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Adjuvant Chemotherapy With or Without Intercalated Icotinib

Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients With or Without Intercalated Icotinib Therapy: a Randomized, Placebo-controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03983811
Enrollment
174
Registered
2019-06-12
Start date
2019-07-01
Completion date
2025-10-31
Last updated
2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief summary

Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study aims to assess the efficacy and safety of adjuvant chemotherapy with or without Intercalated combination of icotinib in patients undergoing resection of stage IIB to IIIA (N1-2) EGFR-mutated NSCLC.

Interventions

DRUGIcotinib

Patients receive 4 cycles of platinum-based doublet chemotherapy 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

DRUGPlacebo

Patients receive 4 cycles of platinum-based doublet chemotherapy on day 1 with intercalated placebo (D8-15) every 3 weeks, and continued placebo for 2 years or until the occurrence of disease relapse, metastasis or unacceptable toxicity

OTHERchemotherapy

Patients in each groups need to receive 4 cycles of platinum-based doublet chemotherapy

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing completely resection of EGRF mutation-positive NSCLC Staging IIB to ⅢA, N1-2; PS = 0 or 1; Adequate hematological, biochemical and organ functions

Exclusion criteria

* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating

Design outcomes

Primary

MeasureTime frameDescription
Disease free survivalFrom the date of surgery until the date of first confirmed disease relapse or metastasis, whichever came first, assessed up to 5 yearsThe amount of time that patient lives without known recurrence

Secondary

MeasureTime frame
Number of Participants with Adverse EffectsDuration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026