A Phase 2 interventional study of Befotertinib combined Bevacizumab and Befotertinib combined platinum-based double chemotherapy in EGFR, Non-Small Cell Lung Cancer and Locally Advanced Non-Small Cell Lung Cancer, sponsored by Peng Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Peng Zhang · Phase 2, Interventional, and Treatment
This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation
Exclusion Criteria:
Befotertinib combined Bevacizumab
Drug: Befotertinib combined Bevacizumab
Befotertinib combined platinum-based double chemotherapy
Drug: Befotertinib combined platinum-based double chemotherapy
Befotertinib combined Bevacizumab
Befotertinib combined platinum-based double chemotherapy
Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Time frame: up to 4 months
Objective response rate (ORR)
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
Time frame: Up to 4 months
Progression-free survival (PFS)
It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Time frame: up to 60 months
Event-free survival (EFS)
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to 60 months
Disease-free survival (DFS)
It refers to the time (months) from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).
Time frame: up to 60 months
Overall survival (OS)
It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Time frame: up to 60 months
R0 rate
It is defined as the rate of complete resection with no residual tumor cell in the resection margin.
Time frame: up to 4 months
adverse event (AE) rate
It is defined as the frequency of adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Time frame: up to 4 months
Complete Pathological response (CPR)
CPR is defined as the proportion of participants who have achieved complete pathologic response (on routine hematoxylin and eosin staining, tumors with no viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Time frame: Up to 4 months
Plan to share: Undecided
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Peng Zhang