A Phase 2 interventional study of Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed in Non-small Cell Lung Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
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.
In this open-label, single-arm, phase 2 study, 31 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive firmonertinib for 12 weeks combined with carboplatin/cisplatin and pemetrexed for 4 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's planned enrollment of 31 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed
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
Major pathological response rate (MPR)
Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
Time frame: Approximately 24 weeks following the first dose of study drug
Pathological Complete Response Rate（pCR)
The proportion of patients with pathological response rate in the resected tumor.
Time frame: Approximately 24 weeks following the first dose of study drug
Objective Response Rate (ORR)
According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy CT scans scans assessed the proportion of patients in partial and complete remission.
Time frame: Approximately 8 weeks following the first dose of study drug
Rate of R0 Resection
The proportion of patients with R0 resection.
Time frame: Approximately 16 weeks following the first dose of study drug
Pathological downstaging of lymph node rate
The proportion of patients with pathological downstaging of lymph node rate
Time frame: Approximately 16 weeks following the first dose of study drug
Incidence of adverse events (AE)
The number of patients with adverse events and the severity according to CTCAE v5.0
Time frame: Approximately 12 weeks following the first dose of study drug
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Tianjin Medical University Cancer Institute and Hospital