A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI

A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI - A phase II study of Erlotinib plus Pemetrexed for Non Small Cell Lung Cancer with T790M negative previously treated with EGFR-TKI

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008033

Enrollment

Registered

2012-06-01

Start date

2012-06-01

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-small cell lung cancer

Interventions

A combined chemotherapy of Erlotinib plus Pemetrexed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer 2) Stage IIIB/IV or postoperative recurrence NSCLC 3) Patients with EGFR mutation (exon 18 or 19 or 21) 4) Patients aged 20 years or older. 5) Previously treated EGFR-TKI 6) Previously treated no or one chemotherapy regimen after EGFR-TKI 7) Patients who do not possess T790M 8) ECOG performance status of 0-2 9) Measureable region evaluable according to the RECIST(ver.1.1) 10) Expected to be observed for at least 2 to 4 weeks in a hospital or in a comparable institution after the initiation of this treatment 11) Adequate organ function. 12) More than 4 weeks after the last chemotherapy 13) Patients who are considered to survive for more than 3 months 14) Written informed consent from the patient

Exclusion criteria

Exclusion criteria: 1) Presence of active interstitial pneumonia, radiation pneumonia, pneumoconiosis, or drug induced pneumonia 2) Uncontrolled pleural effusion, ascites, or pericardial effusion 3) Previously treated with Pemetrexed 4) Patients with active severe infections 5) Impossible cases with oral administration 6) Patients with uncontrollable complications 7) Pregnancy, breast feeding and suspected pregnancy 8) Active concomitant malignancy 9) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Disease control rate	—

Secondary

Measure	Time frame
Response rate Overall survival Progression free survival Safety	—

Countries

Japan

Contacts

Public ContactKazutoshi Isobe

Toho University Omori Medical Center Department of Respiratory Medicine

03-3762-4151

Outcome results

None listed

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