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Trial Title:
Radiotherapy to All Residual Lesions After Chemoimmunotherapy
NCT ID:
NCT06479473
Condition:
Extensive-stage Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Conditions: Keywords:
small-cell lung cancer
extensive-stage
radiotherapy
residual lesion
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy to all residual lesions
Description:
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.
Arm group label:
Chemoimmunotherapy with radiotherapy group
Intervention type:
Drug
Intervention name:
Chemoimmunotherapy
Description:
atients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of
chemoimmunotherapy followed by consolidative immunotherapy
Arm group label:
Chemoimmunotherapy group
Arm group label:
Chemoimmunotherapy with radiotherapy group
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230011
Country:
China
Status:
Recruiting
Contact:
Last name:
Dong Qian, M.D.
Phone:
800-666-7777
Email:
bingyan29618@ustc.edu.cn
Investigator:
Last name:
Dong Qian, M.D
Email:
Principal Investigator
Start date:
June 1, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06479473
