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Intercalated Combination of Icotinib and Chemotherapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

A Randomised, Controlled, Multicenter Study to Comparing the Effect of Icotinib plus Intercalated Chemotherapy Combination therapy with Icotinib Alone Therapy as First-line Treatment for Patients with Non-Small-Cell Lung Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004971
Enrollment
Unknown
Registered
2014-07-15
Start date
2014-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Non-Small-Cell Lung Cancer

Interventions

Icotinib combination chemotherapy group:Chemotherapy (on day 1 of each 3 week cycle) in combination with Icotinib (125 mg po three times a day on days 2-15 of each 3 week cycle) for 4 cycles
then continue to receive Icotinib 125 mg po three times a day daily until progression
Icotinib alone threapy group:Receive Icotinib 125 mg po three times a day daily until progression

Sponsors

Shandong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 2. Adult patients, older than 18 years of age; 3. Advanced (stage IIIB/IV) non-small-cell lung cancer; 4. Although stage I-IIIA, have contraindications to surgery; 5. ECOG Performance Status 0 or 1 or 2 or 3; 6. All subjects or their guardians must sign an informed consent before entering the trial.

Exclusion criteria

Exclusion criteria: 1. Wild-type EGFR; 2. Are allergic to Icotinib, pemetrexed, docetaxel or carboplatin or with intolerance; 3. Prior chemotherapy or systemic anti-tumor therapy after advanced disease; 4. Unstable systemic disease; 5. Brain metastasis.

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS);

Secondary

MeasureTime frame
Objective response rate (ORR);Disease control rate (DCR);Overall survival (OS);

Countries

China

Contacts

Public ContactLi Yu
qlliyu@163.com+86 13791122770

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026