First-line Combination Treatment Based on Anlotinib

Lung Cancer Clinical Trial

Official title:

Anlotinib-based Combination as First-line Treatment in Advanced Non-small Cell Lung Cancer: a Single Center, Three Arms and Exploratory Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03628521
• Other study ID #: ACTION
• Status: Recruiting
• Phase: Phase 1
• Start date: July 20, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2018
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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?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 -

Related Conditions & MeSH terms

• Advanced Stage
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Anlotinib,Erlotinib,IBI308,Pemetrexed,gemcitabine,carboplatin
Patient harboring EGFR mutation will be enrolled into arm A. Patients without sensitive EGFR mutation will be assigned to either arm B or arm C based on patients' or treating physicians'choice

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)		from initiation of treatment to 90 days after the treatment finished
Primary	ORR	Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)	at the time of 8 weeks (2 cycles after treatment)
Secondary	DCR	Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).	at the time of 8 weeks (2 cycles after treatment)
Secondary	PFS	PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.	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
Secondary	OS	OS is calculated from diagnosis to death or last follow-up time.	From date of treatment until the date of death from any cause, assessed up to 50 months