A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus K Drug in the Treatment of First-line Non-small Cell Lung Cancer(NSCLC)

NCT04964479 | Unknown Phase 3

• 1 other identifier: TQB2450-III-09
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 17

Brief Summary

A clinical study to evaluate the efficacy and safety of TQB2450 injection combined with Anlotinib Hydrochloride capsules versus K drug as a first-line treatment of advanced non-small cell lung cancer.A total of 375 subjects will be enrolled.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease progression-free survival(PFS) evaluated by Independent Review Committee (IRC)

  The period from the first use of the drug to disease progression or death (whichever occurs first)

  Baseline to up to two years

Secondary Outcomes (8)

• Overall survival (OS)

  Baseline to up to two years

• Disease PFS evaluated by investigators

  Baseline to up to two years

• Objective response rate (ORR) evaluated by investigators

  Baseline to up to two years

• Disease Control Rate (DCR)

  Baseline to up to two years

• Duration of response (DOR)

  Baseline to up to two years

Study Arms (2)

TQB2450 injection + Anlotinib Hydrochloride capsules

EXPERIMENTAL

TQB2450 injection: once every 3 weeks, 1200mg each time, intravenous infusion. Until the disease progression or unbearable adverse events occur. Anlotinib Hydrochloride capsules: once a day,12mg each time, oral administration before breakfast. Continuous administration for 2 weeks, withdrawal for 1 week, i.e. 3 weeks (21 days) as a course of treatment. Until the disease progression or unbearable adverse events occur.

Drug: TQB2450 injection; Drug: Anlotinib Hydrochloride Capsules

Pembrolizuma injection + placebo of Anlotinib hydrochloride capsules

ACTIVE COMPARATOR

Pembrolizumab injection: once every 3 weeks, 200mg each time, intravenous infusion. Until the disease progression or unbearable adverse events occur. Placebo of Anlotinib hydrochloride capsules:once a day, 0mg each time, oral administration before breakfast. Continuous administration for 2 weeks, withdrawal for 1 week, i.e. 3 weeks (21 days) as a course of treatment. Until the disease progression or unbearable adverse events occur.

Drug: Pembrolizumab injection; Drug: Placebo

Interventions

TQB2450 injection DRUG

1200mg injection once every 3 week

TQB2450 injection + Anlotinib Hydrochloride capsules

Anlotinib Hydrochloride Capsules DRUG

12mg capsule once daily

TQB2450 injection + Anlotinib Hydrochloride capsules

Pembrolizumab injection DRUG

200mg injection once every 3 week

Pembrolizuma injection + placebo of Anlotinib hydrochloride capsules

Placebo DRUG

Placebo capsule once daily

Pembrolizuma injection + placebo of Anlotinib hydrochloride capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the 8th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, the tumor node metastasis (TNM) staging of lung cancer is locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) NSCLC patients. (Note: Mixed tumors will be classified according to the main cell type; if there are small cell components, the subject is unqualified).
• Between the ages of 18-75 years (calculated based on the date of signing ICF); male or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥ 3 months.
• According to the RECIST 1.1 standard, there is at least one measurable lesion. If the measurable lesion is located in the radiotherapy area, it should be clearly defined as a progressive state.
• Patients who have not received systemic anti-tumor therapy for advanced, recurrent or metastatic diseases in the past. For those who have received adjuvant chemotherapy in the past, the interval between the recurrence time and the last adjuvant chemotherapy should be at least 6 months; The interval between the end of previous radiotherapy for chest and this treatment should be more than 6 months, and the interval between palliative radiotherapy for chest and this treatment should be more than 7 days.
• Tumor tissue slices that have not undergone radiotherapy at or after the diagnosis of advanced or metastatic NSCLC must be provided. Tumor tissue samples must be archived samples or fresh samples obtained within 12 months before randomization, and the proportion of programmed death-Ligand 1(PD-L1) positive tumor cells≥ 1% (TPS ≥ 1%).
• For non-squamous NSCLC, patients with no epidermal growth factor receptor (EGFR) mutations and ALK fusions (for squamous NSCLC, patients with known EGFR mutations and anaplastic Lymphoma kinase (ALK) fusions need to be excluded, and those with unknown status are not mandatory to be tested).
• The function of main organs are well and meet the following standards:
• a. Routine blood examination standards (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): i. Absolute neutrophil count (ANC) ≥1.5×109 /L; ii. Platelets ≥100×109 /L; iii. Hemoglobin ≥90 g/L. b. The blood biochemical examination shall meet the following standards: i. Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (Patients with Gilbert syndrome ≤ 3 × ULN); ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN. If it is accompanied by liver metastasis, ALT and AST≤5×ULN; iii. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance estimated by Cockcroft-Gault glomerular filtration formula ≥60 mL/min; iv. Serum albumin (ALB) ≥30g/L. c. Urine routine examination standard: urine routine indicates urine protein \<++; if urine protein ≥++, it is necessary to confirm that the 24-hour urine protein quantitative ≤1.0 g.
• d. Blood coagulation test standards: prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR)≤1.5×ULN (no anticoagulant therapy).
• e. Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, it can be selected.
• f. Heart color Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%.
• g. 12-lead ECG evaluation: QTc\<450ms (male), QTc\<470ms (female).
• Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum pregnancy test within 7 days before the study enrollment; men should agree to the study period and 6 months after the end of the study period Effective contraceptive measures must be used internally.
• The subjects voluntarily joined the study, signed the informed consent form, and had good compliance.

