Clinical trial NCT05514314: A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection
Official title: A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least ≥ 18 years，and ≦ 80 years
* Lung adenocarcinoma.
* Stage I disease(IA or IB), based on TNM8 classification.
* There is at least one of the following high-risk factors:

  1. pathologically confirmed vascular invasion positive;
  2. pathologically confirmed lung adenocarcinoma containing solid or micropapillary or complex gland histology, with a percentage \> 20%;
  3. pathologically confirmed invasive tumor size \> 2 cm;
  4. pathologically confirmed visceral pleural involvement (T2a).
* Started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy.
* A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) ,without KRAS mutation
* World Health Organization performance status of 0 or 1.
* Bood routine: HB \> 80g/L; ANC \> 1.0x109/L; PLT \> 50x109/L.Blood biochemistry： ALT and AST \< 2.5 times the upper limit of normal; Crea \< 1.5 times the upper limit of normal.
* Good adherence to follow-up.
* During the trial and for 3 months after the trial，Participants must be using highly effective contraceptive measures.

Exclusion Criteria:

* Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
* Local radiotherapy.
* Patients with cancers other than NSCLC (except cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors) within 5 years prior to the start of treatment in this study.
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, severe arrhythmia requiring medication, liver, kidney or metabolic disease).
* Any clinical evidence suggestive of active interstitial lung disease.
* An eye inflammation or eye infection that is not fully controlled, or any condition that could lead to one of these eye conditions.
* Known human immunodeficiency virus (HIV) infection.
* Known hypersensitivity to EGFR-TKI drugs or related components.
* Mixed small cell and non-small cell cancer history.
* Substance abuse, or illnesses such as psychological or psychiatric disorders that may interfere with study compliance.
* Patients with epilepsy requiring medication (e.g. steroids or anti-epileptic drugs).
* Other conditions deemed unsuitable for enrollment by the investigator.

Primary outcomes:
measure: Recurrence-Free Survival (RFS)
timeFrame: Up to approximately 10 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 10 years
measure: Safety and tolerability
timeFrame: Up to approximately 10 years
Other outcomes:
Locations:
Study officials:
References: