Randomized, Double-blind, Parallel Controlled, Multicenter Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Arotinib Capsules and Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer After Immune Resistance

Tianjin Medical University Cancer Institute and Hospital5 sites in 1 country148 target enrollmentApril 12, 2023

ConditionsNon-small-cell Lung Cancer

InterventionsTQB2450 +Anlotinib+Docetaxel TQB2450 +Androtinib Placebo+Docetaxel

DrugsTQB2450 +Anlotinib+Docetaxel TQB2450 +Androtinib Placebo+Docetaxel

Overview

Phase: Phase 2
Intervention: TQB2450 +Anlotinib+Docetaxel
Conditions: Non-small-cell Lung Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 148
Locations: 5
Primary Endpoint: Progression-Free Survival (PFS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 12, 2023

End Date

March 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•18 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.

Exclusion Criteria

•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).

Arms & Interventions

TQB2450 +Anlotinib+Docetaxel

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)）

Intervention: TQB2450 +Anlotinib+Docetaxel

TQB2450 +Androtinib Placebo+Docetaxel

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）

Intervention: TQB2450 +Androtinib Placebo+Docetaxel

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time Frame: up to 48 weeks

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.