Phase I trial of Afatinib intercalated with Carboplatin/Pemetrexed Chemotherapy in advanced non-squamous non-small-cell lung cancer harboring EGFR mutations.

Phase I trial of Afatinib intercalated with Carboplatin/Pemetrexed Chemotherapy in advanced non-squamous non-small-cell lung cancer harboring EGFR mutations. - NEJ025A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015582

Enrollment

Registered

2014-11-01

Start date

2014-11-04

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

1) Stage IIIB, IV or relapsed non-squamous cell carcinoma in non-small cell lung cancer 2) Harboring sensitive EGFR mutations 3) After progress disease of 1st line treatment by gefitinib or erlotinib

Interventions

the combination therapy consisted of carboplatin (CBDCA), pemetrexed (PEM) and afatinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Stage IIIB, IV or relapsed non-squamous cell carcinoma in non-small cell lung cancer 2) Harboring sensitive EGFR mutations 3) After progress disease of 1st line treatment by gefitinib or erlotinib 4) No prior treatment by cytotoxic chemotherapy 5) Performance Status (ECOG) 0, 1 6) Having adequate organ functions a) neutrophil count >=1,500 /mm3 b) WBC >=3,000 /mm3 c) platelet >=100,000 /mm3 d) Hemoglobin >=9.0 g/dL e) AST / ALT <=2.5 times of normal upper limit f) Total bilirubin <=1.5 g) Serum creatinine <=1.5 h) Creatinine clearance >= 45mL/min (Cockcroft-Gault) i) SPO2 >=93% 7) Life expectancy of more than 3 months 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Having problematic interstitial lung disease or lung fibrosis on chest CT 2) Having prior treatment(s) by afatinib and/or pemetrexed 3) Having persistent Grade >=2 non-hematological toxicity by gefitinib or erlotinib 4) Having uncontrollable pleural and/or peritoneal effusion 5) Having symptomatic brain metastasis 6) After radiotherapy for primary lesion 7) Having problematic complication(s) 8) Having infectious disease to be treated 9) Having active, double cancer 10) Having sever malabsorption syndrome 11) Pregnant women, or having possibility of pregnancy; man having no intent to birth control 12) Having psychological disorder 13) In addition, the primary doctor judging inappropriate for entry

Design outcomes

Primary

Measure	Time frame
MTD, Dose Limiting Toxicity (DLT), Recomennded Dose (RD)	—

Countries

Japan

Contacts

Public ContactSatoshi Watanabe

Niigata University Medical and Dental Hospital Bioscience Medical Research Center

satoshi7@med.niigata-u.ac.jp+81-25-223-6161

Outcome results

None listed

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