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NCT05496166Not yet recruitingPhase 3

The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer

Comparing the Efficiency Between Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer: a Randomized, Controlled, Open-label, Single-center Phase III Clinical Trial

Source: ClinicalTrials.gov · Last updated 17 May 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To compare the efficiency between surgery and radiotherapy after SHR-1316 (Adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
348 (estimated)
First submitted
27 Jul 2022
Start date
1 Aug 2023
Primary completion date
1 Aug 2027
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Diseases
Lung cancer
NCT number
NCT05496166

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 348
  • From 1 Aug 2023 to the primary completion date, 1 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy;
  • Patients with other malignancies within five years prior to the start of the trial;
  • Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial;

Other illness

  • Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc;
  • With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy;
  • Allergy to the test drug;
  • Have or currently have interstitial lung disease;
  • Coexisting with HIV infection or active hepatitis;
  • Those who suffer from neurological diseases or mental illnesses who cannot cooperate;

Other

  • Pregnant or breastfeeding women;
  • Other reasons that investigators deem inappropriate for enrollment.

Who the study is looking for

  • after signing informed consent;
  • Aged 18-70;
  • Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;
  • For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.
  • Two thoracic surgeons assessed thar it would be able to achieve radical surgery or R0 resection after 4 cycles of treatment. Surgical approaches include lobectomy, sleeve resection and pneumonectomy
  • ECOG performance status score 0-1 points;
  • With a life expectancy of at least 12 weeks;
  • At least one measurable tumor
  • With normal Other major organs (liver, kidney, blood system, etc.) function:
    • Absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90 g/L. Note: Patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period;
    • \- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Serum total bilirubin ≤ 1.5×ULN (total bilirubin in patients with Gilbert syndrome must be \<3×ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN, or AST and ALT ≤5×ULN in patients with liver metastases
  • Female patients of childbearing potential must voluntarily use highly effective contraception during the study period until ≥ 120 days after the last dose of chemotherapy or SHR-1316, whichever is later, and have ≤ 7 days of urine or Serum pregnancy test results are negative;
  • Unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or SHR-1316, whichever is later.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
Shang'aiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.