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A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers

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

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Trial Information

A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers

The treatment of advanced NSCLC cancer includes various chemotherapies with equivalent
regimens that have reached a therapeutic plateau. The selection of these regimens is
completely empirical and physician dependent. Potential predictors of specific agent
efficacy exist in the form of tumor molecular markers that are a reflection of the
individual's genetic make up. Thus our study aims at utilizing these markers to more
efficiently select the regimen in order to maximize the benefit to the patients rather than
using empiric approaches. Fortunately, each of our selected regimens contains active and
well-studied agents in the treatment of lung cancer (Table 1). This pilot study will help
us determine the benefit, and safety of this approach (not individual regimen). The study
is not to compare individual regimens but it aims at testing the whole concept of
customization of chemotherapy based on molecular markers to help us in the future at
selecting regimens based on these markers and not empirically. The results then will be used
to determine more definitive future studies.

Furthermore, circulating tumor cells in the blood represent the future distant metastases
that result in disease progression to incurable stages. The circulating tumor cells have the
ability to cross into vessels, travel in circulation, and exit the vessels into tissues
where they have the capability to grow. Therefore, these cells may express different
biological and molecular features from the stationary cells in the primary tumors.
Therefore, exploiting these circulating tumor cells for augmenting treatment approaches is
of vital importance and utility.

Inclusion Criteria:

1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV

2. Having adequate tissue sample to perform the markers testing

3. Age ≥ 18 years

4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are

5. No other concurrent cancer treatment

6. Performance status of 0- 2 per ECOG scale (Appendix II)

7. Adequate laboratory values as follows as follows:

Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤
1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal
level Serum creatinine ≤ 1.5 X institutional upper normal level

8. Presence of measurable disease

Exclusion Criteria:

1. Prior systemic treatment for lung cancer

2. History of hypersensitivity to drugs used

3. Diagnosis of other malignancy in the last 5 years excluding curatively treated
non-melanoma skin cancer and in-situ cervical cancer

4. Medical illness that puts the patient at significant risk per investigator's

5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with
radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after
the treatment initiation without increase dose of steroids

6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology
consultant for contraception)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy and Safety

Outcome Description:

Efficacy is measured by: overall response rate (partial response and complete response) using RECIST Criteria time to disease progression (TTP) progression free survival (PFS) overall survival (OS) To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 5 parameters to be collected for all patients who receive the study regimen which are: Adverse Events Laboratory Assessments Vital Signs Physical Examinations ECG

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Abdulrahman Jazieh, MD/MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Abdul Aziz Medical City for National Guard


Saudi Arabia: Ethics Committee

Study ID:




Start Date:

May 2010

Completion Date:

May 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms