Randomized Phase IV Trial of Molecular Analysis-Directed Individualized Therapy in Advanced Non-Small-Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001327

Enrollment

Unknown

Registered

2011-04-15

Start date

2011-02-01

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

EGFR mutation (-), RRM1 (+), ?-Tubulin? (-):Vinorelbine +cisplatin

EGFR mutation (-), RRM1 (+), ?-Tubulin? (+):Etoposide+cisplatin

EGFR mutation (+):Erlotinib

control:Vinorelbine +cisplatin of Gemcitabine+cisplatin or Paclitaxel+cisplatin

EGFR mutation (-), RRM1 (-), ?-Tubulin? (-):Vinorelbine +cisplatin of Gemcitabine+cisplatin or Paclitaxel+cisplatin

EGFR mutation (-), RRM1(-), ?-Tubulin? (+):Gemcitabine+cisplatin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 75, PS score of 0-2, predictive survival equal or more than 4 months and can be followed up; 2. Patients with NSCLC (stage of IIIb/IV) confirmed histopathologically; 3. According to RECIST criterion, with clear-cut, measurable and evaluable tumor focuses; 4. Blood Constituents, cardiopulmonary functions, hepatic and renal functions and results of urine routine are basically normal: ALT =3000/mm3, Neutro>=1500/mm3, HB>=9 .0g/dL; 5. No history of other malignant neoplastic diseases; 6. Patients with CNS metastases (have not been treated yet) can also be included; 7. No history of serious diseases of heart, liver, kidney, blood and endocrine system; 8. For females of child-bearing age, pregnancy test should be negative and contraception methods should be adpoted.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast-feeding females; 2. For patients without hepatic metastasis, the levels of AST>=2.5*UNL and ALT>=2.5*UNL, and bilirubin>=1.5*UNL; for patients with hepatic metastasis, the levels of AST>=5*UNL and ALT>=5*UNL, and bilirubin>=1.5*UNL; 3. Patients with uncontrolled brain metastases; 4. Patients with clinical features of anisorhythmia, myocardial ischemia, severe atrioventricular block, cardiac inadequacy and severe valvular disease; 5. Patients intolerable for the side effects of chemotherapy such as severe gastrointestinal reaction, enterorrhea and significant decrease in leukocyte count, which is not improved by the administration of leucocyte-stimulating agents; 6. Patients with the history of severe mental illness or poor compliance; 7. Patients participate in other clinical trials within 4 months of enrollment; 8. Patients unsuitable for this trial.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival;	—

Secondary

Measure	Time frame
Objective Response Survial;median survival time;Toxicity;quality of life;overall survival;	—

Countries

China

Contacts

Public ContactYuqing CHEN

bbmccyq@126.com+86 13695528585

Outcome results

None listed

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