Radiation: High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy, Drug: atezolizumab or durvalumab |
| Maintenance therapy with PD-L1 inhibitor | Active comparator | Drug: atezolizumab or durvalumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fully informed written consent.
- Age ≥ 18 years.
- Confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).
- ECOG PS 0-1.
- No previous systemic therapy except for induction immunochemotherapy for ES-SCLC.
Key exclusion criteria (10 listed)
- Prior thoracic radiotherapy.
- History of interstitial lung disease (including but not limited to idiopathic pulmonary fibrosis), pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Positive testing for hepatitis B virus surface antigen (HBV sAg), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus (HIV).
- Leptomeningeal metastasis.
- Uncontrolled tumor-related pain.
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 |
|---|---|---|
| High-dose Hyperfractionated Simultaneous Integrated Boost RadiotherapyTwice-daily thoracic radiotherapy at a dose of 54 Gy in 30 fractions with IMRT and VMAT | Radiation | Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor |
| atezolizumab or durvalumabatezolizumab 1200 mg Q3W or durvalumab 1500 mg Q4W | Drug | Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor, Maintenance therapy with PD-L1 inhibitor |
Primary outcome
Overall survival (OS)
Time frame: From randomization to the date of death due to any cause, assessed up to 4 years
5 secondary outcomes
Progression-free survival (PFS)
Time frame: From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 4 years
Landmark analyses of survival
Time frame: 1-year and 2-year landmark analysis of OS and 6-month and 1-year landmark analysis of PFS
Best overall response (BOR)
Time frame: Up to 4 years
Confirmed objective response rate (cORR)
Time frame: Up to 4 years
Incidence and severity of adverse events
Time frame: From randomization to 30 days after the end of study treatment
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 5 Dec 2024.
- Individual participant dataSharing planned: Yes. IPD related to article disclosure data
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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.
Jun Zhao contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy and atezolizumab or durvalumab in people with Extensive-stage Small Cell Lung Cancer, run by Anhui Shi, MD.
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 10 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: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Anhui Shi (+8601088196087, anhuidoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From randomization to the date of death due to any cause, assessed up to 4 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 5 Dec 2024.