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Trial Title:
Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment in Extensive Stage Small Cell Lung Cancer With Oligometastases
NCT ID:
NCT05484583
Condition:
Lung Cancer
Extensive-stage Small-cell Lung Cancer
Radiotherapy
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Durvalumab
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Durvalumab + carboplatin/cisplatin + etoposide
Description:
Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab +
carboplatin/cisplatin + etoposide, intravenous drip
Arm group label:
Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin
Intervention type:
Radiation
Intervention name:
Consolidation radiotherapy
Description:
Consolidation radiotherapy period: radiotherapy for primary chest lesions +
oligometastatic lesions.
Arm group label:
Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion
Arm group label:
Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin
Summary:
In patients with oligometastatic (1-5 lesions) extensive-stage small cell lung cancer, to
explore the efficacy and safety of Durvalumab immunotherapy combined with chemotherapy
followed by consolidation radiotherapy, to provide scientific basis for the formulation
of the best comprehensive treatment plan in the future.
Detailed description:
To explore the efficacy and safety of consolidation radiotherapy after Durvalumab
immunotherapy combined with chemotherapy in patients with oligometastatic small cell lung
cancer (1-5 lesions), so as to provide scientific basis for making the best comprehensive
treatment plan in the future.All subjects will receive the following treatments:
1. Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab +
carboplatin/cisplatin + etoposide, intravenous drip
2. Consolidation radiotherapy period: radiotherapy for primary chest lesions +
oligometastatic lesions.
3. Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion.
Criteria for eligibility:
Criteria:
1. Histology or cytology confirmed small cell lung cancer
2. The number of metastatic lesions is less than 5 (oligometastatic)
3. According to the seventh edition of the American Joint Cancer Board, IV or T3-4
cannot be included in the same tolerable radiation program due to the widespread
distribution of multiple lung nodules or the large size of tumors / lymph nodes.
4. Four to six cycles of Durvalumab combined with standard chemotherapy (platinum +
etoposide) were evaluated as CR(complete response) or PR(partial response) before
entering the group.
5. Radiation oncologists determine that chest and oligometastatic lesions can be
treated with radiotherapy.
6. The age of diagnosis was 18 to 70 years old.
7. The Eastern Cooperative Oncology Group physical fitness score (PS score) was 0-1.
8. The function of bone marrow was normal: White blood cell count ≥ 3 × 10^9/L,
neutrophil count ≥ 1.5 × 10^9/L, hemoglobin concentration ≥ 90g/L, platelet count ≥
100 × 10^9/L.
9. Normal liver and kidney function: total bilirubin ≤ 1.5 times normal upper limit;
glutamic oxaloacetic transaminase and / or glutamic pyruvic transaminase ≤ 2.5 times
normal upper limit; alkaline phosphatase ≤ 2.5 times normal upper limit; creatinine
clearance ≥ 60 mL/min.
10. Life expectancy ≥ 12 weeks
Exclusion Criteria:
1. Within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is
the longer), systemic immune stimulants (including but not limited to interferon,
interleukin-2, tumor necrosis factor) are used (cancer vaccines are allowed in
previous treatments)
2. Within 14 days before the first administration of the drug, any Chinese herbal
medicine used to control cancer was used.
3. Any disease that must be treated with corticosteroids (prednisone > 10mg/ days or
equivalent) or other immunosuppressive drugs within 14 days before enrollment Note:
patients who have used or have used any of the following steroid regimens can be
selected: epinephrine replacement steroids (prednisone ≤ 10mg/ days or equivalent).
Inhaled corticosteroids with very low local, ocular, articular, nasal or systemic
absorption; prophylactic use of prescription corticosteroids in a short course (≤ 7
days) or for the treatment of non-autoimmune diseases (such as delayed anaphylaxis
caused by contact allergens)
4. Live vaccine is given within 4 weeks before joining the group. Note: seasonal
influenza vaccine is usually an inactivated vaccine, and patients who receive such
vaccine are allowed to join the group. The intranasal influenza vaccine is a live
vaccine, and patients vaccinated with such vaccine are not allowed to enter the
group.
5. Any major surgery requiring general anesthesia was performed within 28 days before
enrollment.
