Combining Durvalumab with Chemoradiotherapy for Limited Stage Small Cell Lung Cancer
Official title: Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer
Run by Hebei Medical University Fourth Hospital · NCT06371482 · Data updated 2026-11-12
This study is testing if adding the immunotherapy drug durvalumab to standard chemotherapy and radiation can help people with limited stage small cell lung cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | Chemotherapy, immunotherapy, durvalumab |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | December 31, 2024 |
| Study ends | December 31, 2027 |
| Registry record updated | June 17, 2024 |
| Trial ID | NCT06371482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with histologically confirmed limited stage small cell lung cancer and an ECOG performance status of 0-1.
✕Probably not a fit
Patients with extensive stage small cell lung cancer or those with significant comorbidities that affect treatment tolerance may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the safety and efficacy of durvalumab, an immunotherapy drug, when combined with chemoradiotherapy for patients with limited stage small cell lung cancer (SCLC). Small cell lung cancer is a highly aggressive form of lung cancer with a poor prognosis, and current treatments often lead to relapse. The study aims to improve outcomes by utilizing durvalumab to enhance the immune response against the cancer. Participants will receive the standard chemotherapy regimen along with radiotherapy and durvalumab to assess treatment effectiveness.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with limited stage small cell lung cancer.
How similar studies have gone: While the combination of immunotherapy and chemoradiotherapy is a novel approach in this specific context, similar strategies have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Recruiting
Study contacts
- Principal investigator: Wenbin Shen, PhD — Hebei Medical University Fourth Hospital
- Study coordinator: Wenbin Shen, PhD
- Email: wbshen1979@sina.com
- Phone: +86 15831183879
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer
This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.
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Durvalumab with FLOT before and after surgery for resectable gastric/GEJ cancer in Chinese patients
This trial tests whether adding durvalumab to FLOT chemotherapy before and after surgery helps Chinese patients with resectable gastric or gastroesophageal junction cancer.
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This study tests whether adding zolbetuximab to FLOT chemotherapy plus durvalumab can improve tumor response before surgery in adults with CLDN18.2-positive gastric or GEJ cancer.
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Tislelizumab plus Anlotinib after chemoradiotherapy in limited-stage SCLC
This phase II trial tests whether adding tislelizumab and anlotinib after chemoradiotherapy helps people with limited-stage small cell lung cancer stay cancer-free.
-
Alternating chemo-immunotherapy and FGFR inhibitor for FGFR-positive biliary tract cancer
This phase 2 trial tests whether alternating gemcitabine/cisplatin with durvalumab and the FGFR2 inhibitor pemigatinib can help people with unresectable or metastatic biliary tract cancers that have FGFR alterations.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.