Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC

NCT04116918 | Unknown DMC

• 1 other identifier: AJERTNN
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.

Conditions

NSCLC Stage IV; EGFR T790M-negative; Anlotinib; JS001

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  Time from treatment beginning until disease progression

  Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months

• Objective Response Rate

  Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.

  Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months

Secondary Outcomes (2)

• Overall Survival

  From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months

• Adverse Effect

  Through study completion, an average of 1 months

Eligibility Criteria

• Age: 18 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

EGFR-TKI Resistant T790M-Negative NSCLC

You may qualify if:

• Adult patients \>=18 years of age
• Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation
• EGFR-TKI resistent
• EGFR T790M negative
• Expected survival ≥ 3 month;
• ECOG / PS score: 0-2;
• the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

You may not qualify if:

• EGFR-T790M positive
• with druggable gene alteration;
• Patient can not comply with research program requirements or follow-up;

Sponsors & Collaborators

• Baodong Qin: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Resident

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: October 7, 2019
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

CN (1)