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Report for Clinical Trial NCT01861223

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT01861223 NSCLC

1 Interventions

Name: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)

Type: Drug

afatinib + nimotuzumab

Primary Outcomes

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

Measure: Maximal tolerated dose

Time: 4 weeks

Purpose: Treatment

Single Group Assignment

There is one SNP


1 L858R

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. --- L858R ---

HPO Nodes