Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

NCT01996098 | Terminated Phase 3 DMC

• 2 other identifiers: GASTO1002wsy003
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival

  Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.

  5 years after the last patient is randomized

Secondary Outcomes (3)

• Overall Survival

  5 years after the last patient is randomized

• Number of Participants with Adverse Events

  2 years

• Change from baseline in patient reported Lung Cancer Functional Assessment

  2 years

Study Arms (3)

6-month icotinib

EXPERIMENTAL

Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months

Drug: 6-month Icotinib

12-month icotinib

EXPERIMENTAL

Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months

Drug: 12-month icotinib

Chemotherapy alone

NO INTERVENTION

No intervention

Interventions

6-month Icotinib DRUG

125 mg three times daily (375 mg per day) by mouth for 6 months

Also known as: BPI-2009, Conmana

6-month icotinib

12-month icotinib DRUG

125 mg three times daily (375 mg per day) by mouth for 12 months

Also known as: BPI-2009, Conmana

12-month icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided.
• Aged 18-75 years.
• Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
• EGFR activating mutation in exon 19 or 21.
• Had completed four cycles of platinum-based adjuvant chemotherapy.
• Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy.
• ECOG performance status of 0-1.
• Had a life expectancy of 12 weeks or more.
• Adequate hematological function, adequate liver function and renal function.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

You may not qualify if:

• Had had previous chemotherapy besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
• Any evidence confirmed tumor recurrence before investigational therapy.
• Known severe hypersensitivity to icotinib or any of the excipients of this product.
• Evidence of clinically active interstitial lung disease.
• Eye inflammation not fully controlled or conditions predisposing the subject to this.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Known human immunodeficiency virus (HIV) infection.
• Pregnancy or breast-feeding women.
• Ingredients mixed with small cell lung cancer patients.
• History of neurologic or psychiatric disorders.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

icotinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Si-Yu Wang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: February 15, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

CN (1)