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Clinical Phase II Study on the first-line chemotherapy for IIIB-IV stage Non-squmaous cell lung cancer, comparing Pemetrexed/Carboplatin with Gemcitabine/Carboplatin.

Clinical Phase II Study on the first-line chemotherapy for IIIB-IV stage Non-squmaous cell lung cancer, comparing Pemetrexed/Carboplatin with Gemcitabine/Carboplatin.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000546
Enrollment
Unknown
Registered
2009-09-14
Start date
2009-07-15
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

?B-? stage Non-squmaous NSCLC

Interventions

Group A:Pemetrexed 500mg/m2 d1 + CBP AUC=5 d1 q21d
Group B:GEM 1000mg/m2 d1.d8 + CBP AUC=5 d8 q21d

Sponsors

People's hospital of Dongguan, Guangdong Province, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male and female aged 18 years old and over; 2. ECOG PS0-1; 3. Non-squamous NSCLC including adenocarcinoma, bronchioloalveolar carcinoma, large cell carcinoma, undifferential carcinoma, confirmed with histology or cytology, without small cell or squamous component; 4. Initial treatment for advanced non–squamous NSCLC; 5. Expecting life-span, more than twelve weeks; 6. Never have received systemic antitumor treatment before; 7. Have signed the informed consent form; 8. Have evaluating lesions; 9. If with brain metastasis, must without symptoms, such as intracranial hypertension syndrome (nausea, vomit, headache), obstruction in cognition and emotion, epilepsy, lesion-local symptoms; 10. Follow the progress of study and surveillance.

Exclusion criteria

Exclusion criteria: 1. Any unstable systemic diseases (active infection, un-well controlled hypertension, unstable angina, congested heart failure, serious liver or kidney disease, metabolic diseases); 2. Have received systemic antitumor treatment before; 3. Brain metastasis with symptoms; 4. Pregnant female; 5. Hemoglobin less than 8g/dl, or neutrophil leucocytes less than 1.5*10^9/L, platelets less than 75*10^9/L; 6. Serum bilirubin, more than 1.5 times of the upper normal limit. AST and ALT, more than 2 times of the upper normal limit. If excising liver metastasis, AST and ALT, more than 5 times of the upper normal limit; 7. Serum creatinine, more than 1.5 times of the upper normal limit, or creatinine clearance rate less than 50ml/min.

Design outcomes

Primary

MeasureTime frame
Overall response rate;

Countries

China

Contacts

Public ContactYun Jia
dgryjy@sina.com+86 13662810048

Outcome results

None listed

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