A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients

NCT06469879 | Not Yet Recruiting Phase 3

• 1 other identifier: TQB2450-ALTN-III-01
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 16

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.

Conditions

Small Cell Lung Cancer Limited Stage

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) evaluated by the Independent Review Committee (IRC)

  Random to the time of disease progression or death.

  up to 33 months

Secondary Outcomes (6)

• Progression-free survival (PFS) evaluated by researcher

  up to 33 months

• Overall survival (OS)

  About 5 years

• Objective mitigation rate (ORR)

  up to 33 months

• Remission duration (DOR)

  up to 33 months

• Disease control rate

  up to 33 months

Study Arms (2)

TQB2450+Anlotinib

EXPERIMENTAL

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.)

Drug: TQB2450+Anlotinib

TQB2450 placebo + anlotinib placebo

PLACEBO COMPARATOR

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.

Drug: TQB2450 placebo + Anlotinib placebo

Interventions

TQB2450+Anlotinib DRUG

TQB2450 injection test group, 1200 mg/time, strength: 600mg/20 mL, intravenous drip, day 1, every 3 weeks. Anlotinib hydrochloride capsules: 8 mg/time, strength: 10mg/capsule, 8mg/capsule, 6mg/capsule., 1 time a day (QD), continuous use for 2 weeks and stop for 1 week. TQB2450 Injection Placebo (control group): 0 mg/time, strength: 0mg/20 mL, Intravenous Drip, Day 1, every 3 weeks. Anlotinib hydrochloride capsule placebo: 0 mg/time, strength: 0mg/capsule, 1 time a day (QD), continuous use for 2 weeks and stop for 1 week.

TQB2450+Anlotinib

TQB2450 placebo + Anlotinib placebo DRUG

No drug substance is contained

TQB2450 placebo + anlotinib placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Precision radiotherapy techniques such as three-dimensional conformal radiotherapy, conformal intensity modulated radiotherapy and tomographic radiotherapy are adopted;
• Patients receiving radical platinum-based chemoradiotherapy must achieve complete response, partial response, or stable disease without disease progression;
• Prophylactic brain radiotherapy (PCI) is permitted according to the judgment of the investigator and the standard treatment at each study center, and must be performed after the completion of Cardiac resynchronization therapy, but it is allowed to be targeted at the last chemotherapy;
• The patient provided tumor tissue as far as possible for Programmed cell Death ligand 1 (PD-L1) expression level determination. Any available tumor tissue sample can be submitted: histology or cytology (if tissue samples are not available). Pathology reports of these specimens must also be provided;
• The patient was confirmed to have at least one measurable lesion according to RECIST 1.1 criteria prior to chemoradiotherapy;

You may not qualify if:

• 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)；
• In the past, he used bevacizumab,Anlotinib, Apatinib and other anti-angiogenic drugs；
• Received more than 4 courses of chemotherapy。Chemotherapy regiments other than etoposide and platinum are not allowed；
• Unmitigated toxic effects above Common Terminology Criteria for Adverse Events grade 1 due to any prior treatment（Hearing loss, hair loss, fatigue and abnormal lymphocyte count due to prior chemoradiotherapy were not included）；
• Subjects with ≥ grade 2 pulmonary inflammation after prior chemoradiotherapy;
• Combined disease and history

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (16)

Anhui Provincial Hospital

Hefei, Anhui, 23002, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

Guangxi Medical University Cancer Hospital

Nanjing, Guangxi, 530021, China

Location

Tangshan People's Hospital

Tangshan, Hebei, 63001, China

Location

Harbin Medical University cancer hospital

Harbin, Heilongjiang, 150081, China

Location

AnYang Tumor Hospital

Anyang, Henan, 455001, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441021, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Shanxi Provincial Cancer Hpspital

Taiyuan, Shanxi, 030000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

The Second People's Hospital of Neijiang

Neijiang, Sichuan, 641199, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Beijing Chest Hospital, Capital Medical University

Beijing, 101149, China

Location

Related Publications (1)

• Liu X, Yin X, Zhuang L, Wen J, Wei Z, Cui W, Yu M, Zhao K, Liu L, Kong L, Jiang L, Jing X, Zhu H, Wang X, Dong X, Yu J, Meng X. Efficacy and safety of TQB2450 combined with anlotinib as maintenance therapy for LS-SCLC after definitive concurrent or sequential chemoradiotherapy: a prospective phase Ib study. BMC Cancer. 2025 Mar 20;25(1):509. doi: 10.1186/s12885-025-13885-8.

  PMID: 40114144 DERIVED

Central Study Contacts

Jinming Yu, Doctor

CONTACT

13806406293; sdyujinming@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

CN (16)