A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.

To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.

Start Date08 Jun 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20231281 / RecruitingPhase 3

评价 AL2846 胶囊联合 TQB2450 注射液对比多西他赛注射液在经免疫治疗失败的晚期非小细胞肺癌患者中有效性和安全性的多中心、随机、双盲、平行对照 III 期临床试验。

[Translation] This is a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial to evaluate the efficacy and safety of AL2846 capsules combined with TQB2450 injection versus docetaxel injection in patients with advanced non-small cell lung cancer who have failed immunotherapy.

主要目的：与多西他赛注射液对照，评价 AL2846 胶囊联合 TQB2450 注射液治疗经免疫治疗失败的晚期非小细胞肺癌患者的有效性。次要目的：与多西他赛注射液对照，评价 AL2846 胶囊联合 TQB2450 注射液治疗经免疫治疗失败的晚期非小细胞肺癌患者的安全性在经免疫治疗失败的晚期非小细胞肺癌受试者中评价 TQB2450 注射液的免疫原性。

[Translation]

Primary objective: To evaluate the efficacy of AL2846 capsule combined with TQB2450 injection in patients with advanced non-small cell lung cancer who have failed immunotherapy, compared with docetaxel injection. Secondary objective: To evaluate the safety of AL2846 capsule combined with TQB2450 injection in patients with advanced non-small cell lung cancer who have failed immunotherapy, compared with docetaxel injection. To evaluate the immunogenicity of TQB2450 injection in subjects with advanced non-small cell lung cancer who have failed immunotherapy.

Start Date05 Jun 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT05745363 / RecruitingPhase 1/2

Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsule in Iodine-resistant Differentiated Thyroid Cancer With Previous TKI Treatment Failure

This is a Phase Ib clinical trial to evaluate the efficacy and safety of AL2846 capsule in iodine-refractory differentiated thyroid cancer that has failed previous TKI treatment. The trial is planned to enroll 20 subjects. The trial is a single-arm, multi-center, open label clinical study. Objective response rate (ORR) is the primary endpoint.

Start Date24 Feb 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Vilzemetkib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	05 Jun 2023
Refractory Differentiated Thyroid Gland Carcinoma	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	24 Feb 2023
Ovarian Cancer	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	15 Feb 2023
Advanced Malignant Solid Neoplasm	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	03 Feb 2023
Advanced Malignant Solid Neoplasm	Phase 2	CN	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	03 Feb 2023
Neoplasms	Phase 2	CN	Advenchen Laboratories LLC	30 Jan 2022
Neurofibromatosis 1	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	07 Sep 2021
Neurofibrosarcoma	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	07 Sep 2021
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	24 Sep 2020
Bone metastases	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	24 Sep 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05745363 (ESMO2024) Manual	Phase 1	Refractory Differentiated Thyroid Gland Carcinoma	28	AL2846 90mg	aguriquofm(yuepyqekfy) = cjseoepusn auftssdile (ipejmpkrhh ) View more	Positive	16 Sep 2024
NCT06116240 (WCLC2024) Manual	Phase 1	Non-Small Cell Lung Cancer Second line	44	TQB2450 AL2846 inhibitor) 1200mg/Q3W	yjpomezuqh(tdrrbntvzq) = fwppktybzt mnecgnistp (msqlxafioz ) View more	Positive	09 Sep 2024
CTR20201021 (ASCO2021)	Phase 1	Locally Advanced Pancreatic Adenocarcinoma	15	AL2846 + Gemcitabine	kldiaelfpj(uxqkjyfqxj) = xfrugdqfll tmtxcziqtu (ryrhaieamg ) View more	-	28 May 2021

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