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NSCLCPhase 2NCT03416231

Apatinib Plus Docetaxel in Advanced Non-squamous Non-small Cell Lung Cancer(NSCLC)

A Phase 2 study testing Apatinib and Docetaxel in people with NSCLC, run by Affiliated Hospital of North Sichuan Medical College at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study was to evaluate the effectiveness and safety of apatinib combined with docetaxel in NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
What is being tested?
Apatinib and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
30 Nov 2016to 1 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male or female patients, age: ≥ 18 years of age;
  • 2. Pathologically diagnosed late (stage IIIB, stage IV, see Annex 1) non-squamous non-small cell lung cancer with measurable lesions (CT scan of tumor lesion longer than 10 mm in diameter, shorter than 15 CT scan of lymph nodes mm, the scanning layer thickness is not more than 5 mm;
  • 3. Previous drug treatment consisted of a platinum-based chemotherapy regimen (> 1 chemotherapy regimen) for relapse or failure of treatment.
  • 4. The main organs function properly, that is, within 14 days prior to the relevant indicators meet the following requirements:(1) a. Hemoglobin (HB) ≥90 g / L; (no blood transfusion within 14 days):b. neutrophil count (ANC) ≥ 1.5 × 109 / L; c. Platelet count (PLT) ≥80 × 109 / L;(2) biochemical tests to meet the following criteria:a. Total bilirubin (TBIL) <1.5?ULN (upper limit of normal);b. Blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
  • 5. Sign the inform consent form with good compliance.

Who cannot join

  • 1. Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma)
  • 2. Patients who had previously received docetaxel treatment were excluded
  • 3. Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms).
  • 4. Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).
  • 5. Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).
  • 6. According to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
Show all 27Show fewer
  • 7. Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
  • 8. Patients treated with anticoagulation agents or Vitamin K antagonist such as Warfarin, heparin, or other similar drugs.
  • 9. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above.
  • 10. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc.
  • 11. Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening.
  • 12. Known genetic or acquired bleeding or bleeding tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, and hypersplenism, etc.).
  • 13. Patients who have unhealed wounds or fractures for a long time.
  • 14. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening.
  • 15. Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc.
  • 16. Occurrence of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months before screening.
  • 17. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
  • 18. Patients with active hepatitis B virus or hepatitis c virus infection.
  • 19. Active infection requiring antimicrobial treatment, such as antibacterial, antifungal, or antiviral therapy.
  • 20. Patients with clinical symptoms, or dropsy of serous cavity requiring surgical treatment (including hydrothorax, ascites, and hydropericardium).
  • 21. Patients who have a history of psychotropic drug abuse and are unable to break the habit, or who have a psychogeny.
  • 22. Patients who have taken part in other drug clinical tests within 4 weeks before screening.
  • 23. Prior VEGFR inhibitor treatment.
  • 24. Patients who formerly suffered from or currently are complicated with other uncured malignant tumors, except basal cell carcinoma, carcinoma in situ of cervix and superficial bladder cancer that have been cured.
  • 25. Patients who received the treatment with potent CYP3A4 inhibitors within 7 days before screening, or potent CYP3A4 inducers within 12 days before being included.
  • 26. Pregnant or lactating women, fertile patients who are unwilling or unable to take effective contraceptive measures.
  • 27. Conditions determined by investigators to possibly affect the clinical study or determination of the study results.

Trial locations and contacts

1 site in 1 country.

Daiyuan Ma, M.D contact

868172246171

angenpn@gmail.com

China1 site, 1 recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 600000

    Daiyuan Ma, M.D, 868172246171, angenpn@gmail.com

    xin hu, M.D

    Recruiting

Other trials in China

About this study

Official title: A Study of Combined Treatment of Apatinib With Docetaxel as Post Second-line Therapy in Advanced Non-squamous Non-small Cell Lung Cancer(NSCLC)

The purpose of this study was to evaluate the effectiveness and safety of apatinib combined with docetaxel in NSCLC.

Conditions
NSCLC
Being tested
Apatinib, Docetaxel
Keywords
apatinib, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Also called Aitan

    apatinib, at a dose of 250 mg daily,Treatment was continued until disease progression.

  • DocetaxelDrug

    Docetaxel, at a dose of 75mg/m2 on days 1 and 22, repeat every 4 weeks for 4~6 cycles.

Study groups in NCT03416231
Study groupRoleWhat they receive
apatinib plus docetaxelExperimentalapatinib combine with docetaxel， 4~6 cycles
Receives: Drug: Apatinib; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate (ORR)

    Proportion of patients with reduction in tumor burden of a predefined amount

    Measured: 6 month

Secondary outcomes (3)

  1. progression free survival (PFS)

    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

    Measured: 12 month

  2. disease control rate (DCR)

    Disease Control Rate (DCR) and Clinical Benefit Rate (CBR) are defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.

    Measured: 6 month

  3. 6-month overall survival rate

    6-month overall survival rate

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2018
  2. Study start30 Nov 2016
  3. Primary completion1 Jan 2019 (estimated)
  4. Study completion1 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03416231
Sponsor's protocol ID
APTN-ANSCLC-2017-001
Status last verified
Jan 2018
First submitted
24 Jan 2018
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jiang Q, Zhang NL, Ma DY, Tan BX, Hu X, Fang XD. Efficacy and safety of apatinib plus docetaxel as the second or above line treatment in advanced nonsquamous NSCLC: A multi center prospective study. Medicine (Baltimore). 2019 Jun;98(26):e16065. doi: 10.1097/MD.0000000000016065.

    PubMed 31261514

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and Docetaxel in people with NSCLC, run by Affiliated Hospital of North Sichuan Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daiyuan Ma, M.D (868172246171, angenpn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03416231, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018; AzTrials last refreshed its copy on 2 Nov 2026.

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