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A Study of Maintenance EGFR-TKI in Advanced lung adenocarcinoma patients after chemotherapy with different cycles

Assess the Efficacy of EGFR-TKI as Maintenance Therapy in Locally Advanced (Stage IIIB/IV) Lung Adenocarcinoma after chemotherapy with 4 cycles vs 2 cycles

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001850
Enrollment
Unknown
Registered
2011-12-15
Start date
2010-10-01
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

Lung Cancer

Interventions

4 cycles:Pemetrexed with Cisplatin or Docetaxel with Cisplatin for 4 cycles
2 cycles:Pemetrexed with Cisplatin or Docetaxel with Cisplatin for 2 cycles

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with histologically or cytologically confirmed Untreated stage IIIB or stage IV advanced primary non-small cell lung cancinoma; 2. Patients with measurable locally advanced or metastatic renal cell carcinoma; 3. Age of 18-75 years; 4. ECOG performance status 0-2; 5. the patients of IIIB-IVstage NSCLC,life expectancy > 3 months; 6. Without Other tumors history; 7. Functions of major organs (heart, liver, kidney) are basically normal; 8. Patients with better compliance; 9. A negative pregnancy test must be documented at Screening for females of childbearing potential,7 days before the trial; 10. Agree to use double-barrier contraception (males and females alike)during the trial and next 3 months.

Exclusion criteria

Exclusion criteria: 1. Previous targeted treatment of TKI or EGFR antibodies prior to inclusion in the trial; 2. Known brain or spinal cord metastases; 3. Any infection(judged by the investigaithtor); 4. Major organ dysfunction,such as decompensation of heart and lung dysfunction; 5. Myocardial infarction and cerebral infarction(=3.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;RR;

Countries

China

Contacts

Public ContactShunchang Jiao
jiaosc@vip.sina.com+86 10 66939761

Outcome results

None listed

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