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Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03636685
Recruitment Status : Unknown
Verified August 2018 by Shi Yuankai, Chinese Academy of Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Shi Yuankai, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
Non-small cell lung cancer has the highest morbidity and mortality in China，and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.

Condition or disease Intervention/treatment Phase
NSCLC Adenocarcinoma Squamous Cell Carcinoma Drug: Anlotinib combined with pemetrexed and carboplatin, phase I Drug: Anlotinib combined with paclitaxel and carboplatin, phase I Drug: Anlotinib combined with pemetrexed and carboplatin, phase II Drug: Anlotinib combined with paclitaxel and carboplatin, phase II Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Anlotinib Combined With Platinum-based Chemotherapy as the First-line Treatment of Patients With Locally Advanced or Advanced Non-Small Cell Lung Cancer
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : August 14, 2019
Estimated Study Completion Date : August 14, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-squamous cell lung cancer

Anlotinib combined with pemetrexed and carboplatin, phase I

Anlotinib combined with pemetrexed and carboplatin, phase II

 Drug: Anlotinib combined with pemetrexed and carboplatin, phase I

Non-squamous cell lung cancer, Anlotinib Plus PC

This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus pemetrexed and carboplatin. middle-dose groups: Anlotinib 10mg per day plus pemetrexed and carboplatin. high-dose groups: Anlotinib 12mg per day plus pemetrexed and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin

Other Name: APC I

Drug: Anlotinib combined with pemetrexed and carboplatin, phase II
Anlotinib: established dose QD PO d1-14, pemetrexed,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Other Name: APCII
Experimental: Squamous cell lung cancer

Anlotinib combined with paclitaxel and carboplatin, phase I

Anlotinib combined with paclitaxel and carboplatin, phase II

 Drug: Anlotinib combined with paclitaxel and carboplatin, phase I

Squamous cell lung cancer, Anlotinib plus TC

This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus paclitaxel and carboplatin. middle-dose groups: Anlotinib 10mg per day plus paclitaxel and carboplatin. high-dose groups: Anlotinib 12mg per day plus paclitaxel and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin

Other Name: ATC I

Drug: Anlotinib combined with paclitaxel and carboplatin, phase II

Anlotinib :established dose QD PO d1-14, paclitaxel,carboplatin, 21 days per cycle

after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent

Other Name: ATCII


Outcome Measures
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Primary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months ]
    progression free survival


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: each 21 days up to the toxicity or PD (up to 24 months) ]
    Objective Response Rate

  2. Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
    Disease Control Rate

  3. Overall Survival (OS) [ Time Frame: From enrollment until death (up to 36 months) ]
    Overall survival

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety) [ Time Frame: Time Frame: each 21 days up to the toxicity or PD (up to 36 months) ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age：18~70 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
  • Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
  • EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
  • No indications for radiation therapy
  • Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year
  • Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI

Exclusion Criteria:

  • Small Cell Lung Cancer
  • central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
  • Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
  • Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
  • have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  • Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start)
  • with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
  • Previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia
  • get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism
  • Have suffered from hemorrhagic disease or coagulation dysfunction
  • diagnosed with disease which will severely endanger the security of patients or influence the completion of this research
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636685


Contacts
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Contact: Yuankai Shi, MD +86 13701251865 syuankaipumc@126.com
Contact: Zhaoyuan Shi +8615801570739 szy957@aliyun.com

Sponsors and Collaborators
Chinese Academy of Medical Sciences
More Information
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Publications of Results:

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Responsible Party: Shi Yuankai, Vice President of Cancer Hospital Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03636685    
Other Study ID Numbers: NCC201807006
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shi Yuankai, Chinese Academy of Medical Sciences:
Anlotinib
NSCLC
platinum-based chemotherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors