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A Single-arm Study to Evaluate the Efficacy of Intercalated Combination of Chemotherapy and Erlotinib as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

A Single-arm Study to Evaluate the Efficacy of Intercalated Combination of Chemotherapy and Erlotinib as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-14004362
Enrollment
Unknown
Registered
2014-03-08
Start date
2014-04-01
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

experimental group:Erlotinib Hydrochloride Tablets combined with chemotherapy in the treatment of 4 cycles chemotherapy (D1, Erlotinib Hydrochloride Tablets D2-15, stop 5 days. Then next 21 days a cyc

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients,>=18 years of age; 2. Advanced (stage IIIB/IV) non-small-cell lung cancer; 3. Although stage?-?A, have contraindications to surgery; 4. EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 5. Measurable disease; 6. ECOG Performance Status 0 or 1 or 2.

Exclusion criteria

Exclusion criteria: 1. Wild-type EGFR; 2. Prior exposure to agents directed at the HER axis; 3. Prior chemotherapy or systemic anti-tumor therapy after advanced disease; 4. Unstable systemic disease; 5. Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; 6. Brain metastasis or spinal cord compression.

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS);

Secondary

MeasureTime frame
Time to progression;Objective response rate;Overall survival (OS);

Countries

China

Contacts

Public ContactLi Yu

Qilu Hospital of Shandong University

qlliyu@163.com+86 13791122770

Outcome results

None listed

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