Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib (NCT03976856) | Clinical Trial Compass
UnknownPhase 1
Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib
China42 participantsStarted 2019-07-23
Plain-language summary
This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18-75 years, male or female;
. Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form;
. Histologically or cytology confirmed relapsed or metastatic NSCLC;
. EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). Moreover, the following conditions are met:
. No T790M mutation after failure of EGFR-TKI treatment;
. T790M mutation after EGFR-TKI treatment failure, and failed to respond to third-generation EGFR-TKI treatment; primary T790M mutation, progressed after third-generation EGFR-TKI treatment or no other available effective therapies;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Event
Timeframe: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.
2
Incidence of Serious Adverse Event
Timeframe: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.
. The above patients failed to respond to chemotherapy or are unwilling to or intolerable to chemotherapy;
. According to the RECIST 1.1 criteria, at least one target lesion (the lesion with a longest diameter ≥10 mm, or a lymph node with a short diameter ≥15 mm) are measured by CT or MRI;
Exclusion criteria
. Patients with lung squamous cell carcinoma (including adenosquamous carcinoma);
. ALK fusion gene rearrangement confirmed by genetic testing;
. Patients with history of other malignant tumors (except cured cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma) may not participate in the study unless the diseases have been cured for at least 5 years prior to enrollment, and it is estimated that no other treatment will be required throughout the study;
. Detection of the tumor lesion ≤ 5 mm from the large vessel, or a central tumor that invaded the local large vessel; or a significant pulmonary cavity or necrotizing tumor by imaging (CT or MRI);
. Active central nervous system (CNS) metastasis, including symptomatic brain metastasis, meningeal metastasis or spinal cord compression; patients with asymptomatic brain metastases can be enrolled (no progression and/or neurological symptoms or signs after surgical resection within at least 4 weeks after radiotherapy, no history of treatment with glucocorticoids, anticonvulsants or mannitol);
. Symptomatic, uncontrollable serous effusions such as ascites, pleural effusion, or pericardial effusion;
. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity;
. Patients with thrombolytic therapy or therapeutic anticoagulant drugs (except prophylactic anticoagulant drugs) within 10 days before the first study drug;