Firmonertinib, Anlotinib and Chemotherapy Before Surgery for EGFR-Mutated Lung Cancer
Tests firmonertinib, anlotinib and chemotherapy before surgery in adults with EGFR-mutated lung cancer.
Key facts
- Who runs it
- Hubei Cancer Hospital
- Where
- Wuhan, ChinaSee the site
- Trial code
- Registry title
- Neoadjuvant Therapy With Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy for Resectable EGFR-Mutated NSCLC
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 29 people, planned
- Started
- 21 Sept 2026
- Expected to end
- Sept 2030
- Type of study
- Interventional
- Treatments tested
- Firmonertinib combined anlotinib and chemotehrapy
- Record updated
- 8 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with EGFR-mutant lung cancer (non-small cell) that can be removed by surgery and has not spread to other parts of the body.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer with an EGFR mutation (19Del or 21L858R), confirmed by biopsy. Stage IIA-IIIB, can be removed by surgery, no spread to other organs. At least one tumor of 10mm or more on CT.
- Earlier treatment
- No earlier treatment for this lung cancer, such as surgery, radiotherapy, chemotherapy or targeted drugs.
- Biomarker or test result
- EGFR mutation positive (19Del or 21L858R).
Main reasons for not taking part
- Another cancer in the last 5 years (a few exceptions)
- Active hepatitis B, hepatitis C or HIV
- Interstitial lung disease, now or in the past
- Unstable heart or other serious body illness
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- EGFR mutation positive non-small cell lung cancer (including 19Del and 21L858R) confirmed by biopsy
- Resectable stage IIA-IIIB (8th edition TNM staging) non-small cell lung cancer diagnosed by chest CT, PET-CT, or/and EBUS
- No systemic metastasis (head MRI, whole-body bone scan PET-CT、 Liver and adrenal CT scans, etc
- Good lung function, able to tolerate surgical treatment
- Age 18 and above
- At least one measurable tumor lesion (with a maximum diameter of 10mm or more as measured by CT)
- Other major organs (liver, kidney, blood system, etc.) are functioning normally:; 1)Hemoglobin ≥ 9.0 g/dL (or can be maintained through blood transfusion or exceed this standard) 2)Red blood cell count ≥ 2.0 × 10\^9/L 3)Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L 4)Platelet count ≥ 100 × 10\^9/L 5)Total bilirubin is within the normal range 6)Alanine transaminase, aspartate transaminase, and alkaline phosphatase ≤ 2.5 times the upper limit of normal values 7)Creatinine ≤ 2.0 mg/dL; Creatinine clearance rate ≥ 60ml/min 8)The international normalized ratio (INR) of prothrombin time to activated partial thromboplastin time for patients who have not received anticoagulant therapy is ≤ 1.5 times the upper limit of normal. Patients who have received comprehensive or intravenous anticoagulant therapy can only participate in clinical trials if the dosage of anticoagulant drugs is stable for more than 2 weeks and the coagulation test results are within the local treatment range
- ECOG PS score is 0-1 9. Women of childbearing age must undergo a pregnancy test within 7 days before treatment, and the result is negative. During the trial period and within 30 days after the end of the trial, reliable contraceptive measures such as intrauterine devices, birth control pills, condoms, etc. should be taken. During the trial period and within 30 days after the end of the trial, men of childbearing age should use condoms for contraception; 10. Patients should sign an informed consent form
Who cannot take part
- The patient has received systemic anti-cancer treatment for non-small cell lung cancer, including surgical treatment, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, etc
- Patients with other cancers (excluding cervical cancer in situ, cured basal cell carcinoma, and bladder epithelial tumors [including Ta and Tis]) within the 5 years prior to the trial, unless they have small cell lung cancer
- The patient has any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina that has started to occur in the past 3 months, congestive heart failure [≥ NYHA Grade II], myocardial infarction (6 months prior to enrollment), severe arrhythmia, and liver, kidney, or metabolic diseases that require medication treatment)
- The patient is receiving treatment with P-glycoprotein inhibitors
- Individuals who have previously suffered or are currently suffering from cardiovascular malformations
- The patient has previously suffered from or is currently suffering from interstitial lung disease
- The patient has undergone other major systemic surgeries or suffered severe trauma within the 3 months prior to the trial
- The patient is an active hepatitis B, hepatitis C or HIV carrier
- Severe or newly diagnosed gastrointestinal disease patients with diarrhea as the main symptom
- Suffering from neurological or psychiatric disorders
- The patient has malabsorption
- Female patients in pregnancy or lactation period
- Other researchers believe that patients are not suitable for inclusion in the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in China
- Hubei Cancer HospitalWuhan, ChinaContact: Sheng WangNo longer taking part
About the trial
What the trial wants to find out
Exploring the efficacy and safety of firmonertinib combined with anlotinib and platinum-based doublet chemotherapy as neoadjuvant therapy in patients with EGFR-mutant resectable NSCLC
The group in the trial
- Experimental GroupTreatment being tested
Firmonertinib combined with anlotinib and chemotherapy
Treatment: Firmonertinib combined anlotinib and chemotehrapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy in Patients With EGFR-mutant Resectable NSCLC : A Prospective, Multicenter, Single Arm, Phase II Exploratory Clinical Study
- Plain-language title
- Firmonertinib, Anlotinib and Chemotherapy Before Surgery for EGFR-Mutated Lung CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07807722, who can take part
- Record updated
- 8 September 2026