NCT06890182Not yet recruitingPhase 2
Firmonertinib Combined With Chemotherapy as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC
Firmonertinib Combine With Carboplatin/Cisplatin and Pemetrexed as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a phase II study aimed to assess the efficacy and safety of firmonertinib combined with carboplatin/cisplatin and pemetrexed as neoadjuvant therapy in stage II-IIIB resectable NSCLC patients.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 16 Mar 2025
- Start date
- Mar 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06890182
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 31
- From Mar 2025 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior anti-tumor treatment
- Patients who are currently or previously enrolled in any other anti-tumor clinical study.
Other illness
- With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
- With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
- Patients with known or suspected drug allergies, or other contraindications
- Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
Lab values
- Laboratory tests indicate insufficient bone marrow reserve or organ reserve
Other
- Dual or multiple primary NSCLC
- Women with pregnancy or breastfeeding
Who the study is looking for
- Provide informed consent prior to any study specific procedures
- at least 18 years of age
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
- Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging),
- According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- Without prior anti-tumor treatment
- Withe adequate organ function of hematology, liver and kidney
- Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.