Trial Title:
Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01)
NCT ID:
NCT06371482
Condition:
SCLC, Limited Stage
Conditions: Official terms:
Small Cell Lung Carcinoma
Durvalumab
Conditions: Keywords:
SCLC, Limited Stage
immunotherapy
chemoradiotherapy
Durvalumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
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
Description:
Durvalumab is an immunoglobulin G (IgG) 1-κsubtype monoclonal antibody (mAb) that blocks
the interaction of PD-L1 with PD-1 in T cells and CD80 (B7.1) in immune cells (ics).
Durvalumab is developed by Astrazeneca /MedImmune for the treatment of cancer. Durvalumab
is designed to reduce the cytotoxicity of antibody-dependent cells and complement
dependent cytotoxicity. In vitro studies have demonstrated that Durvalumab can antagonize
the inhibition of PD-L1 in human primary T cells, causing them to resume proliferation
and release interferon gamma (IFNγ). To date, more than 1,800 patients have been treated
with valiuzumab as a single agent or in combination with other cancer agents as part of
ongoing studies. Durvalumab: 10mg/Kg, intravenously, starting at week 7 every 3 weeks for
at least 1 year, or until progression, intolerance, or spontaneous withdrawal of the
patient.
Arm group label:
D with CRT
Intervention type:
Drug
Intervention name:
Chemotherapy drug of EP regimen
Description:
Etoposide: 80-100mg/m², intravenous infusion, given at week 1, 4, 7, 10, 13, 16, a total
of 6 cycles.
Carboplatin: AUC=5-6, intravenous infusion, given at weeks 1, 4, 7, 10, 13, 16, a total
of 6 weeks. Or cisplatin: 75-80mg/m2 intravenously, given at weeks 1, 4, 7, 10, 13, 16
for a total of 6 weeks.
Arm group label:
D with CRT
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
Radiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to
week 12 of radiotherapy.
Arm group label:
D with CRT
Summary:
This trial aims to assess efficacy and safety of durvalumab combined with
chemoradiotherapy for limited stage small cell lung cancer.
Detailed description:
Small cell lung cancer is a highly malignant tumor that accounts for about 15% of all
lung cancer types. The 5-year survival rate is less than 5%, and the overall survival of
patients who do not receive any antitumor therapy is only 2-4 months. In the past 40
years, 4 to 6 cycles of platinum-based chemotherapy, that is, etoposide combined with
cisplatin or carboplatin, has become the standard therapy for small cell lung cancer
patients and has been recommended by major global tumor treatment guidelines. While
initial response rates are as high as 70%, 80% of limited-stage patients and nearly all
patients with extensive stages are found to experience relapse or disease progression.
Current guidelines recommend that patients with limited stage small cell lung cancer
adopt the EP regimen combined with thoracic radiotherapy as the preferred treatment for
patients with limited stage small cell lung cancer. PD-L1 is part of a complex system of
receptors and ligands involved in controlling T cell activation. PD-L1 acts at multiple
sites in the body, releasing inhibitory signals to T cells via the PD-1 and CD80
receptors to help regulate the immune response. Durvalumab is an immunoglobulin G (IgG)
1-κsubtype monoclonal antibody (mAb) that blocks the interaction of PD-L1 with PD-1 in T
cells and CD80 (B7.1) in immune cells (ics). This trial aims to assess efficacy and
safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary participation and written signed informed consent;
- Age 18-75 years old, gender is not limited;
- Histologically or cytologically confirmed limited-stage small cell lung cancer (2009
AJCC/UICC/IASLC lung cancer TNM staging criteria, limited-stage SCLC is any T stage,
any N stage, and M0), and patients with suspected brain or bone metastasis at the
time of screening should undergo brain MRI or ECT before study enrollment;
- There are immunohistochemical results;
- Chemotherapy must include either cisplatin or carboplatin, in combination with
etoposide;
- Physical status score ECOG 0-1;
- Weight > 40 kg;
- Expected survival ≥ 6 months;
- According to RECIST 1.1 guidelines, at least one lesion (not previously receiving
