Clinical trial · Interventional
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
NCT06890182CI-TRIAL-00087553not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed
- description
- furmonertinib 80mg/d for 12 weeks and carboplatin AUC5 d1 iv / cisplatin 75mg/m2 d1 iv+ pemetrexed 500mg/m2 d1 iv at 21 day cycles for 4 cycles
- interventionNames
- Drug: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed
Primary outcomes (1)
- measure
- Major pathological response rate (MPR)
- timeFrame
- Approximately 24 weeks following the first dose of study drug
- description
- Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
Secondary outcomes (5)
- measure
- Pathological Complete Response Rate(pCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provide informed consent prior to any study specific procedures 2. at least 18 years of age 3. Histology or cytology diagnose of non-small cell lung cancer within 60 days 4. ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks 5. Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging), 6. According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm) 7. EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations) 8. Without prior anti-tumor treatment 9. Withe adequate organ function of hematology, liver and kidney 10. 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 Exclusion Criteria: 1. Dual or multiple primary NSCLC 2. Any prior anti-tumor treatment 3. With history of other malignancy except for radical resected tumors without recurrence for 5 years or more 4. 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 5. 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 6. Laboratory tests indicate insufficient bone marrow reserve or organ reserve 7. Women with pregnancy or breastfeeding 8. Patients with known or suspected drug allergies, or other contraindications 9. Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate 10. Patients who are currently or previously enrolled in any other anti-tumor clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.