Chemotherapy, EGFR, Locally Advanced Non-Small Cell Lung Cancer, NSCLC (Non-small Cell Lung Cancer), Radiotherapy
Conditions
Keywords
Chemotherapy, EGFR, NSCLC (non-small cell lung cancer), radiotherapy, Locally Advanced Non-Small Cell Lung Cancer
Brief summary
The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.
Interventions
DRUGFumetinib combined platinum-based double chemotherapy
Fumetinib combined platinum-based double chemotherapy
COMBINATION_PRODUCTConcurrent Radiochemotherapy
Concurrent Radiochemotherapy
Sponsors
Peng Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; * Minimum age: 18 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathologic response (MPR) | up to 4 months | 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 |
Countries
China
Contacts
CONTACTPeng Zhang
CONTACTYue Liu
Outcome results
None listed