JPRN-UMIN000002789
Completed
Phase 2
Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902) - Continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in NSCLC with EGFR mutations
orth East Japan Study Group/The Tokyo Cooperative Oncology Group0 sites80 target enrollmentNovember 20, 2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- on-small cell lung cancer with EGFR mutations (non-squamous histology)
- Sponsor
- orth East Japan Study Group/The Tokyo Cooperative Oncology Group
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Presence of active interstitial pneumonia 2\) Resistant T790M mutation 3\) Unstable metastases to the brain 4\) History of radiotherapy for primary lesion 5\) Severe and uncontrolled complication 6\) Severe gastroenterological and intestinal disease 7\) Treatment with steroid for longer than 4 weeks 8\) Uncontrolled pleural effusion or ascites 9\) Pregnant patients 10\) Gefitinib contraindication 11\) Other active malignancies 12\) Decision of ineligibility by a physician
Outcomes
Primary Outcomes
Not specified
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