Trial Title:
A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients
NCT ID:
NCT06469879
Condition:
Small Cell Lung Cancer Limited Stage
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2450+Anlotinib
Description:
TQB2450 injection test group, 1200 mg/time, strength: 600mg/20 mL, intravenous drip, day
1, every 3 weeks. Anlotinib hydrochloride capsules: 8 mg/time, strength: 10mg/capsule,
8mg/capsule, 6mg/capsule., 1 time a day (QD), continuous use for 2 weeks and stop for 1
week.
TQB2450 Injection Placebo (control group): 0 mg/time, strength: 0mg/20 mL, Intravenous
Drip, Day 1, every 3 weeks. Anlotinib hydrochloride capsule placebo: 0 mg/time, strength:
0mg/capsule, 1 time a day (QD), continuous use for 2 weeks and stop for 1 week.
Arm group label:
TQB2450+Anlotinib
Intervention type:
Drug
Intervention name:
TQB2450 placebo + Anlotinib placebo
Description:
No drug substance is contained
Arm group label:
TQB2450 placebo + anlotinib placebo
Summary:
This study is a randomized, double-blind, placebo-controlled phase III clinical study to
evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance
therapy in patients with limited-stage small cell lung cancer who have not progressed
after chemoradiotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The subjects voluntarily joined the study, signed the informed consent, and the
compliance was good;
- Age: 18~75 years old (when signing the informed consent form); Eastern Cooperative
Oncology Group Performance Status score: 0-1 points; expected survival of more than
6 months; weight > 40 kg;
- Pathologically confirmed patients with limited stage small cell lung cancer
(according to the Veterans Administration Lung Study Group (VALG) stage);
- There was no evidence of metastatic disease by diagnostic quality enhanced CT of the
neck, chest, abdomen, and pelvic cavity, and craniocerebral plain scan plus enhanced
MRI (PET-CT is recommended before chemoradiotherapy. Bone scan should be performed
if PET-CT is not performed before chemoradiotherapy. PET-CT must be performed during
the screening period after chemoradiotherapy to rule out metastasis.);
- It is anticipated that no tumor resection will be required during the study（Patients
who are not suitable for surgery or those who do not want surgery can be treated);
- Receive the chemoradiotherapy regimen prescribed below, unless an alternative is
acceptable after consultation with the investigator:
1. Four cycles of platinum-containing chemotherapy with concurrent or sequential
radiotherapy were received, and these treatments had to be completed within 1
to 42 days of randomization and the first administration of the study drug;
2. According to the standard treatment regimen at each study center, chemotherapy
regimens must contain cisplatin/carboplatin drugs and etoposide administered
intravenously
3. For the standard Quaque Die radiotherapy regimen, the total radiation dose
received was 60 Gy±10% (6-week regimen), and for the hyperfractionated Bis in
die radiotherapy regimen, the total radiation dose received was 45 Gy (3-week
regimen), and the dose was calculated based on the planned target area (PTV).
Research centers are encouraged to follow the following doses of radiation to
organs at risk：
c.1 Average lung dose <20 Gy and/or V20 must be <35% c.2 Cardiac V50 <25% d. If
synchronous Cardiac resynchronization therapy is used, chest radiotherapy must be
started no later than the first day of the 3rd cycle of chemotherapy; e. If
sequential radiotherapy is used, thoracic radiotherapy should be preceded by at
least 2 cycles of induction chemotherapy, with no more than 35 days between the end
of the chemotherapy cycle and the start of radiotherapy;
- Precision radiotherapy techniques such as three-dimensional conformal radiotherapy,
conformal intensity modulated radiotherapy and tomographic radiotherapy are adopted;
- Patients receiving radical platinum-based chemoradiotherapy must achieve complete
response, partial response, or stable disease without disease progression;
- Prophylactic brain radiotherapy (PCI) is permitted according to the judgment of the
investigator and the standard treatment at each study center, and must be performed
after the completion of Cardiac resynchronization therapy, but it is allowed to be
targeted at the last chemotherapy;
- The patient provided tumor tissue as far as possible for Programmed cell Death
ligand 1 (PD-L1) expression level determination. Any available tumor tissue sample
can be submitted: histology or cytology (if tissue samples are not available).
