A Phase 3, Randomized, Double-blind, Parallel Controlled, Multi-center Study to Compare the Safety and Efficacy of TQB2450 Injection Combined With Paclitaxel Injection and Carboplatin Injection Followed by TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus Tislelizumab Injection Combined With Paclitaxel Injection and Carboplatin Injection Followed by Tislelizumab Injection as a First-line Treatment on Patient With Advanced Squamous NSCLC.
Overview
- Phase
- Phase 3
- Intervention
- TQB2450
- Conditions
- Advanced Squamous Non-Small Cell Lung Carcinoma
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 570
- Locations
- 4
- Primary Endpoint
- Progression Free Survival (PFS)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is Phase 3, randomized, double-blind, parallel controlled study designed to evaluate the Progression Free Survive (PFS) of TQB2450 injection combined with Paclitaxel Injection and Carboplatin Injection Followed by TQB2450 injection combined with Anlotinib Hydrochloride Capsules versus Tislelizumab injection combined with Paclitaxel Injection and Carboplatin Injection followed by Tislelizumab injection in locally advanced (stage ⅢB/ⅢC) and metastatic or recurrent (Stage IV) squamous NSCLC subjects.The primary endpoint is PFS assessed by IRC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •According to the 8th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, the Tumour, node and metastasis (TNM) staging of lung cancer is locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) NSCLC patients.
- •Between the ages of 18-75 years (calculated based on the date of signing ICF); male or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥ 3 months.
- •According to the RECIST 1.1 standard, there is at least one measurable lesion. If the measurable lesion is located in the radiotherapy area, it should be clearly defined as a progressive state.
- •Patients who have not received systemic anti-tumor therapy for advanced, recurrent or metastatic diseases in the past. For those who have received adjuvant chemotherapy in the past, the interval between the recurrence time and the last adjuvant chemotherapy should be at least 6 months; The interval between the end of previous radiotherapy for chest and this treatment should be more than 6 months, and the interval between palliative radiotherapy for chest and this treatment should be more than 7 days.
- •Tumor tissue sections that have not undergone radiotherapy at or after the diagnosis of advanced or metastatic NSCLC must be provided.These are Used for PD-L1 expression detection.Tumor tissue samples must be archived samples or freshly obtained samples within 12 months before randomization.
- •main organ function is good, meet the following standards.
- •Routine blood examination standards (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening):
- •Absolute neutrophil count (ANC) ≥1.5×109 /L;
- •Platelets ≥100×109 /L;
- •Hemoglobin ≥90 g/L.
Exclusion Criteria
- •Tumor disease and medical history:
- •Brain metastasis exists before enrollment. Subjects meeting one of the following requirements can be included;
- •Have received brain metastasis treatment (surgery/radiotherapy) in the past and meet all the following criteria:
- •only supratentorial metastasis and cerebellar metastasis,
- •the condition needs to be stable for ≥ 2 weeks and no imaging evidence of new brain metastasis or brain metastasis expansion is found;
- •there is no brain metastasis symptom, and the subject must have stopped using corticosteroids/dehydrators for at least 2 weeks before starting to use the trial drug;
- •The patient has not received brain metastasis treatment in the past and meets all the following criteria:
- •the maximum diameter of the lesion is less than 2cm;
- •the condition needs to be stable for ≥ 2 weeks (no imaging evidence of new brain metastasis or expanded brain metastasis is found), and there is no neurological symptoms caused by brain tissue compression;
- •the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks before starting to use the test drug;
Arms & Interventions
TQB2450 Injection and Anlotinib Hydrochloride Capsules
In the induction stage: TQB2450 injection: 1200 mg, Intravenous drip on d1; Carboplatin injection: Area Under Curve 5mg/mL/min, Intravenous drip on d1; Paclitaxel injection: 175mg/m2, Intravenous drip on d1. The above schemes are repeated every three weeks. In the maintenance stage: TQB2450 injection: 1200 mg, Intravenous drip on d1; Anlotinib Hydrochloride Capsules: 10mg, orally administered every day from d1-d14. The above schemes are repeated every three weeks.
Intervention: TQB2450
TQB2450 Injection and Anlotinib Hydrochloride Capsules
In the induction stage: TQB2450 injection: 1200 mg, Intravenous drip on d1; Carboplatin injection: Area Under Curve 5mg/mL/min, Intravenous drip on d1; Paclitaxel injection: 175mg/m2, Intravenous drip on d1. The above schemes are repeated every three weeks. In the maintenance stage: TQB2450 injection: 1200 mg, Intravenous drip on d1; Anlotinib Hydrochloride Capsules: 10mg, orally administered every day from d1-d14. The above schemes are repeated every three weeks.
Intervention: Anlotinib hydrochloride capsule
Tislelizumab Injection
In the induction stage: Tislelizumab injection: 200 mg, Intravenous drip; Carboplatin injection: Area Under Curve 5mg/mL/min, Intravenous drip; Paclitaxel injection: 175mg/m2, Intravenous drip. The above schemes are repeated every three weeks. In the maintenance stage: Tislelizumab injection: 200 mg, Intravenous drip on d1 Placebo capsule: 0mg, orally administered every day from d1-d14. The above schemes are repeated every three weeks.
Intervention: Tislelizumab injection
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: Base line up to 2 years. The curative effect was evaluated every 6 weeks (42 days) in the first 54 weeks of treatment period; After 54 weeks, the efficacy was evaluated every 9 weeks (63 days).
Progression Free Survival (PFS) assessed by Independent Review Committee (IRC)
Secondary Outcomes
- The occurrence of abnormal QTc interval in 12 lead ECG(Baseline up to 2 years.)
- Overall survival (OS)(Baseline up to death event, assessed up to 2 years.)
- The occurrence of abnormal PR interval in 12 lead ECG(Baseline up to 2 years.)
- The occurrence of abnormal QRS interval in 12 lead ECG(Baseline up to 2 years.)
- Progression free survival (PFS)(From randomization to Progression disease, assessed up to 2 years.)
- Objective response rate (ORR)(From randomization to Progression disease, assessed up to 2 years.)
- Disease control rate (DCR)(From randomization to Progression disease, assessed up to 2 years.)
- Duration of response (DOR)(From randomization to Progression disease, assessed up to 2 years.)
- The severity of abnormal QTc interval in 12 lead ECG(Baseline up to 2 years.)
- Incidence of neutralizing antibody(Baseline up to 2 years.)
- The occurrence of all adverse events (AEs)(Baseline up to 2 years.)
- The severity of all adverse events (AEs)(Baseline up to 2 years.)
- The occurrence of abnormal heart rate in 12 lead Electrocardiograph (ECG)(Baseline up to 2 years.)
- The severity of abnormal PR interval in 12 lead ECG(Baseline up to 2 years.)
- The severity of abnormal heart rate in 12 lead Electrocardiograph (ECG)(Baseline up to 2 years.)
- The severity of abnormal QRS interval in 12 lead ECG(Baseline up to 2 years.)
- The severity of serious adverse events (SAEs)(Baseline up to 2 years.)
- Incidence of Antidrug antibody(Baseline up to 2 years.)
- The occurrence of abnormal QT interval in 12 lead ECG(Baseline up to 2 years.)
- The severity of abnormal QT interval in 12 lead ECG(Baseline up to 2 years.)
- The occurrence of serious adverse events (SAEs)(Baseline up to 2 years.)
- European organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30)(Baseline up to 2 years.)
- Quality of life questionnaire lung cancer module (QLQ-LC13)(Baseline up to 2 years.)
- EuroQol Five Dimensions Questionnaire (EQ-5D) assessment pro(Baseline up to 2 years.)