Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anlotinib (10mg qd po d1-14, 21 days per cycle) and Penpulimab (200mg ivgtt d1)

Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.

Anlotinib Plus Penpulimab

Lin Wu, Professor

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase # study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of advanced non-small-cell lung cancer (NSCLC) participants who have progressed following prior PD-1 or PD-L1 Inhibitors treatment, to further improve the patient's PFS or OS.

This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the efficacy and safety of anlotinib plus docetaxel in advanced NSCLC patients (pts) who have progressed following prior PD-1 or PD-L1 Inhibitors treatment.

Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors

Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors: A Multicenter, Single-arm, Explorative Trial

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Objective Response Rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Progress free survival per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Overall Survival per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Disease Control Rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Safety as measured by the rate of AEs, SAEs and laboratory abnormalities

Henan Cancer Hospital

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Hunan Cancer Hospital

Immune System Diseases

Rare Diseases

Small Cell Lung Carcinoma

Hypersensitivity

Small Cell Lung Cancer

Nong Yang, PhD

Nong Yang

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase II ALTER1202 trial, patients who failed at least two kinds of systemic chemotherapy regimens (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 4.1 months and 7.3 months, the placebo group PFS and OS were 0.7 months and 4.9 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of sensitive relapsed small-cell lung cancer patients who were failure in the first-line treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the effectiveness and safety of Anlotinib Plus Penpulimab in patients of sensitive relapsed small-cell lung cancer.

Eligible patients will receive Anlotinib plus Penpulimab:

Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.

Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer

Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer: a Multicenter, Single-arm, Explorative Trial

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors	NCT05460481	Non Small Cell ...	Anlotinib Plus ...	18 Years - 75 Years	Hunan Cancer Hospital
Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors	NCT05460481	Non Small Cell ...	Anlotinib Plus ...	18 Years - 75 Years	Hunan Cancer Hospital
Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer	NCT05001971	Small Cell Lung...	Anlotinib Plus ...	18 Years - 75 Years	Hunan Cancer Hospital
Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors	NCT05460481	Non Small Cell ...	Anlotinib Plus ...	18 Years - 75 Years	Hunan Cancer Hospital
Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors	NCT05460481	Non Small Cell ...	Anlotinib Plus ...	18 Years - 75 Years	Hunan Cancer Hospital
Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer	NCT05001971	Small Cell Lung...	Anlotinib Plus ...	18 Years - 75 Years	Hunan Cancer Hospital

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