You may not qualify if:

• Tumor disease and medical history:
• Brain metastases without local treatment; Note: Subjects who have previously received brain metastasis therapy and meet all the following criteria can participate in this study: i. Only supratentorial and cerebellar metastases; ii. The condition needs to be stable for ≥4 weeks and no new brain metastases or brain metastases are found Expanded imaging evidence; iii. The subject must have stopped corticosteroids/dehydrator for at least 2 weeks before starting to use the trial drug;
• There are midbrain, pons, medulla oblongata, spinal cord and meningeal metastases；
• Other malignant tumors appeared or were present within 3 years. The following two cases can be included: other malignant tumors treated by single operation have achieved 5-year Disease-free survival (DFS) in a row; The cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• Central type, cavity squamous cell carcinoma (primarily in the main bronchus and around the hilar);
• Imaging shows that the tumor invades large blood vessels or is unclearly separated from the blood vessels, or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the subsequent study(The major vessels in the chest include pulmonary aorta, left pulmonary artery, right pulmonary artery, four pulmonary veins, superior vena cava, inferior vena cava and aorta);
• Severe bone injury caused by tumor bone metastasis, including pathological fracture of weight-bearing bone and spinal cord compression that occurred within 6 months or is expected to occur in the near future(Such as spine, pelvis, femur, tibia, phalanges, calcaneus, etc.);
• Patients with serous cavity (thoracic cavity, abdominal cavity, or pericardial cavity) that require repeated drainage to relieve clinical symptoms (as determined by the investigator), or who have received drainage of serous cavity effusion for the purpose of treatment within 2 weeks before treatment.
• Previous anti-tumor treatments:
• Received the treatment of proprietary Chinese medicines with anti-tumor indications specified in the NMPA approved drug instructions within 2 weeks before the start of the study treatment(Including compound cantharidin capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule, etc.);
• Previously received related immunotherapy drugs for programmed death 1 (PD-1), PD-L1, cytolytic T lymphocyte-associated antigen-4 (CTLA-4), etc.;
• Previous use of anti-angiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib, etc.;
• Patients who have been vaccinated with immunomodulatory drugs within 30 days before starting treatment(Such as interleukin-2, thymosin, lentinan, etc.);
• Failure to recover from the toxicity and/or complications of previous interventions to CTCAE ≤1, except for hair loss and peripheral neuropathy ≤2;
• Combined diseases and medical history:

Sponsors & Collaborators

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

Study Sites (17)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Affiliated Hospital of Guangdong Medical University

Zhangjiang, Guangdong, 524000, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

The Ninth Affiliated People's Hospital of Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 201900, China

NOT YET RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Affiliated Tumor Hospital of Chongqing University

Chongqing, China

NOT YET RECRUITING

Three Gorges Hospital of Chongqing University

Chongqing, China

NOT YET RECRUITING

Southern Hospital of Southern Medical University

Guangzhou, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

NOT YET RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, China

NOT YET RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, China

NOT YET RECRUITING

The Fifth Central Hospital of Tianjin

Tianjin, China

NOT YET RECRUITING

Related Publications (1)

• Zhang W, Wang J, Wang Q, Cheng Y, Yang L, Li Y, Zhong H, Chu T, Dong Y, Zhang Y, Qian F, Xiong L, Shi C, Zhang C, He Z, Zhu J, Liu X, Ma H, Li K, Han B. A randomized double-blind trial of TQB2450 with or without anlotinib in pretreated driver-negative non-small cell lung cancer. Lung Cancer. 2023 Oct;184:107353. doi: 10.1016/j.lungcan.2023.107353. Epub 2023 Aug 21.

  PMID: 37647728 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Baohui Han, Doctor

CONTACT

18930858216; 18930858216@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 16, 2021
• Study Start: August 6, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: August 20, 2021

Record last verified: 2021-07

Locations

CN (17)