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Clinical Trial VICCTHN1303


A Randomized Open-Label Phase II Trial of Pemetrexed and a Platinum (Carboplatin or Cisplatin) with or without Erlotinib in Patients with Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutations and Acquired Resistance to First-Line EGFR TKIs, Erlotinib or Gefitinib

Principal Investigator(s)

Leora Horn


  • Protocol No. VICCTHN1303
  • Open Date: 06/06/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the effects of chemotherapy plus erlotinib vs. chemotherapy alone on PFS in NSCLC patients harboring activating EGFR mutations who developed acquired resistance to first-line therapy with erlotinib
  • Disease Sites: Lung; Non Small Cell
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Alimta; Carboplatin; Cisplatin; Pemetrexed; Tarceva (OSI-774; erlotinib)
  • Participating Institutions: CITY OF HOPE NATIONAL MEDICAL CENTER; Dana-Farber Cancer Institute; Washington University Ctr for Clinical Studies; Baptist Hospital; Columbia University Medical Center; Vanderbilt University
  • National Clinical Trial ID: NCT01928160
  • Secondary Protocol No: Not Specified


None Provided.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Signed informed consent prior to initiation of any study-specific procedure or treatment
• Able to comply with the protocol
• Histologically- or cytologically-confirmed stage IV NSCLC with an EGFR exon-19 deletion or L858R mutation
• Must have received at least 6 months of first-line therapy with erlotinib
• Clinical evidence of progression on first-line EGFR TKI therapy
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L AND
• Platelet count >= 100 x 10^9/L AND
• Hemoglobin >= 9 g/dL (may be transfused to maintain or exceed this level)
• Total bilirubin < 1.5 x upper limit of normal (ULN) AND
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5 x ULN in patients with liver metastases
• Serum creatinine < 1.25 x ULN or calculated creatinine clearance > 50 mL/min
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patients with stable, treated brain metastases are eligible for study participation; patients may not receive ongoing treatment with steroids at screening; anticonvulsants (at stable dose) are allowed; radiotherapy and stereotactic radiosurgery must be completed at least 28 days prior to randomization
• Female patients should not be pregnant or breast-feeding; female patients with childbearing potential should agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of at least 6 months following the last administration of study drugs; female patients with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study
• Fertile male patients must agree to use effective contraception during the study and for a period of at least 3 months following the last administration of study drugs
Exclusion Criteria:
• Any other prior treatment for metastatic NSCLC other than erlotinib; prior adjuvant therapy is allowed if completed at least 12 months prior to trial enrollment
• Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions up to 14 days prior to randomization
• Clinically significant (i.e., active) cardiovascular disease (e.g., cerebrovascular accident or myocardial infarction within 6 months prior to randomization), unstable angina, congestive heart failure (New York Heart Association class >= II), or serious cardiac arrhythmia, that is uncontrolled by medication or may interfere with administration of study treatment
• Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to randomization
• Malignancies other than NSCLC within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with radiation or surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications