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First-line Combination Treatment Based on Anlotinib

Primary Purpose

Lung Cancer, Advanced Stage

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, first-line, combination

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

8)Major organ function

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
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；
Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value(50%).

Exclusion Criteria:

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
Mutation status are unknown
Previously (within 5 years) or presently suffering from other malignancies,
Symptomatic or uncontrolled brain metastases
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
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
Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
Pregnancy or lactation
Previously treated including treated with traditional Chinese medicine
Patients who are allergic to any of the agent or any ingredient -

Sites / Locations

Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

arm A

arm B

arm C

Arm Description

Anlotinib combined with erlotinib. Anlotinib will be given at a dose of 10mg once daily on days 1-14 of a 21-day cycle. Erlotinib will be given at a dose of 150mg once daily.

Anlotinib combined with chemotherapy. Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle. Pemetrexed (just for adenocarcinoma) will be given intravenously at a dose of 500mg per square meter of body surface area every 3 weeks; gemcitabine (just for squamous carcinoma) will be given intravenously at a dose of 1000mg per square meter of body surface area every 3 weeks; carboplatin will be given intravenously with a target area under the curve of 5 mg per milliliter per minute every 3 weeks.

Anlotinib combined with IBI308. Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle. IBI308 will be given intravenously at a dose of 200mg every 3 weeks.

Outcomes

Primary Outcome Measures

Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)

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)

Secondary Outcome Measures

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).

PFS

PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

OS is calculated from diagnosis to death or last follow-up time.

Full Information

NCT ID

NCT03628521

First Posted

August 7, 2018

Last Updated

August 9, 2018

Sponsor

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03628521

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 20, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Advanced Stage

Keywords

lung cancer, first-line, combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

arm A

Arm Type

Other

Arm Description

Anlotinib combined with erlotinib. Anlotinib will be given at a dose of 10mg once daily on days 1-14 of a 21-day cycle. Erlotinib will be given at a dose of 150mg once daily.

Arm Title

arm B

Arm Type

Other

Arm Description

Arm Title

arm C

Arm Type

Other

Arm Description

Anlotinib combined with IBI308. Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle. IBI308 will be given intravenously at a dose of 200mg every 3 weeks.

Intervention Type

Drug

Intervention Name(s)

Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)

Time Frame

from initiation of treatment to 90 days after the treatment finished

Title

ORR

Description

Time Frame

at the time of 8 weeks (2 cycles after treatment)

Secondary Outcome Measure Information:

Title

DCR

Description

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).

Time Frame

at the time of 8 weeks (2 cycles after treatment)

Title

PFS

Description

PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

Time Frame

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

Title

Description

OS is calculated from diagnosis to death or last follow-up time.

Time Frame

From date of treatment until the date of death from any cause, assessed up to 50 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients have voluntarily to join the study and give written informed consent for the study Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Mutation status including EGFR, ALK ROS are explicit; At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Patients did not receive systemic anti-cancer therapy previously, including traditional Chinese medicine. Able to comply with study and follow-up procedures Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;enough organ function; 8)Major organ function For regular test results（no blood transfusion within 14 days）： Hemoglobin（HB）≥90g/L； Absolute neutrophils count（ANC）≥1.5×109/L； Blood platelets（PLT）≥80×109/L Biochemical tests results defined as follows： Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ； Alanine aminotransferase（ALT）and aspartate aminotransgerase AST≤2.5ULN，liver metastases，if any，ALT和AST≤5ULN； Creatinine（Cr）≤1.5ULN or Creatinine Clearance rate (CCr)≥60 ml/min； Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value(50%). Exclusion Criteria: 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 Mutation status are unknown Previously (within 5 years) or presently suffering from other malignancies, Symptomatic or uncontrolled brain metastases 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 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 Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation Previously treated including treated with traditional Chinese medicine Patients who are allergic to any of the agent or any ingredient -

Facility Information:

Facility Name

Shanghai Chest Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Baohui Han, MD，PhD

Phone

+8618930858216

18930858216@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The data used or analyzed during the current study are available from the principle investigator on reasonable request after 6 months of the project is finished.

Citations:

PubMed Identifier

33524601

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.

Results Reference

derived

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First-line Combination Treatment Based on Anlotinib

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