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Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04073537
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.

Condition or disease Intervention/treatment Phase
Squamous Non-small Cell Lung Cancer Drug: Anlotinib Drug: Placebos Drug: Paclitaxel Drug: Carboplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Experimental group
Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
Drug: Anlotinib
A multi-target receptor tyrosine kinase inhibitor.

Drug: Paclitaxel
Paclitaxel 175 mg/m^2 IV on Day 1 of each 21-day cycle.

Drug: Carboplatin
Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.

Placebo Comparator: Placebo group
Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
Drug: Placebos
Anlotinib blank analog capsule.

Drug: Paclitaxel
Paclitaxel 175 mg/m^2 IV on Day 1 of each 21-day cycle.

Drug: Carboplatin
Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) evaluated by IRC [ Time Frame: up to 24 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) evaluated by investigator [ Time Frame: up to 24 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

  2. Overall Survival (OS) [ Time Frame: up to 24 months ]
    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

  3. Overall Response Rate (ORR) [ Time Frame: up to 24 months ]
    Percentage of participants achieving complete response (CR) and partial response (PR).

  4. Disease Control Rate(DCR) [ Time Frame: up to 24 months ]
    Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

  5. Duration of Overall Response (DOR) [ Time Frame: up to 24 months ]
    The time when the patient first achieved complete or partial remission to disease progression.

  6. PFS rate at month 6 [ Time Frame: up to 6 months ]
    The percentage of PFS at month 6.

  7. PFS rate at month 12 [ Time Frame: up to 12 months ]
    The percentage of PFS at month 12.

  8. OS rate at month 6 [ Time Frame: up to 6 months ]
    The percentage of OS at month 6.

  9. OS rate at month 12 [ Time Frame: up to 12 months ]
    The percentage of OS at month 12.

  10. OS rate at month 18 [ Time Frame: up to 18 months ]
    The percentage of OS at month 18.

  11. Adverse Event (AE) [ Time Frame: up to 24 months ]
    Safety data

  12. Serious Adverse Event (SAE) [ Time Frame: up to 24 months ]
    Safety data

  13. Abnormal laboratory test index [ Time Frame: up to 24 months ]
    Safety data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Squamous non-small cell lung cancer.
  2. A measurable lesion.
  3. The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.

Exclusion Criteria:

  1. The tumor invades the large blood vessels.
  2. Central type squamous non-small cell lung cancer.
  3. EGFR/ALK gene mutation is positive.
  4. Has used EGFR inhibitors and ALK inhibitors.
  5. Has other malignant tumors within 5 years.
  6. Has a variety of factors affecting oral medications.
  7. Symptomatic brain metastasis.
  8. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
  9. Spinal cord compression.
  10. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
  11. Severe allergies to therapeutic medications.
  12. Adverse events caused by previous treatment did not recover to grade 1.
  13. Has received major surgical treatment within 4 weeks before randomization.
  14. Arteriovenous thrombosis occurred within 6 months.
  15. Has drug abuse history that unable to abstain from or mental disorders.
  16. Has severe or uncontrolled disease.
  17. Participated in other clinical trials within 4 weeks.
  18. According to the investigators' judgement.

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): NCT04073537


Contacts
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Contact: Yuankai Shi, Doctor 010-87788293 syuankaipumc@126.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100083
Contact: Yuankai Shi, Doctor    010-87788293    syuankaipumc@126.com   
Principal Investigator: Yuankai Shi         
China, Hebei
The Fourth Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 50011
Contact: Cuimin Ding, Master    0311-86095341    wjwdcm@sina.com   
Principal Investigator: Cuimin Ding, Master         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04073537     History of Changes
Other Study ID Numbers: ALTN-03-III-02
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action