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Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer(ALTER-L029) (ALTER-L029)

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ClinicalTrials.gov Identifier: NCT03743129
Recruitment Status : Not yet recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Anhui Shi, MD, Beijing Cancer Hospital

November 11, 2018
November 15, 2018
November 15, 2018
November 30, 2018
November 30, 2020   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Estimated to be from baseline up to 3 years ]
the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Same as current
No Changes Posted
  • Disease Control Rate at 6 months(DCR6) [ Time Frame: Estimated to be from baseline up to 3 years ]
    the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 6 months after randomization
  • Disease Control Rate at 12 months(DCR12) [ Time Frame: Estimated to be from baseline up to 3 years ]
    the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 12 months after randomization
  • Overall Survival at 12 months (OS12) [ Time Frame: Estimated to be from baseline up to 3 years ]
    the percentage of patients who are alive at 12 months after randomization per the Kaplan-Meier estimate of overall survival at 12 months
  • Overall Survival at 24 months (OS24) [ Time Frame: Estimated to be from baseline up to 3 years ]
    the percentage of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months
  • Recurrence rate at 12 months [ Time Frame: Estimated to be from baseline up to 3 years ]
    the percentage of patients with Progressive Disease(PD) at 12 months after randomization
  • Recurrence rate at 24 months [ Time Frame: Estimated to be from baseline up to 3 years ]
    the percentage of patients with Progressive Disease(PD) at 24 months after randomization
Same as current
Not Provided
Not Provided
 
Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer(ALTER-L029)
A Randomised, Open, Blank-controlled, Multi-centre Study of Anlotinib as Sequential Therapy in Patients With Unresectable NSCLC(Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy
Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer
Anlotinib (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 VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer Stage III
Drug: Anlotinib
Anlotinib 12mg p.o, qd
Other Name: AL3818
  • Experimental: Anlotinib
    Anlotinib p.o, qd. Treatment from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) to disease progress or untolerated toxicity or consent withdrawal. The 2:1 ratio (Anlotinib to blank).
    Intervention: Drug: Anlotinib
  • No Intervention: Blank
    No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
Same as current
November 30, 2021
November 30, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1.Age at least 18 years.
  • 2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III).
  • 3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
  • 4.ECOG PS : 0 to 1.
  • 5.Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

  • 1.Prior exposure to any anti-angiogenesis drugs.
  • 2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis.
  • 3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  • 4.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
  • 5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Not Provided
 
 
NCT03743129
2018YJZ47
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Anhui Shi, MD, Beijing Cancer Hospital
Anhui Shi, MD
Not Provided
Not Provided
Beijing Cancer Hospital
November 2018

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