PhaseII study of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer acquired resistance to first line gefitinib monotherapy.

PhaseII study of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer acquired resistance to first line gefitinib monotherapy. - PhaseII study of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer acquired resistance to first line gefitinib monotherapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005690

Enrollment

Registered

2011-06-02

Start date

2011-06-01

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

Interventions

Gefitinib combined with cisplatin plus pemetrexed followed by gefitinib monotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-squamous non-small cell lung cancer. 2) Cytotoxic agents naive and clinical stage stage IIIB, IV (UICC-7) or recurrent disease after surgery. Measurable lesion is not necessary. 3,4) Harboring sensitizing EGFR mutation and acquired resistance to first line gefitinib monotherapy. 5) Age: over 20 years old. 6) ECOG performance status of 0 or 1. 7) Adequate organ function. 8) Life expectancy more than 12 weeks. 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Impossible cases with protcol defined oral administration. 2) Patients with symptomatic brain metastasis. 3) With active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis. 4) Thoracic radiation, within 4 weeks, irradiation to other organs within 2 weeks. 5) Uncontrollable pleural or pericardial effusion. 6) Operation within 4 weeks. 7) Active infection. 8) Active concomitant malignancy. 9) Severe drug allergy. 10) Pregnant or breast-feeding woman. 11) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
6 months progression free survival rate	—

Secondary

Measure	Time frame
Overall survival Response rate Progression free survival Adverse events	—

Countries

Japan

Contacts

Public ContactHiroaki Akamatsu

Shizuoka Cancer Center Division of Thoracic Oncology

h.akamatsu@scchr.jp

Outcome results

None listed

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