A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Afatinib plus chemotherapy as conversion treatment
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Shandong Public Health Clinical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The rate of NSCLC converting to resectable tumors
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Afatinib plus chemotherapy
Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery.
Intervention: Afatinib plus chemotherapy as conversion treatment
Outcomes
Primary Outcomes
The rate of NSCLC converting to resectable tumors
Time Frame: 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 Outcomes
- R0 resection rate(immediately after the surgery)
- Major pathologic response (MPR) Rate(Up to 12 weeks)
- Pathologic complete response (pCR) Rate(Up to 12 weeks)
- Tumor downstaging rate(Up to 12 weeks)
- Objective response rate (ORR)(Up to five years)
- Disease control rate (DCR)(Up to five years)
- Event-free survival (EFS)(Up to five years)
- The 2-year progression-free survival (PFS) rate(Up to two years)
- Overall Survival (OS)(Up to five years)