Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer

Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer - Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004876

Enrollment

100

Registered

2011-01-15

Start date

2010-06-01

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-squamous non-small cell lung cancer

Interventions

Pemetrexed after induction therapy of pemetrexed plus cisplatin Pemetrexed after induction therapy of pemetrexed plus carboplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer. (Non-Squamous NSCLC). 2)Stage III/IV unresectable or unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC. 3)No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least six months interval from the last dosage of adjuvant chemotherapy. 4) Measurable tumor sites 5) ECOG-PS of 0 or 1. 6)No prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial. 7) Life expectancy more than 3 months. 8) Adequate organ function. 9) Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan. 2)Patients with active co-morbidities including severe conditions. (1)uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease. (2)uncontrollable diabetes, hypertension. (3)severe infection (4)paresis of intestine, illeus (5)Patients whose participation in the trial is judged to be inappropriate by the attending doctor. 3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated. 4) Brain metastases with neurological symptoms. 5) SVC syndrome. 6) Active double cancer. 7)Pregnancy, breast feeding and suspected pregnancy. 8)History of grave drug allergic reaction. 9) Psychiatric disorder. 10) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.

Design outcomes

Primary

Measure	Time frame
PFS: progression free survival It verifies that PFS is 4.5 months or more in each arm.	—

Secondary

Measure	Time frame
QOL: quality of life RR: response rate DCR: disease control rate OS: overall survival Maintenance treatment shift rate AE: adverse events	—

Countries

Japan

Contacts

Public ContactSeisuke Nagase

International University of Health and Welfare Respiratory Disease Center

snagase@iuhw.ac.jp03-3454-0067

Outcome results

None listed

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