NCT03983928Unknown1 期
A Phase Ib, Open-label, Single Center, Non-randomized Study for Safety and Efficacy of TQB2450 Combined With Anlotinib in Subjects With Advanced Mutation Positive Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response rate （ORR）
研究概览
简要总结
This is an open-label, single center, non-randomized, phase Ib trial to evaluate safety and efficacy of TQB2450 injection combined with anlotinib in patients with advanced mutation positive non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understood and signed an informed consent form.
- •18 years and older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
- •Histologically or cytologically confirmed mutation positive non-small cell lung cancer according to 8th International Association for the Study of Lung Cancer (IASLC) edition.
- •Has measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Adequate organ system function, defined as follows:
- •absolute neutrophil count (ANC) ≥ 1.5×10^9/L, platelets (PLT) ≥ 100×10^9/L, hemoglobin (Hb)≥ 90g /L;
- •total bilirubin (TBIL) ≤ 1.5×ULN；alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN (without liver metastasis) or ≤ 5.0 × ULN (with liver metastasis), Creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 ml/min;
- •Urine protein < ++，or urine protein ≥ ++ concomitant with content of 24-hour urinary protein <1.0 g;
- •international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
- •left ventricular ejection fraction (LVEF) ≥ 50%;
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
排除标准
- •Has diagnosed and/or treated additional malignancy within 5 years prior to randomization except of cured in situ carcinoma of the cervix, non-melanoma skin cancer and superficial bladder carcinoma.
- •Has severe hypersensitivity reactions after taking other monoclonal antibodies.
- •Has hypersensitivity reactions after taking anlotinib.
- •Has prior therapy with anlotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or other immunotherapy against PD-1/PD-L
- •Has any active autoimmune disease or history of autoimmune disease, such as autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis, asthma patients who need bronchiectasis for medical intervention; Subjects with the vitiligo without systemic treatment, psoriasis, alopecia, well-controlled type I diabetes mellitus, hypothyroidism stable on hormone replacement will not be excluded from this study.
- •Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
- •Has clinical significance of thyroid dysfunctions within 6 months prior to enrollment, and even though medical therapy, thyroid function can not return to normal or no clinical significance.
- •Has central nervous system (CNS) metastases without local therapy of lesion.
- •Radiograph (within 28 days before enrollment) showed that the tumor surrounded important blood vessels, and the investigators determined that entering the study would cause bleeding risk.
- •Hemoptysis (defined as coughing out or spitting out ≥ 1 teaspoon of blood or small blood clots or hemoptysis without sputum) within 28 days before enrollment , not including bloody sputum.
- •Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
- •Has any of the following severe acute complications:
- •Unstable angina and/or congestive heart failure or vascular disease requiring hospitalization within 12 months, or other cardiac impairments determined by the investigator, which may affect the evaluation of drug safety; Myocardial infarction or ischemia with ST elevation ≥ 2 mm indicated by electrocardiogram (ECG);
- •Has pulmonary infections and/or acute bacterial or fungal infections requiring intravenous antibiotic therapy;
- •Has clinical jaundice caused by liver dysfunction;
- •Virological test indicates one of the following items before enrollment:
- •HBsAg positive and HBV DNA ≥ 1 × 10^3 copies/mL;
- •Anti-HCV positive and HCV virus titer detection value exceeds the upper limit of normal value;
- •HIV positive;
- •Has participation in an anti-tumor clinical trial within 28 days prior to the first administration.
- •Has serious affecting safety or treatment compliance concomitant diseases, according to the investigator's judgment.
研究组 & 干预措施
TQB2450 Combined with Anlotinib
Experimental
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
干预措施: TQB2450 (Drug)
TQB2450 Combined with Anlotinib
Experimental
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
干预措施: Anlotinib (Drug)
结局指标
主要结局
Overall response rate （ORR）
时间窗: up to approximately 12 months
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
次要结局
- Overall survival (OS)(up to approximately 15 months)
- Disease control rate（DCR）(up to approximately 12 months)
- Progression-free survival (PFS)(up to approximately 12 months)
研究者
研究点 (1)
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