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A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status

Advanced NSCLC holds a very poor prognosis with a moderate response rate to standard
chemotherapy. The standard first-line treatment for advanced NSCLC is platinum based
combination chemotherapy. The response rates are less than 30% and a substantial amount of
patients will experience unnecessary toxicity in terms of e.g. nausea, vomiting,
neuropathies or a considerable risk of renal toxicity. The median progression free survival
is 3-4 months and consequently, the median overall survival is less than one year (Hotta et
al 2007). Addition of new biological agents to standard chemotherapy regimens may improve
the outcome for these patients.

Inclusion Criteria:

- Histologically confirmed metastatic (stage IV) NSCLC

- Measurable disease according to RECIST v.1.0 2009

- KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue.

- Age ≥18

- PS < 2

- Adequate organ function


- Neutrophil count ≥1.5x10^9/L

- Platelet count ≥100x10^9/L

- Leucocyte count > 3,000/mm

Hepatic function:

- Total bilirubin ≤ 1.5 times the upper normal limit (UNL)

- Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence
of liver metastases

Renal Function:

- Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL

Metabolic function:

- Magnesium ≥ lower limit of normal.

- Calcium ≥ lower limit of normal.

Consent to translational research studies

Written informed consent

Exclusion Criteria:

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or
other concurrent disease.

- Known CNS metastasis (pretreatment routine assessment not required)

- Prior chemotherapy for metastatic disease

- Indication for radiation therapy or prior radiotherapy within 30 days before
treatment start.

- Other malignant diseases within 5 years prior to inclusion in the study, except basal
cell squamous carcinoma of the skin and cervical carcinoma-in-situ.

- Other experimental therapy within 30 days prior to treatment initiation.

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan.

- Patients pregnant or breast feeding, or planning to become pregnant within 6 months
after the end of treatment.

- Patients (male or female) not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or
female) after the end of treatment.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Up to 3 years

Safety Issue:



Denmark: Danish Medicines Agency

Study ID:




Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Lung Cancer
  • Non small cell lung cancer
  • Triple mutational status
  • KRAS
  • BRAF
  • PI3K
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms