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Osimertinib

The investigational product Glumetinib will be orally administrated when fasting at dose level of 300mg QD and Osimertinib will be orally administrated when fasting at dose level of 80mg QD

Phase Ib is a dose escalation study, the initial dose of Glumetinib is 300mg, then will be escalated to 400mg，according to the result of Phase Ib， will confirm the RP2D

Glumetinib

Shun LU, Doctor

Ziping Wang, Doctor

Yongqian Shu, Doctor

Dingzhi Huang, Doctor

Yiping Zhang, Doctor

Jianying Zhou, Doctor

To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.

Phase Ib: Glumetinib 300mg Combined With Osimertinib 80mg, Qd ,oral

Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors

Open Label, Multicenter Phase Ib / II Study of Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors

the sum ratio of partial response and complete response(determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1)

the sum ratio of partial response and complete response(assessed as per investigators)

The time from the partial response and complete response of patient to patient progressive disease or death

The time from the patient first dose to death

Haihe Biopharma Co., Ltd.

Phase Ib: SCC244 300mg, QD Phase II: SCC244 300mg, QD

The investigational product will be orally administrated when fasting at dose level of 300mg QD

Jaspreet Singh, Grewal

Stephen, Huang

Lejie Cao

Xuhong Min

Ziping Wang

Jian Fang

Li Zhang

Xiaoyan Lin

Chengzhi Zhou

Qitao Yu

Wen Dong

Yan Yu

Yanqiu Zhao

Yanping Hu

Xiaorong Dong

Min Li

Meiqi Shi

Yongqian Shu

Wei Zhang

Jiuwei Cui

Xiaoling Li

Aimin Zang

Xiuwen Wang

Chong Bai

Jialei Wang

Shun Lu

Lu Li

Dingzhi Huang

Diansheng Zhong

Jianying Zhou

Yiping Zhang

Lin Wu

Xingya Li

Naoyuki Nogami

Isamu Okamoto

Terufumi Kato

Hiroshi Tanaka

Hidetoshi Hayashi, Dr

Kazumi Nishino

Jun Sakakibara

Haruki Kobayashi

Koichi Goto

Yuki Shinno

Masahiro Kodani

James Zhou, MD

Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer

Phase Ib (China only):

Approximately 90 patients

Phase Ⅱ (globally):

Approximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only)

Phase Ib study population

Approximately 90 patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV) including pulmonary sarcomatoid carcinoma (PSC). All patients should carry at least one of the following MET alterations (confirmed by local or central laboratory):

* Patients with METex14 skipping mutation who had previously treated by other MET inhibitor(s)
* Patients with METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC
* Patients with MET amplification (GCN ≥ 4 or MET/CEP7 ratio ≥ 2)
* Patients with MET over-expression (IHC2+) Phase II - Safety Run-in Population (US only) A minimum of 6 patients who meeting the eligibility for either Phase Ib or Phase II.

Phase II study population (globally) Approximately 78 evaluable patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV, including PSC) harboring METex14 skipping mutation that have been pre-screened by local or Sponsor-designated central laboratory, who are not eligible for chemotherapy or refuse of chemotherapy after well-informed or have failed one or two prior lines of systemic therapies and have not had prior MET inhibitor for the advanced NSCLC.

Phase Ib：300 mg QD Glumetinib Phase II：300 mg QD Glumetinib

Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer

A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glumetinib (SCC244), a Selective MET Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer Harboring MET-alterations

ORR as determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors	NCT04338243	Negative T790M ...	Glumetinib	18 Years - 80 Years	Haihe Biopharma Co., Ltd.
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer	NCT04270591	C-Met Exon 14 M...	Glumetinib	18 Years - 80 Years	Haihe Biopharma Co., Ltd.
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer	NCT04270591	C-Met Exon 14 M...	Glumetinib	18 Years - 80 Years	Haihe Biopharma Co., Ltd.

Spots Global Cancer Trial Database for glumetinib

Every month we try and update this database with for glumetinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for glumetinib

Every month we try and update this database with for glumetinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for glumetinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.