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NCT05132985 | Not yet recruiting | NSCLC

Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma
Sponsor:

Liaoning Tumor Hospital & Institute

Information provided by (Responsible Party):

hongneedlIU

Brief Summary:

Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.

Condition or disease

NSCLC

EGF-R Positive Non-Small Cell Lung Cancer

Intervention/treatment

Icotinib

Cisplatin

Carboplatin

Pemetrexed

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 45 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : January 1, 2028
Arm Intervention/treatment

Experimental: Icotinib+chemotherapy

Neoadjuvant chemotherapy (pemetrexed + carboplatin/cisplatin ) will start within 1-3 days from enrollment at 21-day (+/-3 days) intervals (Q3W) prior to surgery. Before surgery a tumor assessment will be done to exclude evidence of progression. Patients with radiographically stable disease or partial response may be considered for operation. Icotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of Icotinib is 125mg 1tt(Take 1 tablet 3 times a day) orally. Surgery: Surgery must be done within the 3rd to 4th week (+7 days) from day 21 cycle 2 of neoadjuvant treatment. Adjuvant treatment: Patients receive additional 2 cycles of platinum-based doublet chemotherapy(Researcher decide) on day 1 with intercalated icotinib (D8-15) every 3 weeks, and continued icotinib for 2 years or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity

Drug: Icotinib

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Key Inclusion Criteria
  • Written informed consent
  • Male or female, aged ≥18 years and ≤75 years
  • Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology)
  • Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation
  • A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone
  • ECOG PS 0/1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
  • Adequate organ and marrow function as defined by
    • Hemoglobin: ≥9.0 g/dL
    • Absolute neutrophil count: ≥1.5 × 109/l
    • Platelet count: ≥100 × 109/l
    • Serum bilirubin: ≤1.5 ULN
    • ALT and AST: ≤2.5 × ULN
    • Creatinine clearance: ≥60 ml/min
    • Life expectancy of 6 months prior to randomization
    Exclusion Criteria
    • Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy
    • EGFR-TKI-sensitizing mutations with T790M
    • Mixed small cell and non-small-cell lung cancer histology
    • T4 tumors infiltrating the aorta, esophagus and/or heart
    • Bulky N2 disease
    • Candidates for segmentectomies or wedge resections only
    • Medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD
    • Severe or uncontrolled systemic diseases/active infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy
Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

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Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

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Locations

Not yet recruiting

China, Liaoning

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China, 110000