Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.

Phase 3RecruitingNCT05922345

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.518 enrolled

Overview

To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

518

Conditions

Non-small Cell Lung Cancer

Interventions

TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subjects voluntarily joined the study, signed an informed consent form, and had good compliance * Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline; * Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy; * Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC; * Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation; * Confirmed to have at least one measurable lesion according to Response Evaluation Criteria In Solid Tumours（ RECIST 1.1） standard; * Adequate major organ function; Exclusion Criteria: * Patients who Have been diagnosed or currently had other malignant tumors; * Presence of epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations; * Factors affecting oral drugs; * Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment; * Hyperactive/venous thrombotic events within 6 months; * Subjects with any severe and/or uncontrolled disease; * Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs); * According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;

Locations (71)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

NOT_YET_RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Overall survival (OS)

The time from randomization to the date of death from any cause.

Time frame: From randomization to the time of death from any cause, assessed up to 36 months.

Secondary Outcomes

Progression-free survival (PFS) by investigator assessment

Time from randomization to objective disease progression or death from any cause, whichever occurs first.

Time frame: From the date of randomization to the date of first recorded progression or death from any cause, whichever comes first, assessed up to 36 months.

Objective response rate (ORR)

Refers to the percentage of subjects with complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.

Time frame: Time from the date of randomization to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months.

Disease Control Rate (DCR)

Refers to the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) ≥ 6 weeks as determined by the investigator according to RECIST 1.1.

Time frame: Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first.

Duration of response (DOR)

For subjects with a best response of complete response (CR) or partial response (PR), it is defined as the time from the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first.

Time frame: From the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first, assessed up to 36 months.

12-month survival rate (12-month OS rate)

The survival curve corresponds to the cumulative survival rate at 12 months

Time frame: Baseline up to 12-month

Health Questionnaire Form

Questionnaire: pain score：Place a check in the space that best reflects patients' health for the day.

Time frame: During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.

Effects on subjects' health-related quality of life

Questionnaire: Quality of life related scale (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 3rd edition).For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good.

Time frame: During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.

Patients with abnormal laboratory inspection indicators

Laboratory inspection indicators exceed the normal range

Time frame: From signing the informed consent form to the 30 days after the last dose.

Adverse event rate

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Time frame: From signing the informed consent form to the 30 days after the last dose.

Occurrence of anti-drug antibody (ADA)

Occurrence of ADA immunoglobulin

Time frame: Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.

Occurrence of neutralizing antibody (Nab)

Antibody preventing cells from being invaded by an antigen or infectious agent.

Time frame: Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.

Peak Concentration (Cmax)

The highest plasma concentration of a drug reached after administration.