Pathology reports of these specimens must also be provided;
- The patient was confirmed to have at least one measurable lesion according to RECIST
1.1 criteria prior to chemoradiotherapy;
- Having an adequate Pulmonary function test, defined as Forced expiratory volume in
one second > 50% of predicted normal expiratory volume and Diffusing capacity of the
lung for carbon monoxide (DLCO) > 40% of predicted normal. For subjects without
diffusing capacity of the lungs for carbon monoxide measurements, adequate oxygen
transport is considered if the pulse oxygen saturation (O2 saturation) measured in
indoor air is ≥ 90%.
Exclusion Criteria:
- Tumor disease and history
1. Present or present with other malignant tumors within 3 years. The following
two conditions can be included: 5 consecutive years of disease-free survival
(DFS) without any treatment for other malignancies; Cured of thyroid cancer,
Cervical carcinoma in situ, Non-melanoma skin cancer and superficial bladder
tumors【Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor
infiltrating basal membrane)】;
2. Complex small cell lung cancer confirmed by histopathology or cytopathology;
3. Subjects with known central nervous system metastatic and/or cancerous
meningitis;
4. Malignant pleural effusion and pericardial effusion；
5. Patients whose imaging (CT or MRI) shows that the tumor has invaded an
important blood vessel or who are judged by the investigator to be highly
likely to invade an important blood vessel during subsequent studies and cause
a fatal hemorrhage;
- Previous antitumor therapy
1. Within 2 weeks prior to the start of the study treatment, the patients were
treated with proprietary Chinese medicines with anti-tumor indications
specified in theNational Medical Products Administration approved drug
specification (Including compound cantharidin capsule, Kangai injection,
Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule,
Xiaoaiping tablet/injection, Huachansu capsule and so on);
2. Patients who have received immunomodulatory drugs (e.g., interleukin-2,
thymosin, lentinan, etc.) within 30 days before starting treatment；
3. Prior treatment with an anti-programmed death-1, anti-Programmed cell death 1
ligand 1, or anti-Programmed death ligand-2 drug or against another irritating
or co-inhibitory T cell receptor (e.g. cytotoxic T lymphocyte-associated
antigen-4, OX 40, TNFRSF9, 4-1BB)；
4. In the past, he used bevacizumab,Anlotinib, Apatinib and other anti-angiogenic
drugs；
5. Received more than 4 courses of chemotherapy。Chemotherapy regiments other than
etoposide and platinum are not allowed；
6. Unmitigated toxic effects above Common Terminology Criteria for Adverse Events
grade 1 due to any prior treatment（Hearing loss, hair loss, fatigue and
abnormal lymphocyte count due to prior chemoradiotherapy were not included）；
7. Subjects with ≥ grade 2 pulmonary inflammation after prior chemoradiotherapy;
- Combined disease and history
1. Cirrhosis, active hepatitis*:
Active hepatitis（Hepatitis B reference: HBsAg positive, and Hepatitis B virus
DNA detection value exceeds the upper limit of normal value; Hepatitis C
reference: Hepatitis C virus antibody positive and Hepatitis C (HCV) virus
titer test values above the upper limit of normal); Note: Participants who are
eligible for enrollment, hepatitis B surface antigen positive or core antibody
positive, and hepatitis C patients need continuous antiviral therapy to prevent
virus activation.
2. Patients with renal failure requiring hemodialysis or peritoneal dialysis have
pre-existing or existing nephrotic syndrome or chronic nephritis
3. Cardio-cerebrovascular abnormalities:
c.1 Have grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including
QT Interval Correction ≥450ms in men, QT Interval Correction ≥470ms in women), and
grade 2 congestive heart failure (NYHA rating); c.2 Severe arterial/venous
thrombosis events, such as cerebrovascular accidents (including temporary ischemic
attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and
pulmonary embolism, etc., occurred within 6 months; c.3 After two or more
medications, blood pressure control remained unsatisfactory (systolic ≥150 mmHg or
diastolic ≥90 mmHg) d. History of immunodeficiency: d.1 A history of
immunodeficiency, including HIV positive or other acquired or congenital
immunodeficiency diseases, or a history of organ transplantation; d.2 Active
autoimmune disease requiring systemic treatment (such as use of disease-modifying
drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to
study treatment initiation(Such as, but not limited to: autoimmune hepatitis,
interstitial pneumonia, enteritis, vasculitis, nephritis; Subjects with asthma
requiring medical intervention with bronchodilators were not included). Hormone
replacement therapy (such as thyroxine, insulin, or physiological corticosteroids
for adrenal or pituitary insufficiency) may not be considered systemic treatment; e.
