Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Irinotecan

Tyrosine Kinase Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Tyrosine

TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 21 consective days as a treatment cycle;Anlotinib hydrochloride capsules 12mg, once a day for 2 consecutive weeks and stop for 1 week.

TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 28 consecutive days as a treatment cycle. Irinotecan Hydrochloride Injection 100 mg/m2 intravenous infusion on D1、D8 and D15, a total of 4-6 cycles.

TQB3616 capsules

A multi-target receptor tyrosine kinase inhibitor

Anlotinib Hydrochloride capsules

Irinotecan Hydrochloride for Injection

Yongsheng Li, Doctor

Jianghong Wang, Master

Dong Wang

Hongmei Yue, Master

Yu Zhang, Doctor

Haichuan Su, Doctor

Wenxiu Yao, Doctor

Runxiang Yang, Doctor

This is an open, multi-cohort, exploratory phase II study on the safety and efficacy of TQB3616 combined with Anlotinib hydrochloride capsules or standard chemotherapy in the treatment of advanced lung cancer.

A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer

Percentage of participants achieving complete response (CR) and partial response (PR).

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

The time when the participants first achieved CR or PR to disease progression or death from any cause.

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hormones

Fulvestrant

Mitogens

The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.

Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days.

The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.

Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days.

The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.

The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.

TQB3616-matching placebo

Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days.

Fluvestrin injection

Zefei Jiang, Doctor

Yongmei Yin

Zefei Jiang

Huiping Li

This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen receptor-positive, HER2-Negative Advanced Breast Cancer. Approximately 287 women will be randomized to either TQB3616 plus fulvestrant or TQB3616-matching placebo plus fulvestrant. Randomization will follow a 2:1 randomization ratio,the experimental is 191; the Placebo Comparator is 96.

TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail

A Phase III,Randomized, Double-blind, Paralle, Multi-center Study to Evaluate the Efficacy and Safety of TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Participants With Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor(EGFR) 2-Negative Advanced Breast Cancer

Progression-free survival (First-time progression of disease/ recurrence /death)

Progression-free survival（First-time progression of disease/ recurrence /death）

Percentage of subjects with complete (CR) or partial response (PR) or stable disease (SD)（ Baseline up to progression of disease/ recurrence /death）

Duration of Response(Baseline up to progression of disease/ recurrence /death)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer	NCT04924192	Advanced Lung C...	TQB3616 capsule... Anlotinib Hydro... Irinotecan Hydr...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail	NCT05375461	HR-positive,HER...	TQB3616 capsule... TQB3616-matchin... Fluvestrin inje...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail	NCT05375461	HR-positive,HER...	TQB3616 capsule... TQB3616-matchin... Fluvestrin inje...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer	NCT04924192	Advanced Lung C...	TQB3616 capsule... Anlotinib Hydro... Irinotecan Hydr...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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