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Twenty elderly patients (age≥65 years) with advanced non-squamous NSCLC with T790M negative after EGFR-TKI resistance will be enrollrd in this study. Participants will receive 4 to 6 cycles of cardunnilumab in combination with pemetrexed and anlotinib every 3 weeks, followed by maintenance treatment with cadonilimab plus anlotinib until disease progression, intolerable toxicity, withdrawal of consent, death, or other protocol-specified causes, whichever occurs first.

Cadonilimab was administered intravenously at a dose of 10 mg/kg every 3 weeks. Pemetrexed was administered intravenously at a dose of 500 mg/m² every 3 weeks Anlotinib was taken at doses of 10mg orally once daily for two weeks on a one-week-off schedule.

Cadonilimab was administered intravenously at a dose of 10 mg/kg every 3 weeks. Pemetrexed was administered intravenously at a dose of 500 mg/m² every 3 weeks Anlotinib was taken at doses of 10mg orally once daily for two weeks on a one-week-off schedule.

Cadonilimab plus Pemetrexed and Anlotinib

Fangfang Hou, Dr

Yadong Chen, Dr

Haibo Zhang, Prof

This study was designed to evaluate the efficacy and safety of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) in combination with pemetrexed and anlotinib for treatment of elderly patients with T790M-negative advanced non-squamous non-small cell lung cancer following resistance to EGFR-TKI.

This prospective study aims to enroll 20 elderly patients (age≥65 years) with advanced non-squamous NSCLC with T790M negative after EGFR-TKI resistance. Eligible patients will be given 4 to 6 cycles of cadonilimab plus pemetrexed and anlotinib, followed by maintenance treatment with cadonilimab plus anlotinib until disease progression, intolerable toxicity, withdrawal of consent, death, or other protocol-specified causes, whichever occurs first. Imaging assessments are scheduled to conduct every 6 weeks for the first year and then every 12 weeks thereafter. The follow-up of participants who discontinued treatment for reasons unrelated to disease progression will be continued, until the initiation of other anti-tumor therapy, disease progression, death, or the end of the study, whichever occurrs first.

Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI

A Phase II Clinical Trial Evaluating the Efficacy of Cadonilimab in Combination With Pemetrexed and Anlotinib for Treatment of Elderly Patients With T790M-negative Advanced Non-squamous Non-small Cell Lung Cancer Following Resistance to EGFR-TKI.

ORR (overall response rate) is defined as sum of complete response (CR) rate and partial response (PR) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 6 weeks for the first year and then every 12 weeks thereafter.

The time from the date of randomization to the date of disease progression, date of withdraw, or death from any cause, whichever occurs first.

DCR (disease control rate) is defined as sum of complete response (CR) rate, partial response (PR) rate and stable disease (SD) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 6 weeks for the first year and then every 12 weeks thereafter.

The time from the date of randomization to the date of withdraw or date of death from any cause, whichever occurs first

Akeso Pharmaceuticals, Inc.

Guangzhou University of Traditional Chinese Medicine

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI	NCT06277674	Non-small Cell ...	Cadonilimab plu...	65 Years -	Guangzhou University of Traditional Chinese Medicine
Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI	NCT06277674	Non-small Cell ...	Cadonilimab plu...	65 Years -	Guangzhou University of Traditional Chinese Medicine

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