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A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of AZD2171 Alone and in Combination With AZD2171 and Pac/Carb

A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of AZD2171 Alone and in Combination With AZD2171 and Pac/Carb

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220478
Enrollment
Unknown
Registered
2007-12-07
Start date
2007-12-07
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

investigational material(s) Generic name etc : AZD2171 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Inclusion Criteria: - Having histologically or cytologically confirmed NSCLC - Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC - WHO performance status 0-1 Exclusion Criteria: - Untreated unstable brain or meningeal metastases - Patient with inappropriate laboratory tests values - Patient with poorly controlled hypertension

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Safety/Efficacy Primary Outcome Measures: PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS) [ Time Frame: time to progression ] Secondary Outcome Measures: PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival [ Time Frame: time to death ]—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026