radiotherapy) with a maximum diameter ≥ 10 mm as accurately measured by computed
tomography (CT) or magnetic resonance imaging (MRI) at baseline (except lymph nodes,
whose short axis must be ≥ 15 mm); And the lesion is suitable for repeated accurate
measurement.;
- No previous immunotherapy;
- no serious abnormalities of haematopoietic, cardiac, pulmonary, hepatic; and renal
functions and immunodeficiency (Haematology: white blood cells ≥3.5×109/L;
neutrophils ≥1.5×109/L; haemoglobin ≥90g/L; platelets
≥100×109/L. Liver and kidney function: total bilirubin ≤1.5 times the upper limit of
normal (ULN); AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal;
creatinine ≤1.5 times the upper limit of normal; albumin ≥30 g/L. Coagulation:
International Normalised Ratio (INR) or Prothrombin Time (PT) or Activated Partial
Thromboplastin Time (APTT)
≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, PT or INR is
acceptable as long as the PT or INR is within the range of the anticoagulant drug
formulation. Echocardiographic assessment: left ventricular ejection fraction (LVEF)
≥ low limit of normal (50%). Pulmonary function FEV1 ≥70% of % of predicted value
and DLCO ≥60% of % of predicted value).
- The female patient has evidence of postmenopausal status, or the urine or serum
pregnancy test results of the premenopausal woman are negative. Women who stop
menstruating for 12 months without other medical reasons are considered menopausal.
Exclusion Criteria:
- Distant organ metastases (excluding supraclavicular lymph nodes) as determined by CT
evaluation during screening and prior imaging;
- have received prior radiotherapy to the chest;
- have medical contraindications to etoposide - platinum (carboplatin or cisplatin)
based chemotherapy;
- having any active autoimmune disease or a history of autoimmune disease (e.g.
interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary gland inflammation,
vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be
included if hormone replacement therapy is effective), etc.), and a history of
immunosuppressive drug use within 28 days, with the exception of the use of hormones
for the purpose of dealing with toxicity from radiotherapy;
- Previously received or are receiving other PD-1 antibody therapy or other
immunotherapy targeting PD-1/PD-L1, or are currently participating in other
interventional clinical studies for treatment;
- Have received other anti-tumour therapy (including herbal therapy with anti-tumour
effect) within 4 weeks prior to the first dose of the study; have received long-term
systemic immunotherapy or hormone therapy (except physiological replacement therapy,
e.g., oral thyroxine for hypothyroidism) within 4 weeks prior to the first dose of
the study; and have been treated with other experimental drugs or interventional
clinical studies within 4 weeks prior to the first dose of the study;
- Patients with uncontrolled clinical cardiac symptoms or disease such as
(1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3)
myocardial infarction within 1 year, and (4) clinically significant supraventricular
or ventricular arrhythmias requiring clinical intervention;
- with congenital or acquired immune function defects (e.g., HIV-infected patients),
active hepatitis B (HBV-DNA ≥104 copies/ml) or hepatitis C (hepatitis C
antibody-positive with HCV-RNA above the lower limit of detection of the analytical
method), or active tuberculosis;
- Have an active infection or unexplained fever >38.5°C within 2 weeks prior to
screening (at the investigator's discretion, subjects may be enrolled for fever
arising from tumours);
- In the judgement of the investigator, the subject has other factors that may cause
him/her to be forced to terminate the study in the middle of the study, e.g.,
suffering from other serious illnesses (including psychiatric illnesses) that
require comorbid treatment, family or social factors that may affect the safety of
the subject or the collection of trial data.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Shen, PhD
Phone:
+86 15831183879
Email:
wbshen1979@sina.com
Contact backup:
Last name:
Hesong Wang, PhD
Phone:
+86 18810775196
Email:
wanghesongmz@163.com
Start date:
June 1, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06371482
