Clinical trial NCT03628521: First-line Combination Treatment Based on Anlotinib
Official title: Anlotinib-based Combination as First-line Treatment in Advanced Non-small Cell Lung Cancer: a Single Center, Three Arms and Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lung Cancer
Advanced Stage
Keywords: lung cancer
first-line
combination
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore safety and therapeutic efficacy of anlotinib combined with erlotinib/chemotherapy/IBI308 as first-line treatment in advanced NSCLC patients. The primary endpoints of the study are safety and objective response rate (ORR);the secondary endpoints are disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).


Eligibility criteria: Inclusion Criteria:

1. Patients have voluntarily to join the study and give written informed consent for the study
2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
3. A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
4. Mutation status including EGFR, ALK ROS are explicit;
5. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
6. Patients did not receive systemic anti-cancer therapy previously, including traditional Chinese medicine.
7. Able to comply with study and follow-up procedures
8. Age ≥ 18 years and ≤ 75, ECOG PS: 0\~1, estimated survival duration more than 3 months;enough organ function;

8)Major organ function

1. For regular test results（no blood transfusion within 14 days）：

   1. Hemoglobin（HB）≥90g/L；
   2. Absolute neutrophils count（ANC）≥1.5×109/L；
   3. Blood platelets（PLT）≥80×109/L
2. Biochemical tests results defined as follows：

   1. Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ；
   2. Alanine aminotransferase（ALT）and aspartate aminotransgerase AST≤2.5ULN，liver metastases，if any，ALT和AST≤5ULN；
   3. Creatinine（Cr）≤1.5ULN or Creatinine Clearance rate (CCr)≥60 ml/min；
3. Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value(50%).

Exclusion Criteria:

1. Small cell lung cancer(including patients with mixed small cell lung cancer and non-small cell lung cancer) or central squamous cell carcinoma with cavity
2. Mutation status are unknown
3. Previously (within 5 years) or presently suffering from other malignancies,
4. Symptomatic or uncontrolled brain metastases
5. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication
6. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
7. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
8. Pregnancy or lactation
9. Previously treated including treated with traditional Chinese medicine
10. Patients who are allergic to any of the agent or any ingredient -

Primary outcomes:
measure: Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)
timeFrame: from initiation of treatment to 90 days after the treatment finished
measure: ORR
timeFrame: at the time of 8 weeks (2 cycles after treatment)
Secondary outcomes:
measure: DCR
timeFrame: at the time of 8 weeks (2 cycles after treatment)
measure: PFS
timeFrame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
measure: OS
timeFrame: From date of treatment until the date of death from any cause, assessed up to 50 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References:
citation: Chu T, Zhong R, Zhong H, Zhang B, Zhang W, Shi C, Qian J, Zhang Y, Chang Q, Zhang X, Dong Y, Teng J, Gao Z, Qiang H, Nie W, Zhao Y, Han Y, Chen Y, Han B. Phase 1b Study of Sintilimab Plus Anlotinib as First-line Therapy in Patients With Advanced NSCLC. J Thorac Oncol. 2021 Apr;16(4):643-652. doi: 10.1016/j.jtho.2020.11.026. Epub 2021 Jan 29.