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Non-small Cell Lung CancerPhase 2NCT03624309

Anlotinib Plus Docetaxel for the Treatment of EGFR Wild-type Advanced Non-small-cell Lung Cancer

A Phase 2 study testing Anlotinib Plus Docetaxel and Docetaxel in people with Non-small Cell Lung Cancer, run by Hunan Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Anlotinib Plus Docetaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
15 Oct 2018to 31 Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • signed and dated informed consent
  • diagnosed with advanced NSCLC (phase IIIB/IIIC/IV) through pathology, with measurable nidus(using RECIST 1.1)
  • have failed for platinum two drugs chemotherapy
  • EGFR wild type
  • ECOG PS：0-1,Expected Survival Time: Over 3 months
  • main organs function is normal
  • the woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 2 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 2 months after it

Who cannot join

  • Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
  • have used docetaxel before
  • have used antiangiogenic drugs （except Bevacizumab or endostatin）
  • have failed for two times or beyond of platinum two drugs chemotherapy（except adjunctive therapy，neoadjuvant therapy and concurrent chemoradiotherapy ）
  • iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor ; Or obvious lung empty or necrotic tumor
  • patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
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  • patients are participating in other clinical studies (other than non-interventional studies) less than 4 weeks from the end of a previous clinical study
  • other kinds of malignancies within 5 years or for now
  • have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  • abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
  • urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
  • uncontrollable hypertensive (systolic blood pressure or greater 150 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment)
  • the effects of surgery or trauma had been eliminated for less than 14 days before admission to the study group
  • patients with severe infections , and need to receive Systemic antibiotic treatment
  • significant cardiac disease as defined as: grade II or greater myocardial infarction, unstable arrhythmia(Including corrected QT interval (QTc )period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction （LVEF）Less than 50%
  • patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma
  • pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
  • serious, non-healing wound, ulcer, or bone fracture
  • decompensated diabetes or high dose glucocorticoid treatment of other contraindication
  • has an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
  • has Clinically significant hemoptysis Within 3 months before Random (daily hemoptysis than 50 ml;Or significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of fecal occult blood, or vasculitis, etc
  • has venous thromboembolism events Within 12 months before Random, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
  • whole body antitumor treatment was planned in the first 4 weeks(except diphosphonate) or during this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy， Chinese medicine with antitumor effect. Field scale radiotherapy (EF-RT) within 4 weeks before grouping or limited field radiotherapy before grouping were carried out in 6 months ;
  • a known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS)
  • untreated active hepatitis (hepatitis b: HBsAg positive and HBV DNA more than 1 x 103 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection
  • serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment

Trial locations and contacts

1 site in 1 country.

LIN WU, professor contact

008613170419973

wulin-calf@vip.163.com

China1 site, 1 recruiting

  • Hunan Cancer hospital

    Changsha, Hunan, 410000

    Recruiting

Other trials in China

About this study

Official title: Anlotinib Plus Docetaxel Versus Docetaxel for Treatment of EGFR Wild-type Advanced Non-small-cell Lung Cancer After Disease Progression on Platinum-based Therapy : a Multicentre, Double-blind, Randomised Explorative Trial

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore,we envisage using anlotinib plus docetaxel treat the EGFR wild-type advanced Non-small cell lung cancer patients who were failure in the treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

Read the detailed description

This is a multicentre randomised controlled clinical trial conducted in China to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR wild-type Advanced Non-squamous Non-small Cell Lung Cancer.

Eligible patients will be randomized to arm A and arm B:

Arm A: Patients on the anlotinib and docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle and 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle.

Arm B: Patients on the docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle.

Being tested
Anlotinib Plus Docetaxel, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Anlotinib Plus DocetaxelDrug

    Also called Anlotinib & Docetaxel

    Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)

  • DocetaxelDrug

    Docetaxel (75mg/m2 IV d1)

Study groups in NCT03624309
Study groupRoleWhat they receive
Anlotinib Plus DocetaxelExperimentalAnlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
Receives: Drug: Anlotinib Plus Docetaxel
DocetaxelActive comparatorDocetaxel (75mg/m2 IV d1)
Receives: Drug: Docetaxel

What is being measured

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

  1. PFS

    Progress free survival

    Measured: each 42 days up to PD or death(up to 24 months)

Secondary outcomes (4)

  1. OS

    Overall Survival

    Measured: From randomization until death (up to 24 months)

  2. ORR

    Objective Response Rate

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  3. DCR

    Disease Control Rate

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  4. Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Until 21 day safety follow-up visit

Timeline

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

  1. First posted10 Aug 2018
  2. Study start15 Oct 2018
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion31 Dec 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624309
Sponsor's protocol ID
ALTER-L018
Status last verified
Jan 2020
First submitted
5 Aug 2018
Last updated
7 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pu X, Shou J, Xiao Z, Chen J, Xiao M, Guo Q, Ma Z, Hong W, Wang Q, Wang Y, Li J, Rao C, Weng J, Lu L, Wu L, Fang Y. Anlotinib Plus Docetaxel is Promising in Advanced NSCLC Progressing on First-Line Immunotherapy: A Pooled Analysis of Two Randomized Trials. Adv Ther. 2025 Jul;42(7):3249-3264. doi: 10.1007/s12325-025-03170-2. Epub 2025 May 12.

    PubMed 40354010

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib Plus Docetaxel and Docetaxel in people with Non-small Cell Lung Cancer, run by Hunan Cancer Hospital 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 7 inclusion and 26 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 7 Jan 2020. 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 LIN WU, professor (008613170419973, wulin-calf@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: each 42 days up to PD or death(up to 24 months)). 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 NCT03624309, 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 7 Jan 2020.

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