A Phase Ib, Open-label, Single Center, Non-randomized Study for Safety and Efficacy of TQB2450 Combined With Anlotinib in Subjects With Advanced Mutation Positive Non-Small Cell Lung Cancer

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country30 target enrollmentJune 3, 2019

ConditionsLung Cancer

InterventionsTQB2450 Anlotinib

DrugsTQB2450 Anlotinib

Overview

Phase: Phase 1
Intervention: TQB2450
Conditions: Lung Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: Overall response rate （ORR）
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single center, non-randomized, phase Ib trial to evaluate safety and efficacy of TQB2450 injection combined with anlotinib in patients with advanced mutation positive non-small cell lung cancer.

Registry

clinicaltrials.gov

Start Date

June 3, 2019

End Date

December 31, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understood and signed an informed consent form.
•18 years and older.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
•Histologically or cytologically confirmed mutation positive non-small cell lung cancer according to 8th International Association for the Study of Lung Cancer (IASLC) edition.
•Has measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
•Adequate organ system function, defined as follows:
•absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, platelets (PLT) ≥ 100×10\^9/L, hemoglobin (Hb)≥ 90g /L;
•total bilirubin (TBIL) ≤ 1.5×ULN；alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN (without liver metastasis) or ≤ 5.0 × ULN (with liver metastasis), Creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 ml/min;
•Urine protein \< ++，or urine protein ≥ ++ concomitant with content of 24-hour urinary protein \<1.0 g;
•international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤ 1.5×ULN;

Exclusion Criteria

•Has diagnosed and/or treated additional malignancy within 5 years prior to randomization except of cured in situ carcinoma of the cervix, non-melanoma skin cancer and superficial bladder carcinoma.
•Has severe hypersensitivity reactions after taking other monoclonal antibodies.
•Has hypersensitivity reactions after taking anlotinib.
•Has prior therapy with anlotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or other immunotherapy against PD-1/PD-L
•Has any active autoimmune disease or history of autoimmune disease, such as autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis, asthma patients who need bronchiectasis for medical intervention; Subjects with the vitiligo without systemic treatment, psoriasis, alopecia, well-controlled type I diabetes mellitus, hypothyroidism stable on hormone replacement will not be excluded from this study.
•Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
•Has clinical significance of thyroid dysfunctions within 6 months prior to enrollment, and even though medical therapy, thyroid function can not return to normal or no clinical significance.
•Has central nervous system (CNS) metastases without local therapy of lesion.
•Radiograph (within 28 days before enrollment) showed that the tumor surrounded important blood vessels, and the investigators determined that entering the study would cause bleeding risk.
•Hemoptysis (defined as coughing out or spitting out ≥ 1 teaspoon of blood or small blood clots or hemoptysis without sputum) within 28 days before enrollment , not including bloody sputum.

Arms & Interventions

TQB2450 Combined with Anlotinib

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg 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)

Intervention: TQB2450