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

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04306926
• Collaborator: (none)
• Enrollment: 59
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 38.9
• Patients Per Site: 14.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Oligometastatic Non-small Cell Lung Cancer	Drug: TQB2450; Radiation: SBRT	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Open-label, Single-arm, Phase II Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TQB2450+SBRT SBRT three days before TQB2450.	Drug: TQB2450; TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.; Radiation: SBRT; Give according to the location of the lesion and clinical condition.

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) [Baseline up to 96 weeks]

   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.

Secondary Outcome Measures

1. Objective response rate (ORR) [Baseline up to 96 weeks]

   Percentage of subjects achieving complete response (CR) and partial response (PR).

2. Overall survival (OS) [Baseline up to 96 weeks]

   OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

3. Disease control rate（DCR） [Baseline up to 96 weeks]

   Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.

1. Histologically or pathologically confirmed advanced non-small cell lung cancer.

2. Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.

3. Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.

4. 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.

1. 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.

2. 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.

3. (Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.

4. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

5. Has any severe and/or uncontrolled disease. 10. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.

6. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beijing	China	100142
2	Peking University Third Hospital	Beijing	Beijing	China	100191
3	Huashan Hospital Fudan University	Shanghai	Shanghai	China	200040
4	Tianjin Medical University Cancer institute and Hospital	Tianjin	Tianjin	China	300060

Sponsors and Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04306926
• Other Study ID Numbers: TQB2450-II-05
• First Posted: Mar 13, 2020
• Last Update Posted: Mar 13, 2020
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Mar 13, 2020