RecruitingPhase 1Phase 2NCT04237805

A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients

A Phase I/II, Multi-center Clinical Study: Dose-finding Phase I Study of Foritinib Succinate in Advanced ALK-positive NSCLC Patients and Phase II Study of Foritinib Succinate in ALK or ROS1-positive NSCLC Patients

Sponsor

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Enrollment

280 participants

Start Date

Nov 14, 2016

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Advanced Cancer Lung Cancer, Nonsmall Cell

Summary

The study comprises two phases: phase I dose escalation (including PK run-in period and treatment period) and phase II study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called SAF-189s in patients with non-small cell lung cancer (NSCLC) that has a specific genetic change — either an ALK or ROS1 mutation — and has progressed despite prior treatment. **You may be eligible if...** - You have been diagnosed with advanced non-small cell lung cancer (Stage IIIB or IV) - Your cancer has a confirmed ALK or ROS1 gene mutation - You have progressed on at least one prior targeted therapy (ALK or ROS1 inhibitor) or have never received one (for some arms) - Your cancer has at least one measurable lesion on imaging - You are in reasonably good overall health **You may NOT be eligible if...** - Your lung cancer does not have an ALK or ROS1 mutation - You have already received 4 or more prior lines of treatment - You have serious organ problems (heart, liver, kidneys) that would make treatment unsafe - You are pregnant or breastfeeding - You have active brain metastases requiring urgent treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSAF-189s

20mg，40mg，80mg，120mg，160mg，210mg，once daily

Locations(41)

The first affiliated hospital of China medical university

Shenyang, Liaoning, China

he First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Shulan (Hangzhou) Hospital

Hangzhou, Zhengjiang, China

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

General Hospital of Xuzhou Mining Group

Xuzhou, Jiangsu, China

Jilin Cancer Hospital

Jilin, Jilin, China

Yanbian University Affiliated Hospital

Yanji, Jilin, China

Linyi Cancer Hospital

Linyi, Shandong, China

Jieyang Peoples Hospital

Jieyang, Shanxi, China

The second peoples hospital of Neijiang

Neijiang, Sichuan, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Shanghai Chest Hospital,Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital, Medical School of Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Jinan Central Hospital

Jinan, Shandong, China

No. 960 Hospital of the Joint Service Support Force of Chinese People's Liberation Army

Jinan, Shandong, China

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Guangdong Province People's General Hospital

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhengzhou Central Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Zhengzhou, Henan, China

The second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Chest Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Hubei Cancer Hospital

Wuhan, Hubei, China

SIR RUN RUN SHAW HOSPITAL Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Tianjin Peoples Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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