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

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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

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date August 17, 2018
Estimated Study Start Date  ICMJE August 15, 2018
Estimated Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • Objective Response Rate (ORR) [ Time Frame: each 21 days up to the toxicity or PD (up to 24 months) ]
    Objective Response Rate
  • Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
    Disease Control Rate
  • Overall Survival (OS) [ Time Frame: From enrollment until death (up to 36 months) ]
    Overall survival
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NSCLC
  • Adenocarcinoma
  • Squamous Cell Carcinoma
Intervention  ICMJE
  • 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 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 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
  • 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
Study Arms  ICMJE
  • Experimental: Non-squamous cell lung cancer

    Anlotinib combined with pemetrexed and carboplatin, phase I

    Anlotinib combined with pemetrexed and carboplatin, phase II

    Interventions:
    • Drug: Anlotinib combined with pemetrexed and carboplatin, phase I
    • Drug: Anlotinib combined with pemetrexed and carboplatin, phase II
  • Experimental: Squamous cell lung cancer

    Anlotinib combined with paclitaxel and carboplatin, phase I

    Anlotinib combined with paclitaxel and carboplatin, phase II

    Interventions:
    • Drug: Anlotinib combined with paclitaxel and carboplatin, phase I
    • Drug: Anlotinib combined with paclitaxel and carboplatin, phase II
Publications * Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 16, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 14, 2020
Estimated Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03636685
Other Study ID Numbers  ICMJE NCC201807006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shi Yuankai, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese Academy of Medical Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP