First-line Combination Treatment Based on Anlotinib

Last updated: August 9, 2018
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Non-small Cell Lung Cancer

Cancer

Lung Disease

Treatment

N/A

Clinical Study ID

NCT03628521
ACTION
  • Ages 18-75
  • All Genders

Study Summary

The aim of this study is to explore safety and therapeutic efficacy of anlotinib combined with erlotinib/chemotherapy/IBI308 as first-line treatment in advanced NSCLC patients. The primary endpoints of the study are safety and objective response rate (ORR);the secondary endpoints are disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients have voluntarily to join the study and give written informed consent for thestudy

  2. Histologically documented, unresectable, inoperable, locally advanced, recurrent ormetastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)

  3. A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)

  4. Mutation status including EGFR, ALK ROS are explicit;

  5. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria inSolid Tumours (RECIST) criteria.

  6. Patients did not receive systemic anti-cancer therapy previously, includingtraditional Chinese medicine.

  7. Able to comply with study and follow-up procedures

  8. Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3months;enough organ function;

8)Major organ function

  1. For regular test results(no blood transfusion within 14 days):

  2. Hemoglobin(HB)≥90g/L;

  3. Absolute neutrophils count(ANC)≥1.5×109/L;

  4. Blood platelets(PLT)≥80×109/L

  5. Biochemical tests results defined as follows:

  6. Total bilirubin(TBIL)≤1.5 times the upper limit of normal (ULN) ;

  7. Alanine aminotransferase(ALT)and aspartate aminotransgerase AST≤2.5ULN,livermetastases,if any,ALT和AST≤5ULN;

  8. Creatinine(Cr)≤1.5ULN or Creatinine Clearance rate (CCr)≥60 ml/min;

  9. Doppler ultrasound assessment:left ventricular ejection fraction (LVEF) ≥the lowerlimit of normal value(50%).

Exclusion

Exclusion Criteria:

  1. Small cell lung cancer(including patients with mixed small cell lung cancer andnon-small cell lung cancer) or central squamous cell carcinoma with cavity

  2. Mutation status are unknown

  3. Previously (within 5 years) or presently suffering from other malignancies,

  4. Symptomatic or uncontrolled brain metastases

  5. Unstable systemic disease, including active infection, uncontrolled hypertension,unstable angina, congestive heart failure, or myocardial infarction within 6 months orserious cardiac arrhythmia requiring medication

  6. History of other diseases, metabolic dysfunction, physical examination finding, orclinical laboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug or that might affect theinterpretation of the results of the study or render the patient at high risk fromtreatment complications

  7. Gastrointestinal tract disease resulting in an inability to take oral medication or arequirement for intravenous (IV) alimentation, or prior surgical procedures affectingabsorption

  8. Pregnancy or lactation

  9. Previously treated including treated with traditional Chinese medicine

  10. Patients who are allergic to any of the agent or any ingredient -

Study Design

Total Participants: 80
Study Start date:
July 20, 2018
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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