A randomized phase II study of Cisplatin plus S-1 versus Cisplatin plus Pemetrexed, with thoracic radiotherapy for locally advanced non-squamous non-small cell lung cancer

A randomized phase II study of Cisplatin plus S-1 versus Cisplatin plus Pemetrexed, with thoracic radiotherapy for locally advanced non-squamous non-small cell lung cancer - Randomized phase II study of CDDP+S-1+TRT vs. CDDP+PEM+TRT for locally advanced non-sq NSCLC.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009914

Enrollment

100

Registered

2013-01-31

Start date

2013-01-04

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-squmous non-small cell lung cancer

Interventions

Combination chemotherapy of S-1 plus cisplatin and concurrent thoracic radiotherapy Combination chemotherapy of pemetrexed plus cisplatin and concurrent thoracic radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Pathologically proven non-squamous non-small cell lung cancer (2) Clinical stage IIIA or IIIB based on the UICC TNM classification 7th edition (3) Unresectable (4) Having indication of defenitive thoracic radiotherapy (5) No prior chemotherapy or radiotherapy (6) ECOG PS of 0 or 1 (7) PaO2 >= 70 Torr or SpO2 >= 93% (8) Adequate organ function (9) Expected the rest of life over 12 weeks (10) Age of 20 to 70 years (11) Written informed consent by patients

Exclusion criteria

Exclusion criteria: (1) active concomitant malignancy (2) Infection, ileus, or gastrointestinal obstruction (3) Uncontrolled peptic ulcer or diabetes (4) Intestinal pneumonia or severe emphysema (5) Severe drug allergy (6) Concomitant use of other investigational drugs, warfarin, or flucytosine (7) Positive of HBsAg (8) Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival rate	—

Secondary

Measure	Time frame
Rate of treatment completion, rate of adverse events, response rate, overall survival	—

Countries

Japan

Contacts

Public ContactSeiji Niho

National Cancer Center Hospital East Department of Thoracic Oncology

siniho@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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