Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia

Phase II study of Pemetrexed + Carboplatin as first line therapy for nonsquamous non-small cell lung cancer with interstitial pneumonia - Phase II study of Pemetrexed + Carboplatin for lung cancer with interstitial pneumonia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011325

Enrollment

Registered

2013-07-31

Start date

2013-09-01

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

no-small and non-squamous lung cancer with interstitial penumonia

Interventions

Pemetrexed and carboplatin combination therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Non-small and non-squamous lung cancer 2) Stable idiopathic interstitial pneumonia confirmed by high resolution chest CT 3) No indication of radiation therapy and surgical resection 4) Chemotherapy naive patients 5) Age over 20 -79 years 6) ECOG Performance status 0-1 7) %FVC >= 66% and %DLCO >= 36% for each predictive values within a month of registration 8) Adequate organ function 9) Life expectancy > 3 months 10) Signed informed consent

Exclusion criteria

Exclusion criteria: 1) Having uncontroled infection 2) Having a fever (more than 38 degrees (Celsius)) 3) Having past history of acute exacerbation of interstitial pneumonia 4) Progression of interstitial pneumonia on chest CT within 3 months 5) Over 21mg/day dose of predonisolone 6) Sarcoidosis and collagen vascular diseases 7) Having past history of drug-induced lung injury and radiation pnumonitis 8) Having severe complications 9) Active concomitant malignancy without evidence of recurrence within 5 years 10) Having an uncontrolable pleural effusion 11) Having allergy for pemetrexed or carboplatin 12) History of pregnancy or lactation 13) Decision of ineligibility by the attending physician

Design outcomes

Primary

Measure	Time frame
The frequency of severe lung injury on 28 days after the last chemotherapy	—

Secondary

Measure	Time frame
Response rate, disease control rate, overall survival and progression free survival	—

Countries

Japan

Contacts

Public ContactAkira Shiraki

Ogaki Municipal Hospital Respiratory Medicine

akira.shiraki@gmail.com0584-81-3341

Outcome results

None listed

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