A randomized Phase II study of Carboplatin + Pemetrexed followed by Pemetrexed versus Carboplatin+Pemetrexed followed by Erlotinib in patients with advanced Non-squamous and Non- Small Cell Lung Cancer without EGFR mutations

A randomized Phase II study of Carboplatin + Pemetrexed followed by Pemetrexed versus Carboplatin+Pemetrexed followed by Erlotinib in patients with advanced Non-squamous and Non- Small Cell Lung Cancer without EGFR mutations - LOGIK1301

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011126

Enrollment

120

Registered

2013-07-05

Start date

2013-07-25

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

Pemetrexed 500mg/sqm+CBDCA AUC 6: intravenous q3w 4cycles Pemetrexed 500mg/sqm:intravenous q3w Pemetrexed 500mg/sqm+CBDCA AUC 6: intravenous q3w 4cycles Erlotinib 150mg/day, oral daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Provided written informed consent 2) Histologically or cytologically confirmed non-squamous NSCLC,prior chemotherapy (containing EGFR-TKIs) is not accepted 3) Measurable lesions (RECIST) 4) StageIIIB/IV or postoperative recurrence NSCLC 5) EGFR mutation negative 6) Age>=20years 7) ECOG PS 0-1 8) Adequate function of main organ 9) Expected survival over 3 months

Exclusion criteria

Exclusion criteria: 1) Active severe comorbidity disease. 2) Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 3) Patients with symptomatic Brain metastases. 4) Active concomitant malignancy. 5) History of grave drug allergic reaction. 6) Pregnant or breast-feeding females. 7) Unstable psychic disorder. 8) Accepted continuous use of steroid. 9) Administration of folic acid and vitamin B12 is not received. 10) Diagnosed EML4-ALK fusion gene positive. 11) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Overall Survival Safety Biomarker analysis Objective Response Rate	—

Countries

Japan

Contacts

Public ContactMasafumi Takeshita

Kitakyushu Municipal Medical Center Respiratory medicine

Ikyoku175@kmmc.jp093-541-1831

Outcome results

None listed

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