An exploratory study on efficacy and QOL of Pemetrexed plus Carboplatin followed by Pemetrexed in stage IIIB/IV or recurrent patients with non-squamous NSCLC without EGFR activating mutation.

An exploratory study on efficacy and QOL of Pemetrexed plus Carboplatin followed by Pemetrexed in stage IIIB/IV or recurrent patients with non-squamous NSCLC without EGFR activating mutation. - A study on efficacy and QOL of PEM plus CBDCA followed by PEM in patients with non-Sq NSCLC without EGFR activating mutation.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008937

Enrollment

Registered

2012-09-18

Start date

2012-04-01

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 without EGFR activating mutation

Interventions

Four cycles of Pemetrexed plus Carboplatin followed by Pemetrexed maintenance until disease progression.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer without EGFR activating mutation 2)Recurrent or stage IIIB/IV non-squamous NSCLC patients unsuitable for radical irradiation 3)No prior chemotherapy, or recurrent patients finished adjuvantchemotherapy more than 6 months ago. 4)Measurable tumor sites 5)Karnofsky PS>=60 6)20 years old or older, younger than 80 years old at informed consent 7)Asymptomatic micro brain metastases can be enrolled. Patients who received palliative radiotherapy to brain metastasis and/or bone metastasis 2 weeks or longer before chemotherapy. A case who was given radiation therapy to primary lesion is not allowed. 8)No prior chemotherapy and radiotherapy for other cancer 9)Patients who are expected to survive for more than 3 months 10)Adequate organ function. WBC count:>=4,000/mm3 neutrophil count:>=2,000/mm3 Platelet count:>=100,000/mm3 Hemoglobin:>=9.0g/dl AST,ALT=<100IU/l Total bilirubin:=<2.0mg/dl creatinine:=<1.5mg/dl Ccr>=45ml/min PaO2>=60torr or SpO2>=90% 11)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 as follows. 2-1)Serious heart disease including uncontrollable angina pectoris, myocardial infarction within 3 months, and congestive heart failure. 2-2)Uncontrollable diabetes mellitus, hypertension. 2-3)Severe infection 2-4)Paresis of intestine, illeus 2-5)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	—

Secondary

Measure	Time frame
QOL:Quality of life RR:Response rate DCR:Disease control rate OS:Overall survival AE:Adverse events Maintenance extraction rates Progression free survival in cases given maintenance therapy	—

Countries

Japan

Contacts

Public ContactRyo Koyama

Juntendo University Graduate School of Medicine Department of Respiratory Medicine

rkoyama@juntendo.ac.jp03-5802-1063

Outcome results

None listed

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