Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Advanced or Metastatic Non-small Cell Lung Cancer Patients : a Phase II, Historical Control, Biomarker-selected Study
Overview
- Phase
- Phase 2
- Intervention
- Sintilimab
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- China Medical University, China
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Progress free survival (PFS)
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to to explore the efficacy and safety of PD-1 immune check point inhibitor, sintilimab, in biomarker-selected subjects with advanced or metastatic Non-small Cell Lung Cancer who have failed from standard front-line treatment.
Detailed Description
This study is planned to be carried out in The First Hospital of China Medical University. 33 cases are preliminarily expected to be included. The study started in October 2020 and ended in October 2023. It is expected that the trial will end in October 2023. In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.
Investigators
Yunpeng Liu
Director of Department of Medical Oncology
China Medical University, China
Eligibility Criteria
Inclusion Criteria
- •≥ 18 and ≤ 70 years of age , regardless of gender；
- •Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC (according to the eighth edition of AJCC staging, IIIB, IIIC, IV), with at least one measurable lesion (RECIST 1.1)
- •treatment failure after first-line standard treatment (definition of treatment failure: intolerable side effects, disease progression during or after treatment);
- •No known EGFR sensitive mutations and ALK gene rearrangements.
- •Tumor tissue samples that meet the testing requirements for biomarker testing can be provided. Testing will be carried out in the central laboratory.
- •NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive(TPS PD-L1 expression is ≥1% ), and CD8 expression is ≥20% (pre-treatment samples are sufficient).
- •ECOG PS: 0-1
- •Sufficient organ and bone marrow function as defined below:
- •Routine blood examination:
- •ANC ≥1.5×109/L;
Exclusion Criteria
- •Allergic to any ingredients of Sintilimab preparations; or have had severe allergic reactions to other monoclonal antibodies in the past.
- •Received more than one regimen for the treatment of locally advanced or metastatic NSCLC in the past (except for adjuvant/neoadjuvant chemotherapy that has exceeded the 24-week).
- •Received any anti-PD-1/PD-L1 antibody, anti-CTLA4 antibody, or other immunotherapy in the past.
- •Diagnosed other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma and/or radically excised carcinoma in situ.
- •Be treated with anti-tumor vaccines or other immunostimulatory anti-tumor drugs (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before enrolled.
- •Central nervous system metastasis with symptoms..
- •Acute or chronic active hepatitis B (defined as positive for hepatitis B virus surface antigen HBsAg during the screening period) or hepatitis C infection.
- •History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases.
- •Active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before the first administration.
- •People infected with human immunodeficiency virus (HIV) (HIV antibody positive), people with known syphilis infection.
Arms & Interventions
Treatment
Participants received Sintilimab, 200mg, iv, d1, Q3W,and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Intervention: Sintilimab
Outcomes
Primary Outcomes
Progress free survival (PFS)
Time Frame: untill Progressive Disease(PD) or death(up to 24 months)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Secondary Outcomes
- Overall Survival (OS)(From randomization until death (up to 24 months))
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))