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Carcinoma, Non-Small-Cell LungPhase 2NCT03672136

Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients

A Phase 2 study testing Anlotinib and Concurrent Chemoradiotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Shandong Cancer Hospital and Institute 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Anlotinib and Concurrent Chemoradiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Nov 2018to 1 Nov 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

  • Patients voluntarily participate in this study, signed informed consent.
  • Patients pathologically diagnosed as locally advanced (IIIB / IV) unresectable non-small cell lung cancer, with measurable lesions; IIIa3 patient: Multiple stations lymph node metastasis detected by mediastinoscope, other lymph node biopsy or PET-CT; IIIa4 patient: Bulky or stable multiple stations N2 lymph node metastasis (Bulky lymph node: short diameter > 2cm in spiral CT imaging, especially the extranodal invasion); and IIIb patient; T3/4 patient with several ipsilateral or contralateral satellite nodules metastasis will be excluded.
  • Detection of genotypes by providing detectable specimens (tissue) prior to enrollment: patients with negative EGFR mutation, or ALK rearrangement test results.
  • Patients aged between 18 -75 years; with ECOG PS Scoring: 0~1 point; with expected survival time>3 months.
  • Patients with normal organ function within 7 days prior to treatment, the following criteria are met:
  • blood routine examination criteria (without blood transfusion in 14 days) : i) hemoglobin (HB) ≥100g/L; ii) white blood cell (WBC)≥ 3.0×10e9/L, absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥100×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;
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  • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50% lower limit of normal (LLN);
  • Lung function evaluation: forced expiratory volume in first second (FEVI)≥1.45L/s.
  • Exclusion Criteria(Patient meet any criteria as following will be excluded):
  • Patients who had previously used anlotinib hydrochloride capsules;
  • Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
  • Patients with empty lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (>20 mL/day);
  • Patients had other malignancies in the past 5 years or currently, except undergone resection and at least 5 years of progression free survival or cured cervical cancer in situ, basal cell carcinoma and superficial bladder tumor;
  • Patients who planned to receive systemic anti-tumor therapy within 4 weeks prior to allocation or during the course of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, except the immunoregulation agents, such as thymosin and lentinan;
  • Patients with more than common terminology criteria for adverse events (CTC AE) level 1 unmitigated toxicity due to any previous treatment, not including hair loss;
  • Patients have a variety of factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.);
  • Patients with pleural effusion or ascites, causing respiratory syndrome (≥ CTC AE level 2 dyspnea);
  • Patients with any severe and/or uncontrolled disease, including:
  • blood pressure control is not ideal (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
  • myocardial ischemic or myocardial infarction, arrhythmia (including QTc ≥480 ms) and ≥ 2 levels of congestive heart failure (NYHA classification);
  • active or uncontrollable serious infection (≥CTC AE Level 2 infection);
  • liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need to be treated with antiretroviral therapy;
  • renal failure requires hemodialysis or peritoneal dialysis;
  • history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation;
  • poor control of diabetes (fasting blood glucose [FBG]> 10 mmol/L);
  • urine routine test protein≥++, and confirmed 24 hours urine protein>1.0 g;
  • patients with a seizure and need treatment;
  • Patients with gastric ulcer;
  • Received a major surgical treatment within 28 days prior to allocation, with a biopsy or a significant traumatic injury;
  • Imaging shows that the tumor has been violated around important vascular or the researchers determine the tumor is likely to invade important blood vessels caused by fatal bleeding during the follow-up;
  • Regardless of the severity, patients with any signs or medical history of bleeding; within 4 weeks prior to allocation, patients with any bleeding events ≥ CTC AE level 3, unhealed wounds, ulcers or fractures;
  • Patients with artery/venous thrombotic occurred within 6 months before allocation, such as cerebrovascular accident (including temporary ischemic attack),deep vein thrombosis and pulmonary embolism;
  • Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
  • Patients during pregnancy or lactation period;
  • Patients participated in other anti-tumor drug clinical trials within 4 weeks;
  • According to the determination of researchers, patients were diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Ming Huan Li, doctor contact

