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New treatment option for NSCLC (Non-small Cell Lung Carcinoma)
Official title Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcinoma
ClinicalTrials.gov ID: NCT07314216
What this study is testing
What is Firmonertinib?
Firmonertinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nsclc (non-small cell lung carcinoma).
Also referred to as AST2818.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. The primary endpoint is Progression-Free Survival (PFS), assessed by the investigator according to RECIST 1.1 criteria, defined as the time from the first dose to objective disease progression or death (from any cause).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of informed consent prior to any study-specific procedures;
- Age ≥18years;
- ECOG performance status of 0 or 1 with no deterioration within the 2 weeks prior to enrollment, and a life expectancy of ≥12 weeks;
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer;
- Assessed as having unresectable or inoperable locally advanced non-squamous non-small cell lung cancer suitable for definitive radiotherapy (Stage...
You likely can't join if
- Pathological type is pulmonary squamous cell carcinoma or small cell lung cancer;
- Known history of hypersensitivity to the active or inactive excipients of firmonertinib, or to drugs with a similar chemical structure or class to...
- Confirmed presence of EGFR exon 19 deletion or exon 21 L858R mutation;
- Presence of metastatic disease, or assessed as unsuitable for definitive radiotherapy; or unable to undergo definitive radiotherapy due to extensive...
- NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumor;
- Prior to the first dose of the study drug, patients who have received any of the following treatments;
See the full eligibility criteria
Who can join
- Provision of informed consent prior to any study-specific procedures;
- Age ≥18years;
- ECOG performance status of 0 or 1 with no deterioration within the 2 weeks prior to enrollment, and a life expectancy of ≥12 weeks;
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer;
- Assessed as having unresectable or inoperable locally advanced non-squamous non-small cell lung cancer suitable for definitive radiotherapy (Stage III according to AJCC 9th edition TNM staging);
- Presence of EGFR uncommon mutations (excluding 19del, L858R, T790M) confirmed by genetic testing in a tertiary grade A hospital; specific types are detailed in Appendix 11;
- No prior systemic anti-tumor therapy or radiotherapy for locally advanced non-small cell lung cancer before the first dose of the study drug, including chemotherapy, biologic therapy, targeted therapy, immunotherapy, or...
- At least one accurately measurable lesion according to RECIST 1.1, which has not been previously irradiated and was not biopsied during the screening period. If a subject has only one measurable lesion, biopsy of that...
- Female people must use highly effective contraception (see restrictions) for at least 2 weeks prior to the first dose, have a negative pregnancy test, must not be breastfeeding at the time of treatment initiation, OR...
- Postmenopausal, defined as age over 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal treatments;
- For women aged 50 years or younger, amenorrhea for 12 months or more after cessation of exogenous hormone therapy and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the institutional...
- Irreversible surgical sterilization documented by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but excluding tubal ligation;
- Male people must be willing to use barrier contraception ;
- Ability to comply with the study protocol and follow-up procedures, and capable of oral medication intake
What rules you out
- Pathological type is pulmonary squamous cell carcinoma or small cell lung cancer;
- Known history of hypersensitivity to the active or inactive excipients of firmonertinib, or to drugs with a similar chemical structure or class to the investigational drug;
- Confirmed presence of EGFR exon 19 deletion or exon 21 L858R mutation;
- Presence of metastatic disease, or assessed as unsuitable for definitive radiotherapy; or unable to undergo definitive radiotherapy due to extensive tumor volume resulting in normal tissue radiation doses exceeding dose...
- NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumor;
- Prior to the first dose of the study drug, patients who have received any of the following treatments;
- Any prior EGFR-TKI therapy;
- Patients who have received intrapleural infusion therapy; these patients may be enrolled only after pleural effusion has been stable for 28 days or more;
- Major surgery within 28 days prior to the first dose of study drug (In China, major surgery is defined according to the Level 3 and Level 4 surgeries specified in the "Administrative Measures for the Clinical...
- Treatment with strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose, or patients who require continued use of these drugs during the study period (see Appendix 6 for drug list);
- Treatment with traditional Chinese medicine or Chinese patent medicine for anti-tumor indications within 7 days prior to the first dose, or patients who require continued use of these drugs during the study period;
- Concurrent use of medications known to prolong the QTc interval or that may induce Torsade de Pointes, and which require continued administration during the study period (see Appendix 8 for drug list);
- Discontinuation of other investigational drugs within less than 5 half-lives or 2 months (whichever is longer) prior to the first dose;
- Toxicities from prior anti-tumor therapy have not recovered to ≤ CTCAE Grade 1 prior to the first dose of the study drug (except for alopecia or chemotherapy-induced peripheral neuropathy ≤ CTCAE Grade 2);
- Patients with unstable pleural effusion;
- History of, or diagnosis with, another malignancy within the past 5 years, except for effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast;
- Recent active digestive tract diseases, such as duodenal ulcer, ulcerative colitis, ileitis, etc.; intestinal perforation; intestinal fistula; or other conditions deemed by the investigator as potentially leading to...
- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, active bleeding, etc., which in the investigator's judgment is not conducive to the patient's participation in the...
- History of interstitial lung disease (ILD), drug-induced ILD, prior history of radiation pneumonitis requiring steroid treatment, or any evidence of active ILD;
- Any known evidence of corneal lesions/damage;
- Inadequate bone marrow reserve or organ function based on examinations within 28 days prior to the first dose of study drug (without transfusion or blood products, granulocyte colony-stimulating factor, or other...
- Absolute neutrophil count \<1.5 × 10\^9/L; Platelet count \<100 × 10\^9/L; Hemoglobin \<90 g/L;
- Alanine aminotransferase \> 2.5 × ULN; Aspartate aminotransferase \>2.5 × ULN; Total bilirubin \> 1.5 × ULN, or for patients with liver metastases, AST and/or ALT \>5 × ULN;
- Serum creatinine \>1.5 × ULN, OR Creatinine clearance \<50 mL/min (measured or calculated using the Cockcroft and Gault formula, see Appendix 2);
- International Normalized Ratio \> 1.5, AND Activated Partial Thromboplastin Time \>1.5 × ULN;
- Any of the following cardiac criteria;
- Mean resting corrected QT interval (QTc) \>470 msec obtained from 3 consecutive ECGs, calculated using Fridericia's formula;
- Any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG within 28 days prior to the first dose, e.g., complete left bundle branch block, third-degree, and second-degree heart block;
- Cardiac function assessment within 28 days prior to the first dose: Left Ventricular Ejection Fraction \<50%; history of myocardial infarction, severe/unstable angina, or coronary artery bypass graft surgery within the...
- Pregnancy or lactation;
- Patients judged by the investigator as ineligible for the study, such as those unlikely to comply with the study protocol, procedures, and requirements; or any other circumstances warranting exclusion based on the...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.