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Unresectable Stage III Non-small Cell Lung CancerPhase 2NCT04111913

A Study of Sequential Anlotinib Followed by EP Regimen Plus Concurrent Radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer

A Phase 2 study testing Anlotinib Hydrochloride in people with Unresectable Stage III Non-small Cell Lung Cancer, run by Nanfang Hospital, Southern Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Anlotinib Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Oct 2019to 31 Aug 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
  • ≥ 18 and ≤ 70 years of age within male and female.
  • Histologically confirmed，locally advanced NSCLC of stage IIIA/IIIB.
  • Unresectable stage IIIA and stage IIIB with pathological evidence of the following images or lymph nodes:
  • Multiple metastases of the mediastinal lymph nodes are transferred into a massive mass or multiple sites (IIIA: T1-3N2 or IIIB: T4N2)
  • Contralateral hilar, mediastinal lymph nodes, or the same, contralateral scalene or supraclavicular lymph node metastasis (IIIB: T1-4N3)
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  • The lesion invades the heart, aorta and esophagus (IIIB: T4N0-1)
  • Life expectancy of more than 3 months.
  • Eastern Cooperative Oncology Group(ECOG)performance scale 0-1.
  • Weight loss ≤5% in the last 3 months since enrollment.
  • Good lung function (predicted FEV1 ≥1 liter), no history of bronchial pneumonia, tracheobronchial disease and upper respiratory tract bleeding.
  • None previous chemotherapy or targeted therapy.
  • Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 90 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1.25 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 45ml/min.
  • For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.

Who cannot join

  • small cell lung cancer (including small cell and non-small cell mixed lung cancer).
  • Radiologically documented evidence of tumor lesions from large vessels ≤ 5mm or major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor.
  • History and complication:
  • Less than 4 weeks from the last clinical trial or participating in other clinical studies.
  • Other active malignancies that require simultaneous treatment.
  • History of malignancy except cured basal cell skin cancer, or carcinoma in situ of the cervix, or superficial bladder cancer.
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  • Patients with previous anti-tumor treatment-related adverse reactions (excluding hair loss) did not return to NCI-CTCAE ≤ 1 level.
  • Coagulation disfunction（INR>1.5 or PT>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) >1.5 Upper Limit Of Normal(ULN)）, hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation.
  • Renal insufficiency. Urine protein≥++, and 24h urine protein quantitation≥1.0g.
  • Patients had major surgery or severe trauma before enrollment. The effects of surgery or trauma have been eliminated for less than 14 days.
  • Severe acute or chronic infection requiring systemic treatment.
  • Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%.
  • Peripheral neuropathy with ≥CTCAE 2 degrees currently present, except for trauma.
  • Respiratory syndrome (≥CTC AE grade 2 dyspnea).
  • Symptomatic serous effusion requiring treatment .(including hydrothorax, ascites, hydropericardium)
  • Long-term untreated wounds or fractures（in addition to tumor-induced pathological fractures).
  • Decompensated diabetes or other remedies for high-dose glucocorticoid therapy.
  • Significant factors that influence the ingestion and absorption of medicine, (e.g. unable swallow, chronic diarrhea and intestinal obstruction.
  • Clinically significant hemoptysis occurred within 3 months prior to enrollment (daily hemoptysis greater than 50 ml). History of clinically relevant major bleeding event=<3 months (e.g. gastrointestinal hemorrhage, Hemorrhagic acne， bleeding gastric ulcer, occult blood test ≥ (++), and vasculitis.
  • Planned systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, within 4 weeks prior to enrollment in other anti-cancer drug clinical trials or within 4 weeks prior to grouping or during the study.
  • Physical examination and laboratory inspection:
  • Have a positive history of human immunodeficiency virus (HIV) test or have acquired immunodeficiency syndrome (AIDS).
  • Untreated active hepatitis (Hepatitis B: HBsAg-positive and HBV DNA ≥ 500IU/mL; Hepatitis C: HCV RNA-positive and abnormal liver function); Combined hepatitis B and C infection
  • At the discretion of the investigator, the patient may have other factors that may cause the study to be terminated midway, such as other serious illnesses or serious laboratory abnormalities or other safety that may affect the subject, or test data and samples. Factors such as family or society collected.

Trial locations and contacts

1 site in 1 country.

Dehua Wu contact

020-61642136

331576705@qq.com

China1 site, 1 recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

    Dehua Wu, 020-62787693, 18602062748@163.com

    Recruiting

Other trials in China

About this study

Official title: An Open, Single-arm, Multi-center Exploratory Study of Sequential Anlotinib Followed by EP Regimen Plus Concurrent Radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to evaluate the efficacy and safety of sequential anlotinib followed by EP regimen plus concurrent radiotherapy for unresectable stage III non-small cell lung cancer(NSCLC).

Being tested
Anlotinib Hydrochloride
Keywords
anlotinib

What participants receive

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

  • Anlotinib HydrochlorideDrug

    anlotinib once daily on days 1-14 of 21days cycle.

Study groups in NCT04111913
Study groupRoleWhat they receive
anlotinib and chemoradiotherapyExperimentalanlotinib: 12 mg, po, qd, on day1-14 of a 21 days cycle; anlotinib will be administrated to 2 cycles for induction before the 2 cycles of chemoradiation and anlotinib will be administrated up to 1year or disease progression for maintenance treatment. EP regimen: cisplatin 50mg/m2, d1, 8, 29, 36; etoposide 50mg/m2, d1~5, d29~33. Radiotherapy program: 2 Gy / time / d, 5 d / week;PTV radiotherapy 60~66Gy/30~33 times/6~7 weeks.
Receives: Drug: Anlotinib Hydrochloride

What is being measured

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

  1. Progress-free survival (PFS)

    Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

    Measured: Approximately 12 months.

Secondary outcomes (4)

  1. The recurrence rate in 12-month

    The proportion of patients with disease progression within 12 months of the initiation of consolidation treatment with anlotinib.

    Measured: 12 months.

  2. The recurrence rate in 24-month

    The proportion of patients with disease progression within 24 months of the initiation of consolidation treatment with anlotinib.

    Measured: 12 months.

  3. The disease control rate in 6-month

    The proportion of CR, PR, and SD within 6 months of the initiation of consolidation treatment with anlotinib.

    Measured: 6 months.

  4. The disease control rate in 12-month

    The proportion of CR, PR, and SD within 12 months of the initiation of consolidation treatment with anlotinib.

    Measured: 12 months.

Timeline

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

  1. First posted1 Oct 2019
  2. Study start1 Oct 2019 (estimated)
  3. Primary completion31 Aug 2020 (estimated)
  4. Study completion31 Aug 2022 (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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04111913
Sponsor's protocol ID
ALTER-L028
Status last verified
Aug 2019
First submitted
25 Sep 2019
Last updated
1 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib Hydrochloride in people with Unresectable Stage III Non-small Cell Lung Cancer, run by Nanfang Hospital, Southern Medical University 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 14 inclusion and 24 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 1 Oct 2019. 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 Dehua Wu (020-61642136, 331576705@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress-free survival (PFS) (time frame: Approximately 12 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 NCT04111913.

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 1 Oct 2019.

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