Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors

A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01449357

Enrollment

Registered

2011-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2011-10-10

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

Keywords

NSCLC, Zalutumumab, Efficacy, Safety

Brief summary

A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.

Interventions

DRUGzalutumumab

IV infusion, 16mg/kg on weekly basis until DP

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).

Exclusion criteria

* Estimated life expectancy of less than 3 months. * Received the following treatments within 2 weeks prior to Visit 2: * Cytotoxic or cytostatic anti-cancer chemotherapy * Total resection or irradiation of the target lesion * Any investigational agent

Design outcomes

Primary

Measure	Time frame
Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.	within 6 months

Secondary

Measure	Time frame
Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months.	within 6 months

Outcome results

None listed

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