Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

Phase 2RecruitingNCT06755684

Peng Zhang60 enrolled

Overview

This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

EGFR Non-Small Cell Lung Cancer Locally Advanced Non-Small Cell Lung Cancer Pemetrexed Carboplatin Bevacizumab Antineoplastic Agents

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy; * At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS; * No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.); * With the feasibility to receive radical surgery ; * Good lung function that could tolerate surgical treatment; * Aged 18-75 years; * At least one measurable tumor foci (the longest diameter measured by CT shall be \> 10 mm); * Other major organs shall function well (liver, kidney, blood system, etc.): * ECOG PS score shall be 0-1; * The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial; * The patient shall sign the Informed Consent Form. Exclusion Criteria: * The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.; * The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ Grade II specified by New York Heart Association (NYHA)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment; * The patient is a carrier of HIV; * The patient has had or is currently suffering from interstitial lung disease; * The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial; * The patient is allergic to befotertinib or its any excipients; * The patient is allergic to bevacizumab or its any excipients; * The patient is allergic to platinum-based double chemotherapy or its any excipients; * The female patient is in pregnancy or lactation period; * There are any conditions under which the investigator considers the patient is not suitable to be enrolled.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts