Extensive-stage Small Cell Lung CancerPhase 1/2NCT06479473
Radiotherapy to All Residual Lesions After Chemoimmunotherapy
A Phase 1/2 study testing Radiotherapy to all residual lesions and Chemoimmunotherapy in people with Extensive-stage Small Cell Lung Cancer, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis. First-line chemotherapy could only achieve an overall survival of approximately 10 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Radiotherapy to all residual lesions and Chemoimmunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Mar 2026
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old;
- ECOG 0-1;
- Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;
- Small-cell lung cancer;
- Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
- Signature of inform consent.
Who cannot join
- Younger than 18 years old or older than 70 years old;
- ECOG\>1;
- Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;
- Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
- Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
- No signature of inform consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230011
Dong Qian, M.D., 800-666-7777, bingyan29618@ustc.edu.cn
Dong Qian, M.D
About this study
Official title: Chemoimmunotherapy Followed by All-residual-lesions Radiotherapy for Extensive-stage Small-cell Lung Cancer: A Phase I/II Trial
Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis. First-line chemotherapy could only achieve an overall survival of approximately 10 months. CREST study demonstrated that the addition of thoracic radiotherapy to the patients who responded to chemotherapy could increase the 2-year survival rate from 3% to 13%. CASPIAN and IMpower 133 trials have established the standard modality of first-line chemoimmunotherapy for extensive-stage small-cell lung cancer and prolonged the overall survival to 13 months. Both the addition of thoracic radiotherapy and immunotherapy to chemotherapy were able to improve the survival. Recently, several retrospective studies have demonstrated the effectiveness and safety of the combination of thoracic radiotherapy and chemoimmunotherapy. In a prospective study, 4-6 cycles of first-line chemotherapy with Adebrelimab followed by thoracic radiotherapy achieved the progression-free survival of 10.1 months and overall survival of 21.4 months, which was longer than chemoimmunotherapy. Another study demonstrated not only thoracic radiotherapy, but also radiotherapy to metastatic lesions could ameliorate survival. Therefore, we supposed that whether radiotherapy to all residual lesions after first-line chemoimmunotherapy could further improve survival for patients with extensive-stage small-cell lung cancer.
Read the detailed description
Trial design: To enroll 150 patients diagnosed with extensive-stage small-cell lung cancer to receive first-line chemoimmunotherapy with or without radiotherapy to all residual lesions.
Primary endpoint: Progression-free Survival Secondary endpoint: Overall Survival, Objective Response Rate, Duration of Response, Disease Control Rate.
Randomization: All the enrolled patients would be randomly assigned to chemoimmunotherapy group and chemoimmunotherapy with radiotherapy group using random table method.
All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy (etoposide and cisplatin \& carboplatin with Adebrelimab). Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years.
Chemoimmunotherapy: Etoposide 80-100mg/m2 day 1, 2, 3 and cisplatin 75-80mg/m2 day 1 \& carboplatin AUC 5 day 1 and Adebrelimab 1200mg day 1 q3w totally 4 to 6 cycles.
Immunotherapy maintenance: Adebrelimab 1200mg q3w to 2 year or disease progression \& untolerated toxicity.
Response evaluation: After 4 to 6 cycles of chemoimmunotherapy, patients would undertake response evaluation according to RECIST criteria. These patients who were evaluated as partial response and stable disease could be included into the study and receive randomization.
Radiotherapy to residual lesions: Patients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions. All residual lesions would be irradiated in a hypofractionated manner. Radiotherapy should be completed in two weeks. The suggested dose fraction for different lesion was as follows:
Thoracic lesion: 40Gy/10f Cranial lesion: Hippocamps-sparing whole brain irradiation of 30Gy/10f with or without simultaneous integrated lesion boost of 40Gy/10f Hepatic or adrenal lesion: 40Gy/10f Osseous lesion: 30Gy/10f or 40Gy/10f Dose constraint to organs at risk could be referred to QUANTEC criteria (30Gy/10f) and Timmerman's sheet (40Gy/10f) Follow-up: Patients should be follow-up every three months right after the completion of the final cycle of immunotherapy to 3 years after that. Then follow-up every half year is allowed to 5 years. After 5 years, follow-up every year is appropriate. In follow-up, chest CT and abdominal ultrasonography should be implemented. Cranial MRI should be performed every half year. Bone scan should be undertaken every year for all patients.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Radiotherapy to all residual lesions, Chemoimmunotherapy
- Keywords
- small-cell lung cancer, extensive-stage, radiotherapy, residual lesion
- 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.
Radiotherapy to all residual lesionsRadiation
Patients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions. All residual lesions would be irradiated in a hypofractionated manner.
ChemoimmunotherapyDrug
atients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of chemoimmunotherapy followed by consolidative immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chemoimmunotherapy group | Active comparator | Patients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by immunotherapy maintenance to 2 years. Receives: Drug: Chemoimmunotherapy |
| Chemoimmunotherapy with radiotherapy group | Experimental | Patients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by radiotherapy to all residual lesions and immunotherapy maintenance to 2 years. Receives: Radiation: Radiotherapy to all residual lesions; Drug: Chemoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
The survival time from diagnose of the disease to progression of the disease
Measured: 3 years
Secondary outcomes (1)
Overall Survival
The survival time from diagnose of the disease to death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 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 Anhui Provincial 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy (etoposide and cisplatin \& carboplatin with Adebrelimab). Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dong Qian, Anhui Provincial Hospital
- Investigators
- Dong Qian, M.D, Principal investigator, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479473
- Sponsor's protocol ID
- 2024-ky236
- Status last verified
- Aug 2024
- First submitted
- 24 Jun 2024
- Last updated
- 9 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoimmunotherapy Followed by All-residual-lesions Radiotherapy for Extensive-stage Small-cell Lung Cancer: A Phase I/II Trial
- ClinicalTrials.gov ID
- NCT06479473
- Acronym / sponsor ID
- 2024-ky236
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- small-cell lung cancer, extensive-stage, radiotherapy, residual lesion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Jun 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.
Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis. First-line chemotherapy could only achieve an overall survival of approximately 10 months. CREST study demonstrated that the addition of thoracic radiotherapy to the patients who responded to chemotherapy could increase the 2-year survival rate from 3% to 13%. CASPIAN and IMpower 133 trials have established the standard modality of first-line chemoimmunotherapy for extensive-stage small-cell lung cancer and prolonged the overall survival to 13 months. Both the addition of thoracic radiotherapy and immunotherapy to chemotherapy were able to improve the survival. Recently, several retrospective studies have demonstrated the effectiveness and safety of the combination of thoracic radiotherapy and chemoimmunotherapy. In a prospective study, 4-6 cycles of first-line chemotherapy with Adebrelimab followed by thoracic radiotherapy achieved the progression-free survival of 10.1 months and overall survival of 21.4 months, which was longer than chemoimmunotherapy. Another study demonstrated not only thoracic radiotherapy, but also radiotherapy to metastatic lesions could ameliorate survival. Therefore, we supposed that whether radiotherapy to all residual lesions after first-line chemoimmunotherapy could further improve survival for patients with extensive-stage small-cell lung cancer.
Detailed description
Trial design: To enroll 150 patients diagnosed with extensive-stage small-cell lung cancer to receive first-line chemoimmunotherapy with or without radiotherapy to all residual lesions.
Primary endpoint: Progression-free Survival Secondary endpoint: Overall Survival, Objective Response Rate, Duration of Response, Disease Control Rate.
Randomization: All the enrolled patients would be randomly assigned to chemoimmunotherapy group and chemoimmunotherapy with radiotherapy group using random table method.
All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy (etoposide and cisplatin \& carboplatin with Adebrelimab). Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years.
Chemoimmunotherapy: Etoposide 80-100mg/m2 day 1, 2, 3 and cisplatin 75-80mg/m2 day 1 \& carboplatin AUC 5 day 1 and Adebrelimab 1200mg day 1 q3w totally 4 to 6 cycles.
Immunotherapy maintenance: Adebrelimab 1200mg q3w to 2 year or disease progression \& untolerated toxicity.
Response evaluation: After 4 to 6 cycles of chemoimmunotherapy, patients would undertake response evaluation according to RECIST criteria. These patients who were evaluated as partial response and stable disease could be included into the study and receive randomization.
Radiotherapy to residual lesions: Patients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions. All residual lesions would be irradiated in a hypofractionated manner. Radiotherapy should be completed in two weeks. The suggested dose fraction for different lesion was as follows:
Thoracic lesion: 40Gy/10f Cranial lesion: Hippocamps-sparing whole brain irradiation of 30Gy/10f with or without simultaneous integrated lesion boost of 40Gy/10f Hepatic or adrenal lesion: 40Gy/10f Osseous lesion: 30Gy/10f or 40Gy/10f Dose constraint to organs at risk could be referred to QUANTEC criteria (30Gy/10f) and Timmerman's sheet (40Gy/10f) Follow-up: Patients should be follow-up every three months right after the completion of the final cycle of immunotherapy to 3 years after that. Then follow-up every half year is allowed to 5 years. After 5 years, follow-up every year is appropriate. In follow-up, chest CT and abdominal ultrasonography should be implemented. Cranial MRI should be performed every half year. Bone scan should be undertaken every year for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy (etoposide and cisplatin \& carboplatin with Adebrelimab). Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years.
| Arm | Type | Receives |
|---|---|---|
| Chemoimmunotherapy group | Active comparator | Drug: ChemoimmunotherapyPatients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by immunotherapy maintenance to 2 years. |
| Chemoimmunotherapy with radiotherapy group | Experimental | Radiation: Radiotherapy to all residual lesions, Drug: ChemoimmunotherapyPatients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by radiotherapy to all residual lesions and immunotherapy maintenance to 2 years. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-70 years old;
- ECOG 0-1;
- Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;
- Small-cell lung cancer;
- Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
Key exclusion criteria (6 listed)
- Younger than 18 years old or older than 70 years old;
- ECOG\>1;
- Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;
- Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
- Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
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 |
|---|---|---|
| Radiotherapy to all residual lesionsPatients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions. All residual lesions would be irradiated in a hypofractionated manner. | Radiation | Chemoimmunotherapy with radiotherapy group |
| Chemoimmunotherapyatients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of chemoimmunotherapy followed by consolidative immunotherapy | Drug | Chemoimmunotherapy group, Chemoimmunotherapy with radiotherapy group |
Primary outcome
Progression-free Survival
Time frame: 3 years
The survival time from diagnose of the disease to progression of the disease
1 secondary outcome
Overall Survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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. This study is not recruiting at the moment.
Dong Qian, M.D principal investigator
Anhui Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiotherapy to all residual lesions and Chemoimmunotherapy in people with Extensive-stage Small Cell Lung Cancer, run by Anhui Provincial 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 6 inclusion and 6 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 9 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Dong Qian, M.D. (+8619156007756, qiandong@ustc.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 (time frame: 3 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 9 Aug 2024.