Furmonertinib for Advanced Non-Small Cell Lung Cancer
High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib
Recruiting
Phase 2Interventional Study
Non-Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Changhai Hospital · Other
Who this trial is looking for
This trial is looking for people with advanced lung cancer who have not responded to earlier treatments with Osimertinib. Participants will take Furmonertinib daily and be monitored for their health and response to the drug.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with metastatic lung adenocarcinoma
I have had imaging-confirmed disease progression after Osimertinib
I have had previous genetic testing confirming an EGFR-sensitive mutation or a T790M mutation
I experienced clinical benefit from Osimertinib treatment
I have at least one measurable tumor as per RECIST criteria
My major organs are functioning normally
I am a pre-menopausal woman with a negative pregnancy test
I have voluntarily signed the consent form
You may not be able to join if
I have received chemotherapy or immunotherapy before
I have a different type of lung cancer, like squamous lung cancer
I have progression after Osimertinib and have other treatment options
I have symptomatic brain metastases or spinal cord compression
I have unresolved serious side effects from prior Osimertinib treatment
I have had other cancers within the last 5 years
I have a history of interstitial pneumonia
The investigator thinks I am not suitable for this study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until …
This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed metastatic lung adenocarcinoma
* Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
* Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extra…
Inclusion Criteria:
* Histologically or cytologically confirmed metastatic lung adenocarcinoma
* Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
* Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
* Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration \>6 months);
* Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
* Normal functioning of major organs
* Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
* Subjects volunteered and signed a written informed consent form.
Exclusion Criteria:
* Previous chemotherapy or immunotherapy
* Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
* Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
* Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
* Any unrecovered CTCAE \> grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
* Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
* History of interstitial pneumonia with previous diagnosis
* Other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study
Contacts
No contact information available.
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
