A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 7
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is an open, multi-cohort, exploratory phase II study on the safety and efficacy of TQB3616 combined with Anlotinib hydrochloride capsules or standard chemotherapy in the treatment of advanced lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects with pathologically proven small cell lung cancer(SCLC) or/and locally advanced ( Stage ⅢB/ ⅢC), metastatic or recurrent (Stage IV) non small cell lung cancer(NSCLC).
- •Cohort 1: Subjects with SCLC who had previously received at least one chemotherapy containing platinum or got disease progression during chemoradiotherapy or after the last treatment.
- •Cohort 2: Subjects with locally advanced, metastatic/relapsed NSCLC who had previously received only one PD (L) 1 inhibitor alone or in combination with platinum-based chemotherapy.
- •Subjects with measurable lesions as defined by RECIST 1.
- •Aged ≥ 18 years ; Eastern Cooperative Oncology Group (ECOG) score: 0 ~ 1; Expected survival ≥ 3 months.
- •Laboratory indicators meet the requirements.
- •Non-pregnant or non-breastfeeding women; Negative pregnancy subjects.
- •Subjects voluntarily joined the study and signed the informed consent form.
排除标准
- •Subjects who received prior therapy with anlotinib hydrochloride capsules.
- •Cohort 2: Subjects with epidermal growth factor receptor(EGFR) mutation and anaplastic lymphoma kinase(ALK) translocation.
- •Subjects with central squamous cell carcinoma with a risk of hemoptysis.
- •Subjects who have developed or is currently suffering from other malignancies within 5 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ.
- •Subjects who have brain metastases with symptoms or control of symptoms for less than 2 months.
- •Subjects with difficulty taking oral medication.
- •Subjects with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- •Subjects with spinal cord compression who have failed to be cured or relieved by surgery and or radiotherapy.
- •Subjects who have received chemotherapy, radiotherapy or other experimental anticancer therapy within 4 weeks prior to the first dose of the drug.
- •Subjects who have not recovered to ≤ CTCAE Grade 1 (excluding alopecia) due to the adverse event of prior therapy.
- •Subjects with significant surgery or significant traumatic injury within 28 days before randomization.
- •Subjects with arterial/venous thrombosis within 6 months.
- •Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.
- •Subjects with any severe and/or uncontrolled disease.
- •Subjects whose large vessels are involved by tumor from imaging (CT or MRI).
- •Subjects who have hemoptysis and maximum daily hemoptysis ≥ 2.5ml within 1 month before the first dose.
- •Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.
研究组 & 干预措施
TQB3616 capsules+Anlotinib hydrochloride capsules
TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 21 consective days as a treatment cycle;Anlotinib hydrochloride capsules 12mg, once a day for 2 consecutive weeks and stop for 1 week.
干预措施: TQB3616 capsules (Drug)
TQB3616 capsules +Irinotecan Hydrochloride for Injection
TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 28 consecutive days as a treatment cycle. Irinotecan Hydrochloride Injection 100 mg/m2 intravenous infusion on D1、D8 and D15, a total of 4-6 cycles.
干预措施: TQB3616 capsules (Drug)
TQB3616 capsules+Anlotinib hydrochloride capsules
TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 21 consective days as a treatment cycle;Anlotinib hydrochloride capsules 12mg, once a day for 2 consecutive weeks and stop for 1 week.
干预措施: Anlotinib Hydrochloride capsules (Drug)
TQB3616 capsules +Irinotecan Hydrochloride for Injection
TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 28 consecutive days as a treatment cycle. Irinotecan Hydrochloride Injection 100 mg/m2 intravenous infusion on D1、D8 and D15, a total of 4-6 cycles.
干预措施: Irinotecan Hydrochloride for Injection (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
次要结局
- 6-month and 12-month overall survival rate(up to 96 weeks)
- Duration of Response (DOR)(up to 120 weeks)
- 6-month progression-free survival rate(up to 96 weeks)
- Disease control rate（DCR）(up to 96 weeks)
- Progression-free survival (PFS)(up to 96 weeks)