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)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002789

Enrollment

Registered

2009-11-20

Start date

2009-12-01

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

Non-small cell lung cancer with EGFR mutations (non-squamous histology)

Interventions

Continuous gefitinib plus chemotherapy (Carboplatin + Pemetrexed) Alternation of gefitinib and chemotherapy (Carboplatin + Pemetrexed)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven NSCLC (non-squamous histology) 2) Stage IIIB, IV, or relapsed NSCLC 3) NSCLC harboring sensitive EGFR mutations 4) At least one measurable lesion 5) Chemotherapy-naive patients 6) Over 20 years old and under 75 years old 7) ECOG performance status of 0-1 8) Adequate organ functions (WBC >= 4,000 /mm3, Neutrophil >= 2,000 /mm3, Platelet >= 100,000 /mm3, Hemoglobin concentration >= 9.0 g/dl, AST or ALT <= twice the number of ULN, T-bilirubin <= 1.5 mg/dl, Cr <= 1.5 mg/dl, PaO2 or SpO2 >= 60 Torr or 95%) 9) Life expectancy of at least 3 months 10) Written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Response rate, overall survival, and safety	—

Countries

Japan

Contacts

Public ContactSatoshi Oizumi

National Hospital Organization Hokkaido Cancer Center Department of Respiratory Medicine

soizumi@hokkaido.med.or.jp011-811-9111

Outcome results

None listed

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