Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer.

Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer. - Phase II Study of PEM/CBDCA Followed by PEM for elderly Non-squamous and Non-small Cell Lung Cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006139

Enrollment

Registered

2011-08-10

Start date

2011-08-01

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

PEM/CBDCA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histologically proven non-squamous non-small cell lung cancer (2)Patient who has measurable lesion by RECIST (3)Stage 3B/4 NSCLC (4)ECOG performance status: 0-1 (5)Aged>=70 years (6)No chemotherapy, radiotherapy, immunotherapy as prior therapy as for NSCLC (7)Adequate organ functions (8)Life expectancy >= 3 months (9)Written informed consent

Exclusion criteria

Exclusion criteria: (1)Patients with other clinically significant complications; for example, uncontrollable diabetes and hypertension. (2)Active severe infections. (3)Patients with symptomatic brain metastasis . (4)Patients with massive pleural or pericardial effusion. (5)With prior unapproved drugs or investigational new drugs. (6)Not appropriate to receive the folic acid and vitamin B12 formulation. (7)With peripheral nerves >= grade 2 at enrollment. (8)Continues to NSAIDs during this study. (9)Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
response rate, safety, overall survival, 1 year survival	—

Countries

Japan

Outcome results

None listed

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