A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited-stage Small Cell Lung Cancer

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.16 sites in 1 country358 target enrollmentSeptember 2024

ConditionsSmall Cell Lung Cancer Limited Stage

InterventionsTQB2450+Anlotinib TQB2450 placebo + Anlotinib placebo

Overview

Phase: Phase 3
Intervention: TQB2450+Anlotinib
Conditions: Small Cell Lung Cancer Limited Stage
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 358
Locations: 16
Primary Endpoint: Progression-free survival (PFS) evaluated by the Independent Review Committee (IRC)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy.

Registry

clinicaltrials.gov

Start Date

September 2024

End Date

September 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
•Age: 18\~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance Status score: 0-1 points; expected survival of more than 6 months; weight \> 40 kg;
•Pathologically confirmed patients with limited stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG) stage);
•There was no evidence of metastatic disease by diagnostic quality enhanced CT of the neck, chest, abdomen, and pelvic cavity, and craniocerebral plain scan plus enhanced MRI (PET-CT is recommended before chemoradiotherapy. Bone scan should be performed if PET-CT is not performed before chemoradiotherapy. PET-CT must be performed during the screening period after chemoradiotherapy to rule out metastasis.);
•It is anticipated that no tumor resection will be required during the study（Patients who are not suitable for surgery or those who do not want surgery can be treated);
•Receive the chemoradiotherapy regimen prescribed below, unless an alternative is acceptable after consultation with the investigator:
•Four cycles of platinum-containing chemotherapy with concurrent or sequential radiotherapy were received, and these treatments had to be completed within 1 to 42 days of randomization and the first administration of the study drug;
•According to the standard treatment regimen at each study center, chemotherapy regimens must contain cisplatin/carboplatin drugs and etoposide administered intravenously
•For the standard Quaque Die radiotherapy regimen, the total radiation dose received was 60 Gy±10% (6-week regimen), and for the hyperfractionated Bis in die radiotherapy regimen, the total radiation dose received was 45 Gy (3-week regimen), and the dose was calculated based on the planned target area (PTV). Research centers are encouraged to follow the following doses of radiation to organs at risk：
•c.1 Average lung dose \<20 Gy and/or V20 must be \<35% c.2 Cardiac V50 \<25% d. If synchronous Cardiac resynchronization therapy is used, chest radiotherapy must be started no later than the first day of the 3rd cycle of chemotherapy; e. If sequential radiotherapy is used, thoracic radiotherapy should be preceded by at least 2 cycles of induction chemotherapy, with no more than 35 days between the end of the chemotherapy cycle and the start of radiotherapy;

Exclusion Criteria

•Tumor disease and history
•Present or present with other malignant tumors within 3 years. The following two conditions can be included: 5 consecutive years of disease-free survival (DFS) without any treatment for other malignancies; Cured of thyroid cancer, Cervical carcinoma in situ, Non-melanoma skin cancer and superficial bladder tumors【Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basal membrane)】;
•Complex small cell lung cancer confirmed by histopathology or cytopathology;
•Subjects with known central nervous system metastatic and/or cancerous meningitis;
•Malignant pleural effusion and pericardial effusion；
•Patients whose imaging (CT or MRI) shows that the tumor has invaded an important blood vessel or who are judged by the investigator to be highly likely to invade an important blood vessel during subsequent studies and cause a fatal hemorrhage;
•Previous antitumor therapy
•Within 2 weeks prior to the start of the study treatment, the patients were treated with proprietary Chinese medicines with anti-tumor indications specified in theNational Medical Products Administration approved drug specification (Including compound cantharidin capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule and so on);
•Patients who have received immunomodulatory drugs (e.g., interleukin-2, thymosin, lentinan, etc.) within 30 days before starting treatment；
•Prior treatment with an anti-programmed death-1, anti-Programmed cell death 1 ligand 1, or anti-Programmed death ligand-2 drug or against another irritating or co-inhibitory T cell receptor (e.g. cytotoxic T lymphocyte-associated antigen-4, OX 40, TNFRSF9, 4-1BB)；

Arms & Interventions

TQB2450+Anlotinib

TQB2450 injection: 1200 mg/time, intravenous infusion, day 1, every 3 weeks (Q3W); Anlotinib hydrochloride capsules: 8 mg/time, once a day (QD), for 2 weeks, stop for 1 week, oral before breakfast; (The starting dose of anlotinib hydrochloride is 8 mg, and an upward adjustment to 10 mg is allowed after two cycles.)

Intervention: TQB2450+Anlotinib

TQB2450 placebo + anlotinib placebo

TQB2450 injection placebo: 0 mg/time, intravenous drip, day 1; anlotinib hydrochloride capsule placebo: 0 mg/time, once a day (QD), for 2 consecutive weeks, stop for 1 week, oral administration before breakfast.

Intervention: TQB2450 placebo + Anlotinib placebo