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

NCT04306926 | Unknown Phase 2

• 1 other identifier: TQB2450-II-05
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.

  Baseline up to 96 weeks

Secondary Outcomes (3)

• Objective response rate (ORR)

  Baseline up to 96 weeks

• Overall survival (OS)

  Baseline up to 96 weeks

• Disease control rate（DCR）

  Baseline up to 96 weeks

Study Arms (1)

TQB2450+SBRT

EXPERIMENTAL

SBRT three days before TQB2450.

Drug: TQB2450; Radiation: SBRT

Interventions

TQB2450 DRUG

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

TQB2450+SBRT

SBRT RADIATION

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

TQB2450+SBRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.
• \. Histologically or pathologically confirmed advanced non-small cell lung cancer.
• \. Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.
• \. Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.
• \. 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. (Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.
• \. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
• \. Has any severe and/or uncontrolled disease. 10. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
• \. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (4)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Tianjin Medical University Cancer institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Central Study Contacts

Hongqing Zhuang, Doctor

CONTACT

010-82264931; hongqingzhuang@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 13, 2020
• Study Start: March 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: May 30, 2023
• Last Updated: March 13, 2020

Record last verified: 2019-11

Locations

CN (4)