Surgery Clinical Trial - Neoadjuvant Afatinib Combination With

Status Not yet recruiting

Clinical Trial Summary

The recommended adjuvant therapy for stage Ⅱa-Ⅲb Non-small cell lung cancer (NSCLC) were perioperative chemotherapy. The adjuvant or neoadjuvant chemotherapy for early stage lung cancer improved about 5% 5-year survival. As for advanced NSCLC with epidermal growth factor receptor (EGFR) activating mutation, epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) combination with chemotherapy had improved progression-free survival (PFS) compared with EGFR-TKI alone. We propose this trial of Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation, which would maximize benefit early in a patient's treatment course. At the same time, dynamic 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography (18F-FDG PET) was used to evaluate the standardized uptake value (SUV) and uptake rate constant (Ki) changes of lesions before and after treatment, so as to accurately and quantitatively monitor the tumor response of different therapy.

Clinical Trial Description

The prognosis of stage Ⅱa-Ⅲb Non-small cell lung cancer (NSCLC) was worse, with 5-year survival rate between 26%-60%. The recommended adjuvant therapy for stage Ⅱa-Ⅲb NSCLC were adjuvant or neoadjuvant chemotherapy. As for advanced NSCLC with EGFR activating mutation, EGFR-TKI combination with chemotherapy had improved survival compared with EGFR-TKI alone. The Chinese Thoracic Oncology Group-1103 (CTONG-1103) trial showed that neoadjuvant erlotinib has better PFS than neoadjuvant chemotherapy.

The investigators propose that neoadjuvant EGFR-TKI combination with chemotherapy for stage Ⅱa-Ⅲb NSCLC with EGFR activating mutation might have better pathological response and disease-free survival (DFS) than chemotherapy alone, and maximize benefit early in a patient's treatment course. At the same time, dynamic 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography (18F-FDG PET) was used to evaluate the standardized uptake value (SUV) and uptake rate constant (Ki) changes of lesions before and after treatment, so as to accurately and quantitatively monitor the tumor response of different therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04470076
Study type	Interventional
Source	Fifth Affiliated Hospital, Sun Yat-Sen University
Contact	QingDong Cao, MD
Phone	+8607562528824
Email	cqd8866@163.com
Status	Not yet recruiting
Phase	Phase 2
Start date	July 10, 2020
Completion date	July 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05583916` - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery	N/A
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed	`NCT03213314` - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies	N/A
Enrolling by invitation	`NCT05534490` - Surgery and Functionality in Older Adults	N/A
Recruiting	`NCT04792983` - Cognition and the Immunology of Postoperative Outcomes
Terminated	`NCT04612491` - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting	`NCT06397287` - PROM Project Urology
Recruiting	`NCT04444544` - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed	`NCT04204785` - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions	N/A
Completed	`NCT03432429` - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed	`NCT04176822` - Designing Animated Movie for Preoperative Period	N/A
Recruiting	`NCT05370404` - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:	N/A
Not yet recruiting	`NCT05467319` - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS	Phase 3
Recruiting	`NCT04602429` - Children's Acute Surgical Abdomen Programme
Completed	`NCT03124901` - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor	N/A
Completed	`NCT04595695` - The Effect of Clear Masks in Improving Patient Relationships	N/A
Recruiting	`NCT06103136` - Maestro 1.0 Post-Market Registry
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Completed	`NCT04059328` - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting	`NCT03697278` - Monitoring Postoperative Patient-controlled Analgesia (PCA)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation — Neoafa

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms