Clinical trial NCT06709859: Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Conversion Therapy
Afatinib
Lead sponsor: Shandong Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2024-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: The rate of NSCLC converting to resectable tumors
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: R0 resection rate
timeFrame: immediately after the surgery
measure: Major pathologic response (MPR) Rate
timeFrame: Up to 12 weeks
measure: Pathologic complete response (pCR) Rate
timeFrame: Up to 12 weeks
measure: Tumor downstaging rate
timeFrame: Up to 12 weeks
measure: Objective response rate (ORR)
timeFrame: Up to five years
measure: Disease control rate (DCR)
timeFrame: Up to five years
measure: Event-free survival (EFS)
timeFrame: Up to five years
measure: The 2-year progression-free survival (PFS) rate
timeFrame: Up to two years
measure: Overall Survival (OS)
timeFrame: Up to five years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
Study officials:
affiliation: Shandong Public Health Clinical Center
name: Hua Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: