Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05922345

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.

Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-12-30

518

Participants Needed

71

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 to 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Body mass index (BMI) of 17 or higher at baseline
  • Histologically or cytologically confirmed inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) non-small cell lung cancer
  • Unable to receive radical concurrent chemoradiotherapy
  • Failed platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced, metastatic, or recurrent NSCLC
  • Received prior systemic therapy for unresectable or not amenable to radical chemoradiation disease
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Adequate major organ function
Not Eligible

You will not qualify if you...

  • Diagnosis or current presence of other malignant tumors
  • Presence of EGFR mutation, ALK fusion, ROS1 fusion, or other significant driver gene mutations
  • Conditions affecting oral drug absorption or use
  • Major surgery, incisional biopsy, traumatic injury, or uncured wound/fracture within 28 days before study treatment
  • Hyperactive or venous thrombotic events within 6 months
  • Severe or uncontrolled diseases
  • Previous treatment with other immunotherapies or tyrosine kinase inhibitors
  • Any concomitant diseases or conditions judged by the investigator to endanger safety or affect study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 71 locations

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230001

Not Yet Recruiting

2

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Not Yet Recruiting

3

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

4

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100050

Not Yet Recruiting

5

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, China, 100070

Not Yet Recruiting

6

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100080

Actively Recruiting

7

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Not Yet Recruiting

8

Beijing Chest Hospital Capital Medical University

Beijing, Beijing Municipality, China, 101149

Not Yet Recruiting

9

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Not Yet Recruiting

10

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Not Yet Recruiting

11

Three Gorges Hospital Affiliated to Chongqing University

Chongqing, Chongqing Municipality, China, 404100

Not Yet Recruiting

12

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China, 350014

Not Yet Recruiting

13

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361001

Not Yet Recruiting

14

Lanzhou University Second Hospital

Lanzhou, Gansu, China, 730030

Not Yet Recruiting

15

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China, 730050

Not Yet Recruiting

16

Meizhou People's Hospital

Meizhou, Guangdong, China, 514031

Not Yet Recruiting

17

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China, 515000

Not Yet Recruiting

18

Zhongshan City People's Hospital

Zhongshan, Guangdong, China, 528403

Not Yet Recruiting

19

Guigang people's hospital

Guigang, Guangxi, China, 537100

Not Yet Recruiting

20

Liuzhou people's hospital

Liuzhou, Guangxi, China, 545006

Not Yet Recruiting

21

Guangxi Medical University Afiliated Tomor Hospital

Nanning, Guangxi, China, 530021

Not Yet Recruiting

22

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China, 550002

Not Yet Recruiting

23

The Second Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China, 563006

Not Yet Recruiting

24

The Second Affiliated Hospital of Hainan Medical College

Haikou, Hainan, China, 570216

Not Yet Recruiting

25

Hainan Provincial People's Hospital

Haikou, Hainan, China, 570311

Not Yet Recruiting

26

Affiliated Hospital of Hebei University

Baoding, Hebei, China, 71000

Not Yet Recruiting

27

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, China, 67020

Not Yet Recruiting

28

Tangshan People's Hospital

Tangshan, Hebei, China, 63001

Not Yet Recruiting

29

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China, 163316

Not Yet Recruiting

30

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150081

Not Yet Recruiting

31

Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital)

Jiamusi, Heilongjiang, China, 154007

Not Yet Recruiting

32

Tong Ji Hospital Affiliated To Tongji Medical College HUST

Wuhan, Hubei, China, 430030

Not Yet Recruiting

33

Hubei Cancer Hospital (HBCH)

Wuhan, Hubei, China, 430079

Not Yet Recruiting

34

Xiangyang Central Hospital

Xiangyang, Hubei, China, 441021

Not Yet Recruiting

35

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China, 410011

Not Yet Recruiting

36

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

Not Yet Recruiting

37

Hunan Cancer Hospital

Changsha, Hunan, China, 410031

Not Yet Recruiting

38

Hunan Cancer Hospital

Changsha, Hunan, China, 410031

Not Yet Recruiting

39

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China, 17000

Not Yet Recruiting

40

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China, 210009

Not Yet Recruiting

41

Nantong Tumor Hospital

Nantong, Jiangsu, China, 226361

Not Yet Recruiting

42

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221002

Not Yet Recruiting

43

XuZhou Central Hospital

Xuzhou, Jiangsu, China, 221009

Not Yet Recruiting

44

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

Not Yet Recruiting

45

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110001

Not Yet Recruiting

46

Shenyang Tenth People'S Hospital

Shenyang, Liaoning, China, 110096

Not Yet Recruiting

47

The Second Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China, 710004

Not Yet Recruiting

48

The First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China, 710032

Not Yet Recruiting

49

The Second Affiliated Hospital of the Military Medical University of the PLA Air Force

Xi'an, Shaanxi, China, 710038

Not Yet Recruiting

50

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061

Not Yet Recruiting

51

Binzhou Medical University Hospital

Binzhou, Shandong, China, 256600

Not Yet Recruiting

52

Heze Municipal Hospital

Heze, Shandong, China, 274000

Not Yet Recruiting

53

The Second Hospital of Shandong University

Jinan, Shandong, China, 250000

Not Yet Recruiting

54

Shandong Cancer Hospital&Institute

Jinan, Shandong, China, 250117

Not Yet Recruiting

55

Affiliated Hospital of Jining Medical Uniwersity

Jining, Shandong, China, 272000

Not Yet Recruiting

56

Linyi Cancer Hospital

Linyi, Shandong, China, 276001

Not Yet Recruiting

57

Linyi People's Hospital

Linyi, Shandong, China, 276005

Not Yet Recruiting

58

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266071

Not Yet Recruiting

59

Changzhi People'S Hospital

Changzhi, Shanxi, China, 46000

Not Yet Recruiting

60

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China, 46000

Not Yet Recruiting

61

Linfen Central Hospital

Linfen, Shanxi, China, 41000

Not Yet Recruiting

62

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China, 30000

Not Yet Recruiting

63

Affiliated Hospital of North SIchuan Medical College

Nanchong, Sichuan, China, 637000

Not Yet Recruiting

64

The second people's hospital of neijiang

Neijiang, Sichuan, China, 641199

Not Yet Recruiting

65

TianJin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

66

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China, 300222

Not Yet Recruiting

67

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China, 830000

Not Yet Recruiting

68

Yunnan Cancer Hospital

Kunming, Yunnan, China, 650106

Not Yet Recruiting

69

The First Affliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Not Yet Recruiting

70

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310018

Not Yet Recruiting

71

Taizhou Enze Medical Center (Group)

Taizhou, Zhejiang, China, 318000

Not Yet Recruiting

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Research Team

D

Dingzhi Huang, Doctor

CONTACT

Y

Yi Hu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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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. | DecenTrialz