Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

NCT06141226 | Recruiting Phase 2

• 1 other identifier: TQB2450-ALTN-II-02
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 5

Brief Summary

Objective to compare the efficacy and safety of TQB2450 injection combined with anlotinib and chemotherapy, and TQB2450 injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer subjects who failed to receive first-line chemotherapy combined with immunization, and to explore and evaluate biomarkers related to efficacy, mechanism of action / resistance mechanism, and safety.

Conditions

Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.

  up to 48 weeks

Secondary Outcomes (4)

• Overall response rate (ORR)

  up to 48 weeks

• Disease control rate（DCR）

  up to 48 weeks

• Overall survival (OS)

  Baseline up to die

• Duration of Response (DOR)

  up to 48 weeks

Study Arms (2)

TQB2450 +Anlotinib+Docetaxel

EXPERIMENTAL

TQB2450（1200mg intravenous(iv). 3 weeks using a(q3w), day 1(d1)）+Anlotinib administered PO at day 1-14 every 3 weeks+Docetaxel（60mg/square meter intravenous(iv). 3 weeks using a(q3w), day 1(d1)）

Drug: TQB2450 +Anlotinib+Docetaxel

TQB2450 +Androtinib Placebo+Docetaxel

PLACEBO COMPARATOR

TQB2450 Injection（1200mg intravenous(iv). 3 weeks using a(q3w), day 1(d1)）+Anlotinib capsule placebo administered PO at day 1-14 every 3 weeks+Docetaxel Injection（60mg/square meter intravenous(iv),q3w, d1）

Drug: TQB2450 +Androtinib Placebo+Docetaxel

Interventions

TQB2450 +Anlotinib+Docetaxel 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 the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Anlotinib is a multi target receptor tyrosine kinase (RTK) inhibitor. It can inhibit VEGFR1, VEGFR2, VEGFR3, c-Kit, PDGFR β Activity. Docetaxel is a taxane based anti-tumor drug.

Also known as: TQB2450/Anlotinib/Docetaxel

TQB2450 +Anlotinib+Docetaxel

TQB2450 +Androtinib Placebo+Docetaxel 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 the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Androtinib Placebo Docetaxel is a taxane based anti-tumor drug.

Also known as: TQB2450/Anlotinib Placebo/Docetaxel

TQB2450 +Androtinib Placebo+Docetaxel

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 International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, patients with locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) NSCLC who are histologically proven to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy.
• years old ≤ age ≤ 75 years old; No gender limit; ECOG score 0-1 points; The expected survival period is ≥ 3 months.
• According to RECIST 1.1 standard, there should be at least one measurable lesion.
• Tumor resistance has progressed after receiving first-line treatment with immune checkpoint inhibitors (including PD-1 or PD-L1 monoclonal or dual antibodies) combined with platinum based drugs in the past. For neoadjuvant/adjuvant chemotherapy or radiotherapy or concurrent radiotherapy and chemotherapy, if the disease progresses during treatment or within 6 months after discontinuation of treatment, it should be considered as a first-line treatment plan.
• It is necessary to provide tumor tissue sections that have been diagnosed with advanced or metastatic NSCLC and have not undergone radiotherapy (at least 5 samples are required for PD-L1 testing of tumor tissue, but if testing has been conducted before the first line treatment, recognized test results from each participating center can be accepted.) Tumor tissue samples must be archived samples or freshly obtained samples within the first 12 months of randomization.
• Except for patients with squamous NSCLC, enrolled patients need to demonstrate the absence of EGFR gene sensitive mutations, ALK fusion oncogenes, or ROS1 fusion oncogenes. If it is adenosquamous cell carcinoma, stratification needs to be determined based on the dominant tissue composition.
• Good function of main organs
• Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study. Serum pregnancy or urine pregnancy tests should be negative within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period.
• The subjects voluntarily joined this study, signed an informed consent form, and had good compliance.

You may not qualify if:

• Tumor diseases and medical history:
• a) If there is a central nervous system metastasis before enrollment, enrollment can be made if all the following criteria are met: i. Previously received brain metastasis treatment and met all of the following criteria:
• ① Only supratentorial and cerebellar metastases are allowed (i.e. transfer to the midbrain, pons, medulla, or spinal cord is not allowed);
• ② No imaging evidence of new or enlarged brain metastases was found;
• ③ There are no symptoms of brain metastasis, and the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks before starting to use the investigational drug.
• Ii. Has not received brain metastasis treatment in the past and meets all of the following criteria:
• No more than 3 metastatic lesions; ② The total length and diameter of all lesions ≤ 1.5cm;
• There are no neurological symptoms caused by brain tissue compression;
• ④ Before starting to use the investigational drug, the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks.
• b) There were no active malignant tumors for ≤ 2 years before randomization. c) Central type squamous cell carcinoma with a cavity (primary in the main bronchus and around the hilum of the lungs).
• d) Imaging shows that the tumor invades large blood vessels, or the boundary between the tumor and the blood vessels is unclear, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies.
• e) (1) Severe bone damage caused by tumor bone metastasis, including pathological fractures of load-bearing bones (such as spinal vertebrae, pelvis, femur, tibia, phalanges, calcaneus, etc.) and spinal cord compression that occur within 6 months; (2) Imaging examination suggests the presence of three or more multiple bone metastases in the load-bearing bone.
• f) Patients with serous cavity (pleural, abdominal, or pericardial) effusion that requires repeated drainage to alleviate clinical symptoms (as determined by the researcher), or those who have received serous cavity effusion drainage for treatment purposes within 2 weeks prior to treatment.
• Previous anti-tumor treatment:
• Within 2 weeks before the start of the study treatment, he received traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug instructions.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (5)

The Central People's Hospital of Huizhou

Huizhou, Guangdong, 516001, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, 473000, China

RECRUITING

The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222000, China

RECRUITING

Weihai Municipal Hospital

Weihai, Shandong, 264299, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, 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

Central Study Contacts

Kai Li, doctor

CONTACT

18622221218; likai@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 21, 2023
• Study Start: April 12, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-04

Locations

CN (5)