Actively Recruiting
A Phase II/III Clinical Study on the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Perioperative Treatment of Resectable Stage II/III 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable stage II/III non-small cell lung cancer. This phase 2 clinical study involves patients eligible for curative surgery and aims to improve treatment outcomes using these combination therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive 3 to 4 cycles of TQB2450 combined with chemotherapy every 21 days, followed by surgery 4 to 6 weeks after the last dose. TQB2450 treatment continues for one year after surgery. In the second group, participants receive 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule over 21-day cycles, followed by surgery 4 to 6 weeks after the last dose, with treatment continuing for one year starting 4 weeks after surgery. During the study, participants undergo tumor tissue testing for PD-L1 and regular assessments including measuring major pathologic response up to 60 months. Secondary outcomes include overall survival, event-free survival, disease-free survival, pathological complete response, and surgical outcomes, with follow-up extending up to 60 months. Patients are monitored for safety, treatment effects, and surgery timing. The total participation time may last several years to evaluate long-term results.
CONDITIONS
Brief 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-IIIB (T3N2M0 only) non-small cell lung cancer eligible for curative R0 surgery after pathological diagnosis
- Age 18 to 80 years at informed consent signing; both men and women
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Predicted survival 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
- Major organs functioning well
- Women of reproductive age must agree to use effective contraception during the study and for 6 months after; men must agree to use effective contraception during the study and for 6 months after
- Voluntary participation with informed consent and good compliance
You will not qualify if you...
- Any other malignancies within the past 5 years
- Known genetic abnormalities with approved targeted drug therapy
- Cirrhosis or active hepatitis
- Cardio-cerebrovascular abnormalities
- Severe active infection within 4 weeks before treatment or unexplained fever over 38°C during screening
- Active tuberculosis within 1 year prior to enrollment
- Immunodeficiency diseases
- History of active autoimmune disease
- Organ transplant planned or received, or hematopoietic stem cell transplant within 60 days
- Use of immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization
- Severe infection of grade 4 or higher within 1 year before treatment
- Severe lung disease
- History of pituitary or adrenal dysfunction
- History of severe mental disorder
- History of drug abuse or alcoholism
- Participation in other drug clinical trials within 30 days
- Live attenuated vaccine within 28 days before randomization or planned during study
- Use of Chinese patent antitumor drugs within 2 weeks before treatment
- Major surgery within 4 weeks before treatment
- Other severe medical conditions or lab abnormalities increasing risk or interfering with study
- Expected insufficient compliance for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until completion of perioperative therapy
Participants receive TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in repeated 21-day cycles as perioperative treatment for non-small cell lung cancer.
Visits every 21 days for each treatment cycle
Duration - Up to 60 months after treatment
Participants are monitored for survival, disease progression, and long-term safety after treatment completion.
Periodic visits during follow-up up to 60 months
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
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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