131 5303 5389

sy_lmh2001@163.com

JINMING YU, doctor contact

13806406293 ext. 0531-87984729

jn7984729@public.jn.sd.cn

China1 site

  • SHANDONG Cancer Hospital and Institute

    Jinan, Shandong, 250000

    MINGHUAN LI, Doctor, 13153035389 ext. 0531-67626112, Sy_lmh2001@163.com

    JIMING YU, Doctor, 13806406293 ext. 0531-87984729, jn7984729@public.jn.sd.cn

Other trials in China

About this study

Official title: Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients：An Exploratory Single-Arm Phase II Clinical Trail

The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients.

Read the detailed description

The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients, whether this regimen can improve PFS.

Being tested
Anlotinib, Concurrent Chemoradiotherapy
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.

  • AnlotinibDrug

    Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.

  • Concurrent ChemoradiotherapyOther

    Concurrent chemoradiotherapy as the current standard of care for unresectable stage III non small cell lung cancer patients

Study groups in NCT03672136
Study groupRoleWhat they receive
Concurrent Chemoradiotherapy+AnlotinibExperimental1. Radiotherapy: Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60～66Gy. If radiotherapy and chemotherapy are conducted in the same day, chemotherapy should be priority to radiotherapy. 2. Chemotherapy: Platinum based dual drug regime determined by researcher.After finishing concurrent chemoradiotherapy, there is no need of maintenance chemotherapy. 3. Anlotinib: Combined with 12mg/d QD Anlotinib on the first, second weeks and fourth, fifth weeks of radiotherapy, that is on the day1~14, day22~36. 4. Maintenance therapy: One month after finishing concurrent chemoradiotherapy, 12mg/d QD Anlotinib can be administrated, each cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment. The treatment can continue until disease progression or treatment intolerance, but should not exceed 24 months. 5. During the course of study, it's not allowed to receive other anti-tumor therapy.
Receives: Drug: Anlotinib; Other: Concurrent Chemoradiotherapy

What is being measured

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

  1. PFS

    Progression Free Survival

    Measured: 2 years

Secondary outcomes (3)

  1. OS

    Overall survival

    Measured: 2 years

  2. ORR

    Objective Response Rate

    Measured: 2 years

  3. DCR

    Disease Control Rate

    Measured: 2 years

Timeline

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

  1. First posted14 Sep 2018
  2. Study start1 Nov 2018 (estimated)
  3. Primary completion1 Nov 2019 (estimated)
  4. Study completion1 Nov 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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672136
Sponsor's protocol ID
ALTER0300
Status last verified
Sep 2018
First submitted
13 Sep 2018
Last updated
14 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pritchard RS, Anthony SP. Chemotherapy plus radiotherapy compared with radiotherapy alone in the treatment of locally advanced, unresectable, non-small-cell lung cancer. A meta-analysis. Ann Intern Med. 1996 Nov 1;125(9):723-9. doi: 10.7326/0003-4819-125-9-199611010-00003.

    PubMed 8929005

  • Bao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9.

    PubMed 25497558

  • Han B, Li K, Wang Q, Zhang L, Shi J, Wang Z, Cheng Y, He J, Shi Y, Zhao Y, Yu H, Zhao Y, Chen W, Luo Y, Wu L, Wang X, Pirker R, Nan K, Jin F, Dong J, Li B, Sun Y. Effect of Anlotinib as a Third-Line or Further Treatment on Overall Survival of Patients With Advanced Non-Small Cell Lung Cancer: The ALTER 0303 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):1569-1575. doi: 10.1001/jamaoncol.2018.3039.

    PubMed 30098152

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib and Concurrent Chemoradiotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Shandong Cancer Hospital and Institute 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 36 inclusion and 0 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 14 Sep 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 Ming Huan Li, doctor (131 5303 5389, sy_lmh2001@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: 2 years). 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 NCT03672136, which also lists 3 linked publications.

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 14 Sep 2018.

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