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Small Molecule Inhibitor
Glumetinib for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Haihe Biopharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with stage IIIb or IIIc NSCLC who are not candidates for definitive surgical resection or concurrent chemoradiation or patients with stage IV NSCLC (AJCC version 8)
Adequate bone marrow reserve, renal and liver function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is for patients with an advanced lung cancer that has a positive c-MET gene. There will be approximately 90 patients in the first phase in China and 78 evaluable patients in the second phase globally. There will be an additional 6 patients in the second phase in the US.
Who is the study for?
Adults with advanced c-MET-positive Non-Small Cell Lung Cancer who can't have or don't want chemotherapy, or those who've tried up to two treatments without success. They must have at least one measurable tumor and good organ function. Pregnant individuals, those not using contraception, and patients with certain heart conditions or other cancers are excluded.Check my eligibility
What is being tested?
The trial is testing Glumetinib's effectiveness and safety in treating lung cancer that tests positive for a specific mutation (c-MET). It includes about 90 people in China for Phase Ib and around 78 globally for Phase II, plus a safety run-in group in the US.See study design
What are the potential side effects?
While the specific side effects of Glumetinib aren't listed here, common ones may include nausea, fatigue, liver issues like increased enzymes indicating damage or inflammation, diarrhea, rash or skin problems. Serious side effects could involve lung issues like pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have advanced stage lung cancer and are not able to have surgery or receive certain types of treatment.
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Your bone marrow, kidneys, and liver are working well.
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You have already tried one or two different treatments for advanced lung cancer, or you don't want to try chemotherapy even after learning about it.
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You have tried a treatment for your condition, but it did not work or you could not tolerate it.
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If you had treatment to maintain your condition after the first round of chemotherapy, it will be considered as part of the first round if it helped you.
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If you had treatment before to prevent the cancer from coming back and the cancer came back within a year after that treatment, it will be considered as one previous treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR
Secondary outcome measures
DOR
Efficacy of glumetinib
ORR(assessed as per investigators)
Trial Design
1Treatment groups
Experimental Treatment
Group I: SCC244 300mgExperimental Treatment1 Intervention
Phase Ib: SCC244 300mg, QD Phase II: SCC244 300mg, QD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glumetinib
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Haihe Biopharma Co., Ltd.Lead Sponsor
16 Previous Clinical Trials
1,613 Total Patients Enrolled
James Zhou, MDStudy DirectorHaihe Biopharma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have already tried one or two different treatments for advanced lung cancer, or you don't want to try chemotherapy even after learning about it.You have tried a treatment for your condition, but it did not work or you could not tolerate it.You have at least one spot that can be measured and has shown growth since any previous radiation treatment.You have specific mutations in your EGFR, ALK, ROS1, BRAF, or NTRK genes and there are approved treatments available for them.You have a serious heart condition.You've had cancer treatment within 4 weeks or 5 times the half-life of the treatment's medications before starting the study, and haven't recovered from any side effects.In a Phase II study, if you have a specific METex14 skipping mutation in your tumor or blood samples, you can participate. The central laboratory's results will be used to confirm this mutation, even though it's not necessary for eligibility.You have unstable brain metastases or need to take higher doses of steroids for brain disease.You have previously been treated with a specific type of therapy targeting the MET gene, unless you have a specific mutation and are part of a certain study phase.You have HIV with an AIDS-related infection in the past year, or active hepatitis B or C.You have other serious medical conditions that could affect the study results, such as severe infections, diabetes, heart or lung diseases.You have a history of lung disease or have received treatment for lung problems.You have been diagnosed with non-small cell lung cancer (NSCLC) through a tissue or fluid sample.You have advanced stage lung cancer and are not able to have surgery or receive certain types of treatment.For the Phase Ib study, patients should have specific changes in their MET gene, as confirmed by local or sponsor-approved testing.Your bone marrow, kidneys, and liver are working well.You have had non-lung cancer in the past, except for certain types like skin, breast, cervical, or bladder cancer that have been treated or not spread for at least 5 years.If you had treatment before to prevent the cancer from coming back and the cancer came back within a year after that treatment, it will be considered as one previous treatment.If you had treatment to maintain your condition after the first round of chemotherapy, it will be considered as part of the first round if it helped you.You are able to perform daily activities without any difficulty or with slight limitations.
Research Study Groups:
This trial has the following groups:- Group 1: SCC244 300mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment an innovative undertaking?
"At present, two clinical trials are investigating this particular treatment across 21 cities and 3 countries. The initial trial was commenced by Haihe Biopharma Co., Ltd. in 2019 with 183 patients taking part. Following the successful completion of Phase 1 & 2, one more study has been concluded since then."
Answered by AI
What is the magnitude of this clinical trial's participant base?
"Yes, according to clinicaltrials.gov this research effort is still recruiting members of the public. It was initially posted on July 15th 2019 and has recently been updated as of July 28th 2022. This study aims to enrol 183 people from two different locations."
Answered by AI
Is the age requirement for this experiment flexible beyond 35 years?
"This clinical trial has a minimum age restriction of 18 and an upper limit set at 80 years old."
Answered by AI
Has this approach to therapy been tried before in any other studies?
"Currently, two trials are being conducted to assess the potential of this treatment with none in their final phase. 45 sites from around the world, many based in Guangzhou, Guangdong are participating in clinical studies for this medication."
Answered by AI
Is this research study presently open to new participants?
"Affirmative. Clinicaltrials.gov corroborates that this clinical trial is actively looking for participants, with the original posting on July 15th 2019 and most recent update occurring on July 28th 2022. This research project aims to include 183 patients split between two hospitals."
Answered by AI
Is it feasible for me to participate in this medical experiment?
"To be considered for this medical trial, applicants must possess non-small cell lung carcinoma and fall between the ages of 18 and 80. Currently, 183 individuals are in process or have been admitted to the program."
Answered by AI
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