Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in NSCLC

NCT03256721 | Terminated Phase 2

• 1 other identifier: SECGOLC003
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus chemotherapy drug can improve progression free survival compared with chemotherapy drug in patients with metastatic the non-small cell lung cancer who failed one lines of chemotherapy.

Conditions

Nonsmall Cell Lung Cancer

Keywords

apatinib docetaxel pemetrexed

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  To compare progression-free survival (PFS) in subjects treated with apatinib plus chemotherapy drug versus chemotherapy drug as a second-line treatment in whom with advanced or metastatic non-small cell lung cancer (NSCLC)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Study Arms (2)

Apatinib+docetaxel/pemetrexed

EXPERIMENTAL

Apatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d

Drug: Apatinib/docetaxel/pemetrexed

docetaxel/pemetrexed

ACTIVE COMPARATOR

docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d

Drug: docetaxel/pemetrexed

Interventions

Apatinib/docetaxel/pemetrexed DRUG

Participants are randomly assigned to treatment group or control group

Apatinib+docetaxel/pemetrexed

docetaxel/pemetrexed DRUG

Participants are randomly assigned to treatment group or control group

docetaxel/pemetrexed

Eligibility Criteria

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

You may qualify if:

• Age：18\~75 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC who have previously received no more than one lines treatment before participating；
• Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI .
• EGFRˉ,and ALK mutation in the negative or unknown；
• Subjects without brain metastases or asymptomatic brain metastases, and not needing for dehydrating agents or corticosteroids to control intracranial symptoms;
• Survival expectation≥ 3 months;
• The main organ function is normal;
• Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative.
• Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol

You may not qualify if:

• Small Cell Lung Cancer;
• Subjects with symptomatic brain metastases;
• Survival expectation \< 3 months;
• Blood transfusion is required in the first dose of drug treatment within 14 days ;
• The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other anticancer therapies in the first dose of drug treatment within 21 days(excluding palliative radiotherapy);
• The risk of active bleeding;
• Subjects with uncontrolled blood pressure with medication (140/90 mmHg)
• Laboratory values and organ functions ： （1）Hematologic insufficiency:
• Hemoglobin (Hb)\<8.5 g/dL，
• Absolute neutrophil count (ANC)≤1.5×109/L，
• Platelet count (PLT)\< 100×109/L； （2）Insufficient liver function:
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• Bilirubin \> 1.5×the upper limit of normal (ULN)
• Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) \>3.0×(ULN), When liver metastases,Bilirubin \> 1.5×ULN, ALT or AST \>5.0×(ULN.
• serum creatinine ≤1.0×（ULN）, or creatinine clearance \> 50 mL/min( calculated per the Cockcroft and Gault formula) (3) Subjects with positive for HBV surfaceantigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease (5)Insufficient renal function: serum creatinine≥ 1.5×（ULN）, or creatinine clearance \<60 mL/min

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Fuzhou general hospital

Fuzhou, Fujian, 365000, China

Location

Related Publications (1)

• Yu Z, Cai X, Xu Z, He Z, Lai J, Wang W, Zhang J, Kong W, Huang X, Chen Y, Shi Y, Shi X, Zhao Z, Ni M, Lin X, Chen S, Wu X, Chen W, Song Z, Huang C. Apatinib plus Chemotherapy as a Second-Line Treatment in Unresectable Non-Small Cell Lung Carcinoma: A Randomized, Controlled, Multicenter Clinical Trial. Oncologist. 2020 Nov;25(11):e1640-e1649. doi: 10.1634/theoncologist.2020-0519. Epub 2020 Jul 25.

  PMID: 32533785 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinib; Docetaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A: Apatinib 500mg QD PO d1-21 + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d Group B: Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: August 16, 2017
• Primary Completion: March 27, 2019
• Study Completion: August 16, 2019
• Last Updated: February 8, 2021

Record last verified: 2018-08

Locations

CN (1)