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


Phase 1/Phase 2
20 Years
N/A
Not Enrolling
Both
NSCLC

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal tolerated dose

Outcome Description:

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

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

2012-11-087-007

NCT ID:

NCT01861223

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • NSCLC
  • acquired resistance
  • gefitinib
  • erlotinib

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