A Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer

NCT ID: NCT04306926

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2023-05-30

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 enhancing immune response and has potential to treat various types of tumors.

Conditions

Advanced Oligometastatic Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2450+SBRT

SBRT three days before TQB2450.

Group Type: EXPERIMENTAL

TQB2450

Intervention Type: DRUG

TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.

SBRT

Intervention Type: RADIATION

Give according to the location of the lesion and clinical condition.

Interventions

TQB2450

TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.

Intervention Type: DRUG

SBRT

Give according to the location of the lesion and clinical condition.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

7.Understood and Signed an informed consent form.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer institute and Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Hongqing Zhuang, Doctor

Role: CONTACT

hongqingzhuang@163.com

010-82264931

Facility Contacts

Huiming Yu, Doctor

Role: primary

Hongqing Zhuang, Doctor

Role: primary

hongqingzhuang@163.com

Enmin Wang, Doctor

Role: primary

Zhiyong Yuan, Doctor

Role: primary

Other Identifiers

TQB2450-II-05

Identifier Type: -

Identifier Source: org_study_id