Status:
UNKNOWN
A Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Oligometastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus e...
Eligibility Criteria
Inclusion
- 1\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.
- 2\. Histologically or pathologically confirmed advanced non-small cell lung cancer.
- 3\. Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.
- 4\. Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.
- 5\. Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
- Understood and Signed an informed consent form.
Exclusion
- 1\. Has used against PD-1, PD-L1 and other related immunotherapeutic drugs. 2.Has mutations in (epidermal growth factor receptor)EGFR, (anaplastic lymphoma kinase)ALK, (c-ros oncogene 1 receptor kinase)ROS1 or T790M and not resistant to targeted drug.
- 3\. Has severe hypersensitivity reaction to other monoclonal antibodies. 4. Has diagnosed and/or treated additional malignancy within 5 years prior to the first administration.Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.
- 5\. Has any active autoimmune disease or a history of autoimmune disease. 6. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage \> 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
- 7\. (Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.
- 8\. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
- 9\. Has any severe and/or uncontrolled disease. 10. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
- 11\. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04306926
Start Date
March 1 2020
End Date
May 30 2023
Last Update
March 13 2020
Active Locations (4)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040
4
Tianjin Medical University Cancer institute and Hospital
Tianjin, Tianjin Municipality, China, 300060