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

CTTQ

Status and phase: Enrolling; Phase 3

Conditions: Stage III Non-small-cell Lung Cancer

Treatments: Drug: Anlotinib; Drug: TQB2450(blank); Drug: TQB2450; Drug: Anlotinib(blank)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04325763

TQB2450-III-05

Details and patient eligibility

About

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.

Enrollment: 315 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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:

   1. Cavernous lung cancer.
   2. Has hemoptysis and maximum daily hemoptysis volume ≥ 2.5ml within 1 month 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.

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

4. 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.

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

6. EGFR gene mutations.

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

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

9. Has ≥grade 2 pneumonia.

10. 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.

11. Has multiple factors affecting oral medication.

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

13. 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.

14. 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.

15. 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.

17. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 3 patient groups, including a placebo group

TQB2450+Anlotinib

Experimental group

Description:

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).

Treatment:

Drug: Anlotinib

Drug: TQB2450

TQB2450+Anlotinib(blank)

Experimental group

Description:

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).

Treatment:

Drug: TQB2450

Drug: Anlotinib(blank)

TQB2450(blank)+Anlotinib(blank)

Placebo Comparator group

Description:

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).

Treatment:

Drug: TQB2450(blank)

Drug: Anlotinib(blank)