Study of TQB2450 Combined With Anlotinib in the Treatment of Mutation Positive Lung Cancer

NCT03983928 | Unknown Phase 1

• 1 other identifier: TQB2450-Ib-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate （ORR）

  Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)

  up to approximately 12 months

Secondary Outcomes (3)

• Progression-free survival (PFS)

  up to approximately 12 months

• Overall survival (OS)

  up to approximately 15 months

• Disease control rate（DCR）

  up to approximately 12 months

Study Arms (1)

TQB2450 Combined with Anlotinib

EXPERIMENTAL

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)

Drug: TQB2450; Drug: Anlotinib

Interventions

TQB2450 DRUG

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

TQB2450 Combined with Anlotinib

Anlotinib DRUG

a multi-target receptor tyrosine kinase inhibitor

TQB2450 Combined with Anlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understood and signed an informed consent form.
• 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 1.1.
• 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;
• left ventricular ejection fraction (LVEF) ≥ 50%;
• Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

You may not qualify if:

• 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-L1.
• 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.
• Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage \> 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
• Has any of the following severe acute complications:
• Unstable angina and/or congestive heart failure or vascular disease requiring hospitalization within 12 months, or other cardiac impairments determined by the investigator, which may affect the evaluation of drug safety; Myocardial infarction or ischemia with ST elevation ≥ 2 mm indicated by electrocardiogram (ECG);
• Has pulmonary infections and/or acute bacterial or fungal infections requiring intravenous antibiotic therapy;
• Has clinical jaundice caused by liver dysfunction;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Li Zhang

CONTACT

020-87343458; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: June 3, 2019
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

CN (1)