Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Conversion Therapy, Afatinib
Brief summary
This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
Detailed description
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer. The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).
Interventions
DRUGAfatinib plus chemotherapy as conversion treatment
Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.
Sponsors
Shandong Public Health Clinical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator. * Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation * ECOG Performance Status of 0-1 * At least one measurable lesion according to RECIST 1.1 * Adequate organ and marrow function
Exclusion criteria
* Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma * The presence of malignant pleural effusion * Prior systemic anti-cancer therapy for non-small cell lung cancer * Prior local radiotherapy for NSCLC * Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of NSCLC converting to resectable tumors | Up to 12 weeks | The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response (pCR) Rate | Up to 12 weeks | The proportion of patients who achieve pCR among those receiving surgery |
| Tumor downstaging rate | Up to 12 weeks | The proportion of patients who reach the successful downstaging criteria for NSCLC |
| Objective response rate (ORR) | Up to five years | The proportion of patients who have a complete response (CR) or partial response (PR). |
| R0 resection rate | immediately after the surgery | The proportion of R0 resection in patients who receive surgery |
| Major pathologic response (MPR) Rate | Up to 12 weeks | The proportion of patients who achieve MRP among those receiving surgery |
| Event-free survival (EFS) | Up to five years | The length of time after initial administration the patient remains free of recurrence/progression or death, whatever the cause. |
| The 2-year progression-free survival (PFS) rate | Up to two years | The proportion of patients who are event-free. |
| Overall Survival (OS) | Up to five years | The length of time after initial administration the patient remains alive |
| Disease control rate (DCR) | Up to five years | The proportion of patients who have a best overall response of CR, PR, or stable disease (SD). |
Countries
China
Contacts
Primary ContactHua Zhang, PhD
Outcome results
None listed