First-line Combination Treatment Based on Anlotinib

NCT03628521 | Unknown Phase 1 DMC

• 1 other identifier: ACTION
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Cancer; Advanced Stage

Keywords

lung cancer; first-line; combination

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• DCR

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

• PFS

  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

• OS

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

Study Arms (3)

arm A

OTHER

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.

Drug: Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin

arm B

OTHER

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.

Drug: Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin

arm C

OTHER

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.

Drug: Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin

Interventions

Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin DRUG

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

arm A; arm B; arm C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• )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) ；

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33524601 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: July 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

CN (1)