Actively Recruiting
A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2023-06-29
58
Participants Needed
10
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a clinical study on the efficacy and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable non-small cell lung cancer. The part I study was planned to enroll 58 subjects, 1:1 randomized into two cohorts. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued for 1 year starting 4 weeks after surgery.
CONDITIONS
Official Title
A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage II to IIIB (T3N2M0 only) non-small cell lung cancer eligible for curative R0 surgery after pathological diagnosis
- Age 18 years or older at informed consent
- Both men and women
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Predicted survival of at least 3 months
- At least one measurable lesion per RECIST 1.1 within 28 days before treatment
- No prior systemic antitumor therapy including radiotherapy, chemotherapy, or immunotherapy
- Agree to provide fresh or recent tumor tissue for PD-L1 testing
- Adequate function of major organs
- Women of childbearing potential agree to use effective contraception during study and for 6 months after; negative pregnancy test within 7 days before enrollment
- Men agree to use effective contraception during study and for 6 months after
- Voluntarily agree to participate and sign informed consent with good compliance
You will not qualify if you...
- Presence of other malignancies within past 5 years
- Known genetic abnormalities with approved targeted drug therapy
- Cirrhosis or active hepatitis
- Cardio-cerebrovascular abnormalities
- Severe active infection within 4 weeks prior to treatment or unexplained fever above 38.0°C during screening
- Active tuberculosis within 1 year prior to enrollment
- Immunodeficiency disease
- History of active autoimmune disease
- History or preparation for organ or hematopoietic stem cell transplant within 60 days prior to treatment
- Use of immunosuppressive therapy within 2 weeks before randomization
- Severe infection grade 4 or higher within 1 year prior to treatment
- Severe lung disease
- History of pituitary or adrenal dysfunction
- Severe mental disorder history
- History of drug abuse or alcoholism
- Participation in other drug clinical trials within 30 days
- Live attenuated vaccine within 28 days prior to randomization or planned during study
- Recent use of Chinese patent drugs with antitumor indications within 2 weeks
- Major surgery within 4 weeks prior to treatment
- Other severe medical conditions or abnormalities increasing participation risks or interfering with results
- Estimated insufficient compliance to participate in the clinical study
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100027
Actively Recruiting
3
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
4
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149
Not Yet Recruiting
5
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
6
Weifang People's Hospital
Weifang, Shandong, China, 261044
Actively Recruiting
7
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
8
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
9
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300070
Not Yet Recruiting
10
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China, 300222
Actively Recruiting
Research Team
S
Shugeng Gao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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