6. Previous allogeneic stem cell transplantation or organ transplantation
7. Clinically uncontrolled pericardial effusion or ascites requiring pleural or
abdominal puncture drainage within 2 weeks before randomization. Uncontrolled brain
metastasis with active leptomeningeal disease:
8. patients with asymptomatic central nervous system (CNS) metastasis during the
screening phase can be selected if all of the following conditions are met: brain
imaging examinations during the screening phase show that there is no evidence of
mid-term progression between completion of immunotherapy combined with chemotherapy
induction therapy and enrollment; no continuous use of corticosteroids for CNS
disease; and permitting stable doses of anticonvulsant therapy.
9. Suffer from active autoimmune diseases or have a history of autoimmune diseases that
may recur. Note: patients with the following diseases can be further screened:
well-controlled type 1 diabetic hypothyroidism (only thyroid hormone replacement
therapy can be controlled); well-controlled celiac disease; any other diseases that
do not require systemic treatment (such as vitiligo, psoriasis, alopecia) that are
not expected to recur without external triggers
10. Has suffered from interstitial lung disease or non-communicable pneumonia or
uncontrolled systemic diseases, including diabetes, hypertension, pulmonary
fibrosis, acute lung disease, etc.
11. Severe chronic or active infections that require systemic antibacterial, antifungal
or antiviral therapy within 2 weeks before enrollment, including, but not limited
to, tuberculosis
12. Any active malignant tumor less than 2 years before enrollment, except for specific
cancers examined in this study and any locally recurrent cancers that have been
cured (such as resected basal cell or squamous cell skin cancer, superficial bladder
cancer, cervical or breast carcinoma in situ)
13. Untreated chronic hepatitis B patients, chronic hepatitis B virus carriers with HBV
DNA ≥ 500 IU / mL (2500 copies / mL), active hepatitis C patients: patients with
inactive HBsAg carriers and patients with stable active HBV infection (HBVDNA < 500
IU/mL (2500 copies / mL)) after drug treatment can be enrolled. Only patients with
positive hepatitis B core antigen (anti-hepatitis B core antigen antibody) were
tested for HBVDNA. Patients who were negative for hepatitis C virus (HCV) antibody
during screening, or those who were positive for HCV antibody and then negative for
HCV RNA test during screening could be included in the study. Only hepatitis C virus
(HCV) antibody positive patients will be tested for HCVRNA. Note: patients who can
detect hepatitis B surface antigen (HBsAg) or HBVDNA should be treated in accordance
with treatment guidelines. Patients who received antiviral therapy at the time of
screening should have been treated for more than 2 weeks before joining the group
and continued treatment for 6 months after discontinuing the study drug treatment.
14. he known history of HIV infection 16. is 16. 5%. There are any of the following
cardiovascular risk factors: a. Cardiogenic chest pain occurred ≤ 28 days before
randomization, which was defined as moderate pain limiting instrumental activities
of daily life b. Symptomatic pulmonary embolism occurred ≤ 28 days before
randomization. There was any history of acute myocardial infarction less than 6
months before randomization. There was a history of heart failure in New York Heart
Association (NYHA) grade III or IV (Appendix 5) ≤ 6 months before randomization.
Ventricular arrhythmias with severity ≥ 2 occurred less than 6 months before
randomization. There was a history of cerebrovascular accident less than 6 months
before randomization. Uncontrolled hypertension: ≤ 28 days before randomization,
despite the use of antihypertensive drugs, systolic blood pressure ≥ 160 mmHg or
diastolic blood pressure ≥ 100 mmHg. Syncope or seizures occurred less than 28 days
before randomization.
15. Patients with side effects (due to previous anticancer therapy) did not return to
baseline or stable levels at the time of admission, except for adverse event (such
as hair loss, neuropathy and specific laboratory abnormalities) that could not pose
safety risks.
16. Has a history of severe hypersensitivity to other monoclonal antibodies.
19.Suffering from underlying diseases (including abnormal laboratory tests) or
alcohol or drug abuse or dependence, which are not conducive to the study of drug
administration or affect the interpretation of drug toxicity or adverse event, or
may lead to insufficient or reduced compliance with research behavior.
17. At the same time, he participated in another therapeutic clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
August 1, 2022
Completion date:
August 1, 2027
Lead sponsor:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Source:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05484583