Kemoterapi Başarısız Olmuş İlerlemiş NSCLC için Sintilimab ile Docetaxel Kombinasyonu Üzerine Faz II Çalışma: SUCCESS Çalışması

Sade dilde özet

Bu çalışma, önceki kemoterapinin başarısız olduğu ilerlemiş küçük hücreli dışı akciğer kanseri (non-small cell lung cancer, NSCLC) olan hastalarda Sintilimab ile Docetaxel kombinasyonunu değerlendirmektedir. Çalışmaya, platin içeren ikili kemoterapiden sonra hastalığı ilerlemiş, EGFR, ALK veya ROS1 hedefli tedaviye uygun olmayan, 18-75 yaş arası hastalar katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Hunan Province Tumor Hospital

Müdahale

Sintilimab Combined With Docetaxel

Başlangıç

01.01.2019

Tahmini bitiş

01.03.2022

Ülkeler

China

İlgili genler

Merkezler

• Changsha, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Sign written informed consent before any trial-related processes are implemented
* Age ≥ 18 years old and ≤ 75 years old
* Life expectancy exceeds 3 months
* The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard
* Histological or cytological diagnosis of NSCLC and stage IIIB/IV stage tumors (according to the International Association for the Study of Lung Cancer)Chest tumor staging manual 8th edition judgment) or in multimodal treatment (radiotherapy, surgical resection or radical chemoradiotherapy local treatment)Subjects with relapse or disease progression after treatment for locally advanced disease.
* Subjects must have previously been treated with a platinum-containing dual chemotherapy (carboplatin or cisplatin) regimen for advanced or metastatic tumorsisease progression occurred during or after the period.

  i) receiving maintenance therapy (referring to treatment with no progress after treatment with a platinum-containing dual chemotherapy regimen) and progress Subjects are eligible for inclusion. Ii) treatment of locally advanced disease with platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy, and completion of treatment Subjects with tumor recurrence or metastasis within 6 months after treatment are eligible.selected.

Iii) administration of platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy for treatment of locally advanced disease \>6 months laterTumor recurrence, and later progressed during or after treatment of a recurrent tumor with a platinum-based regimen Subjects are eligible for inclusion.

* Patients confirmed by histological specimens who are not eligible for EGFR, ALK or ROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK, ROS1 gene rearrangement);
* The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1
* Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin≥90g/L \[no blood transfusion or erythropoietin (EPO) within 7 days\] Dependency\];
* Good liver function, defined as total bilirubin level ≤ normal upper limit (ULN); patients without liver metastases, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 1.5 times ULN, alkaline phosphatase ≤ 2.5 times ULN For patients with recorded liver metastases, AST and ALT levels ≤ 5 times ULN;

Exclusion Criteria:

* Small cell lung cancer
* Currently participating in interventional clinical research treatment, or receiving other research medications within 4 weeks prior to the first dose or Used research equipment;
* Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulus or association a drug that inhibits T cell receptors (eg, CTLA-4, OX-40, CD137);
* Systemic systemic treatment of Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use of pleural effusion) with anti-lung cancer indications within 2 weeks prior to the first dose, or before the first dose Major surgical treatment within 3 weeks;
* Pulmonary radiation therapy \>30 Gy within 6 months prior to first dose
* Completed palliative radiotherapy within 7 days prior to the first dose