Afatinib Plus Nimotuzumb for NSCLC

A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01861223

Enrollment

Registered

2013-05-23

Start date

2013-05-31

Completion date

2016-05-31

Last updated

2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Keywords

acquired resistance, gefitinib, erlotinib

Brief summary

To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.

Interventions

DRUGafatinib (30 or 40mg) + nimotuzumab (100 or 200mg)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed diagnosis of stage IIIB or IV NSCLC * Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months * Disease progression on treatemtn with gefitinib or erlotinib within 30 days * Biopsy on disease progression * Age ≥20 years * ECOG performance status of 0, 1, or 2 * Measurable disease by the criteria of RECIST 1.1 * Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 45 mL/min

Exclusion criteria

* Known interstitial lung disease * Prior treatment with EGFR targeting antibodies or BIBW 2992 * Prior three or more lines of chemotherapy for advanced NSCLC * Significant bowel disease impairing drug absorption * Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia * Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.

Design outcomes

Primary

Measure	Time frame	Description
Maximal tolerated dose	4 weeks	To establish maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for BIBW 2992 and nimotuzumab in patients with acquired resistance to erlotinib or gefitinib

Countries

South Korea

Contacts

Primary ContactMyung-Ju Ahn

silkahn@skku.edu822-3410-3459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026