Have been diagnosed with an immune deficiency or are receiving systemic
glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/
day prednisone or other therapeutic hormone) and continue to use within 2 weeks
prior to initial administration; f. Patients with active tuberculosis within 1 year
prior to enrollment; Participants with a history of active pulmonary tuberculosis
infection before 1 year were required to provide clear evidence of cure. If
tuberculosis was suspected during the screening period, the patients could be
enrolled only after being excluded by chest radiography or chest CT, sputum and
clinical symptoms;
- Study live attenuated vaccine vaccination history within 28 days before the start of
treatment or planned live attenuated vaccine vaccination during the study period;
- Had participated in other anti-tumor drug clinical trials within 4 weeks before the
first drug use, and only those who had not used drugs were not subject to the 4-week
time limit.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
23002
Country:
China
Contact:
Last name:
Dong Qian, Doctor
Phone:
18202269589
Email:
qiandong@ustc.edu.cn
Facility:
Name:
Lanzhou University Second Hospital
Address:
City:
Lanzhou
Zip:
730030
Country:
China
Contact:
Last name:
Pengfei Sun, Doctor
Phone:
13919485464
Email:
sunpengfeiby@163.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanjing
Zip:
530021
Country:
China
Contact:
Last name:
Xinbin Pan, Master
Phone:
13471171468
Email:
panxinbin@gxmu.edu.cn
Facility:
Name:
Tangshan People's Hospital
Address:
City:
Tangshan
Zip:
63001
Country:
China
Contact:
Last name:
Junquan Yang, Doctor
Phone:
19131829092
Email:
13313059092@163.com
Facility:
Name:
Harbin Medical University cancer hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Contact:
Last name:
BaoGang Liu, Doctor
Phone:
13804552752
Email:
baogangliu1962@163.com
Facility:
Name:
AnYang Tumor Hospital
Address:
City:
Anyang
Zip:
455001
Country:
China
Contact:
Last name:
Yaowen Zhang, Doctor
Phone:
15837207287
Email:
zhangyaowen621@126.com
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xiangyang
Zip:
441021
Country:
China
Contact:
Last name:
Tienan Yi, Master
Phone:
13871658799
Email:
1721905183@qq.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Contact:
Last name:
Hui Wang, Doctor
Phone:
13973135460
Email:
wanghui@hnca.org.cn
Contact backup:
Last name:
Huai Liu, Doctor
Phone:
18874831511
Email:
liuhuai@hnca.org.cn
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Contact:
Last name:
Bo Jin, Doctor
Phone:
13604923020
Email:
jb_cmu@126.com
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250063
Country:
China
Contact:
Last name:
Yufeng Cheng, Doctor
Phone:
18560081666
Email:
qlcyf@163.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Jinming Yu, Doctor
Phone:
13806406293
Email:
sdyujinming@126.com
Facility:
Name:
Shanxi Provincial Cancer Hpspital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Contact:
Last name:
Jie Li, Master
Phone:
18635169066
Email:
lijie942003@163.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Contact:
Last name:
Xiaomin Dang, Doctor
Phone:
18991232795
Email:
dxming112@163.com
Facility:
Name:
The Second People's Hospital of Neijiang
Address:
City:
Neijiang
Zip:
641199
Country:
China
Contact:
Last name:
Yu Liu, Master
Phone:
13698308655
Email:
13278258@qq.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Contact:
Last name:
YongLing Ji, Doctor
Phone:
13958085251
Email:
jiyl@zjcc.org.cn
Facility:
Name:
Beijing Chest Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
101149
Country:
China
Contact:
Last name:
Tongmei Zhang, Doctor
Phone:
13683016715
Email:
tongmeibj@163.com
Start date:
September 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06469879
