A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04325763
• Collaborator: (none)
• Enrollment: 315
• Locations: 36
• Arms: 3
• Anticipated Duration (Months): 57.1
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell Lung Cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Condition or Disease	Intervention/Treatment	Phase
Stage III Non-small-cell Lung Cancer	Drug: TQB2450; Drug: Anlotinib; Drug: TQB2450(blank); Drug: Anlotinib(blank)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind and Imitation, Placebo Parallel Control, Multicentre Phase III Study of TQB2450 With or Without Anlotinib as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy
• Actual Study Start Date: May 27, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TQB2450+Anlotinib TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).	Drug: TQB2450; 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.; Drug: Anlotinib; a multi-target receptor tyrosine kinase inhibitor
Experimental: TQB2450+Anlotinib(blank) TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).	Drug: TQB2450; 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.; Drug: Anlotinib(blank); Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Placebo Comparator: TQB2450(blank)+Anlotinib(blank) TQB2450 0 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).	Drug: TQB2450(blank); Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day; Drug: Anlotinib(blank); Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC) [up to 33 months]

   PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.

Secondary Outcome Measures

1. PFS evaluated by Investigator [up to 33 months]

   PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.

2. Overall survival (OS) [up to 5 years]

   OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

3. Overall response rate (ORR) [up to 33 months]

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

4. Disease control rate（DCR） [up to 33 months]

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

5. Duration of response（DOR） [up to 33 months]

   The time when the participants first achieved complete or partial remission to disease progression.

6. PFS rate at month 6 [up to 6 months]

   The percentage of PFS at month 6

7. PFS rate at month 12 [up to 12 months]

   The percentage of PFS at month 12

8. Biomarkers, such as PD-L1 expression, etc. [up to 33 months]

   Tissue samples were collected during the screening period for pd-l1 analysis. Blood samples were collected for Tumor Mutation Burden (TMB) test before enrollment (within 7 days before medication) and after exit (±3 days).

9. Immunogenicity, such as the incidence of ADA [on day 1, 42, 105, 189 and 90 days after the last administration.]

   Degree of the immune response caused by the drug.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. 18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

2. Histologically or cytologically confirmed unresectable (Stage III) Non-Small Cell Lung Cancer.

3. At least has one measurable lesion before radiotherapy.

4. At least has one type of platinum-containing chemotherapy, Absence of progression after concurrent/sequential chemoradiotherapy.

5. Adequate laboratory indicators.

6. No pregnant or breastfeeding women, and a negative pregnancy test.

7. Understood and signed an informed consent form.

Exclusion Criteria:

1. Squamous cell carcinoma meets following conditions should be excluded:

2. Cavernous lung cancer.

3. Has hemoptysis and maximum daily hemoptysis volume ≥ 2.5ml within 1 month before the first administration.

4. Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-4.

5. Severe hypersensitivity occurs after administration of other monoclonal antibodies.

6. Diagnosed and/or treated additional malignancy within 5 years with the exception of cured basal cell carcinoma of skin ,carcinoma in situ of prostate,and carcinoma in situ of cervix.

7. Pathologically confirmed mixed small cell and non-small cell lung cancer.

8. EGFR gene mutations.

9. Has any active autoimmune disease or history of autoimmune disease.

10. After the early stage of chemoradiotherapy, the treatment toxicity ≥ grade 2 is not fully alleviated.

11. Has ≥grade 2 pneumonia.

12. Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose > 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.

13. Has multiple factors affecting oral medication.

14. Has active bleeding or a persistent decrease in hemoglobin.

15. Has any bleeding or bleeding events ≥grade 3 in the first 4 weeks before the first administration.

2.Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-4.

1. Has unhealed wounds, fractures, active gastric and duodenal ulcers, positive continuous fecal occult blood, ulcerative colitis in the first 4 weeks before the first administration.

2. Has received NMPA approved anti-tumor drugs or immunomodulatory drugs for systemic treatment within 2 weeks before the first administration.

16.Has a history of a hematological system transplantation or organ transplantation.

1. Has active diverticulitis、peritoneal abscess, intestinal obstruction. 18. Has any serious and/or uncontrollable disease. 19. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Chest Hospital	Hefei	Anhui	China	230000
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
3	Chongqing University Cancer Hospital	Chongqing	Chongqing	China	400000
4	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400000
5	Fujian Cancer Hospital	Fuzhou	Fujian	China	350000
6	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
7	The First Affiliated Hospital Sun Yat-Sen University	Guangzhou	Guangdong	China	510080
8	Yuebei People's Hospital	Shaoguan	Guangdong	China	512025
9	Affiliated Hospital of Guangdong Medical University	Zhangjiang	Guangdong	China	524000
10	The Fifth Affiliated Hospital Sun Yat-Sen University	Zhuhai	Guangdong	China	519000
11	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi	China	530200
12	The Fourth Hospital of Hebei medical University	Shijiazhuang	Hebei	China	050019
13	Anyang Cancer Hospital	Anyang	Henang	China	455000
14	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
15	Hubei Cancer Hospital	Wuhan	Hubei	China	430079
16	Hunan Cancer Hospital	Changsha	Hunan	China	410006
17	Xiangya Hospital Central South University	Changsha	Hunan	China	410008
18	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China	410013
19	Huaian First People's Hospital	Huai'an	Jiangsu	China	223300
20	Jiangsu Cancer Hospital	Nanjing	Jiangsu	China	210029
21	Jiangsu People's Hospital	Nanjing	Jiangsu	China	210029
22	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330012
23	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
24	Baoji Central Hospital	Baoji	Shanxi	China	721008
25	Shanxi Cancer Hospital	Taiyuan	Shanxi	China	030000
26	Xijing Hospital of Airforce Medical University	Xi'an	Shanxi	China	710000
27	First Affiliated Hospital of Xi'anjiantong University	Xi'an	Shanxi	China	710061
28	Tianjin Cancer Hospital	Tianjin	Tianjin	China	300060
29	The first Hospital of Zhengjiang Province	Hangzhou	Zhejiang	China	310000
30	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310005
31	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310006
32	Zhejiang Hospital	Hangzhou	Zhejiang	China	310013
33	Zhejiang People's Hospital	Hangzhou	Zhejiang	China	310014
34	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang	China	315000
35	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang	China	317000
36	Taizhou Central Hospital	Taizhou	Zhejiang	China	318000

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: NCT04325763
• Other Study ID Numbers: TQB2450-III-05
• First Posted: Mar 30, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• 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 31, 2022