Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01502202
Recruitment Status : Unknown
Verified June 2012 by Jin Soo Lee, National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : December 30, 2011
Last Update Posted : June 20, 2012
Information provided by (Responsible Party):
Jin Soo Lee, National Cancer Center, Korea

Brief Summary:
Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle improve the efficacy of Pemetrexed/platinum regimen given as first-line treatment for never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Adenocarcinoma Drug: Gefitinib Drug: Placebo Drug: Pemetrexed plusCIsplatin Phase 2

Detailed Description:

Investigators believe this PFS curve crossing-over in both IPASS and First-SIGNAL study is mainly due to early progression of EGFR mutation-negative tumors after gefitinib alone. Taken together with the FASTACT trial results, this PFS curve crossing-over may well be averted if effective chemotherapy is given together with gefitinib in a most optimum timing and sequence. Apparently, timing of EGFR-TKI administration within chemotherapy cycles is very critical, as shown in OSI 9774 trial.

In this placebo-controlled randomized phase II, Investigators propose to give gefitinib on days 5-18 of a 3-weekly chemotherapy cycle of pemetrexed/cisplatin to avoid any potential overlap of EGFR-TKI effects on chemotherapy or vice versa. Investigators would like to generate promising pilot data, which warrants a large phase III trial. Investigators hope to show that intercalated administration of Iressa® (gefitinib) and Pemetrexed/platinum regimen improves the outcome of never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-controlled Phase II Study of Intercalated Administration of Pemetrexed/Cisplatin With Iressa® (Gefitinib) or Placebo as First-line Treatment of Stage IIIB/IV Lung Adenocarcinoma in Never-smokers
Study Start Date : March 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : February 2015

Arm Intervention/treatment
Active Comparator: Study arm
Pemetrexed plus Cisplatin plus Gefitinib
Drug: Gefitinib
Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)
Other Name: AP-G

Drug: Pemetrexed plusCIsplatin
Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles
Other Name: Standard chemotherapy

Placebo Comparator: Placebo arm
Pemetrexed plus Cisplatin plus Placebo
Drug: Placebo
Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)
Other Name: AP-P

Drug: Pemetrexed plusCIsplatin
Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles
Other Name: Standard chemotherapy

Primary Outcome Measures :
  1. To compare progression-free survival [ Time Frame: minimum 1-year follow-up ]

    from date of randomization until the date of first documented progression or death from any case.

    Assessed minimum 1 years.

Secondary Outcome Measures :
  1. To compare objective response rate (CR+PR) [ Time Frame: minimum 1-year follow-up ]
    every 9 weeks until PD

  2. To compare duration of response. [ Time Frame: minimum 1-year follow-up ]
  3. To compare non progression rate (CR+PR+SD) at 16 weeks. [ Time Frame: at 16 weeks ]
  4. To compare overall survival. [ Time Frame: minimum 1-year follow-up ]
  5. To compare number of Grade 3/4 Adverse Events [ Time Frame: average up to 1 year ]
    Participants will be followed for the duration of chemotherapy. CTCAE version 4.0

  6. To assess biomarker [ Time Frame: minimum 1-year follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of lung with or without BAC features; however, adenocarcinoma combined with other histology, such as small cell carcinoma or squamous carcinoma, is not allowed.
  2. Stage IIIB (not amenable for radical loco-regional therapy) or stage IV (metastatic) patients according to the 7th TNM staging system
  3. Age 18-75
  4. Never-smoking defined as not more than 100 cigarettes during the lifetime
  5. ECOG performance status of 0-2
  6. Good organ function
  7. The presence of CNS metastases is not considered as an exclusion criterion, provided that there is good control of the symptoms with corticosteroids
  8. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. The only approved consent form is attached to this protocol

Exclusion Criteria:

  1. Patients with prior exposure to agents directed at the HER
  2. Patients with prior chemotherapy or therapy with systemic anti-tumour therapy for advanced disease.
  3. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
  4. Known severe hypersensitivity to gefitinib or to any of the study drugs.
  5. Any evidence of clinically active interstitial lung disease
  6. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
  7. Prior invasive malignancies 3 years prior to study entry except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
  8. As judged by the investigator, any evidence of severe or uncontrolled systemic disease
  9. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  10. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  11. Pregnancy or breast-feeding (women of child-bearing potential).
  12. Sexually active males and females (of childbearing potential) unwilling to practice acceptable methods of birth control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01502202

Layout table for location contacts
Contact: Jin Soo Lee, M.D. PhD. +82-31-920-1501
Contact: SUNG JIN YOON, RN +82-31-920-0405

Layout table for location information
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyenggido, Korea, Republic of, 410-769
Contact: Sung Jin Yoon, RN    +82-31-920-0405   
Contact: Jin Soo Lee, MD. Ph.D.    +82-31-920-1501   
Sponsors and Collaborators
National Cancer Center, Korea
Layout table for investigator information
Principal Investigator: Jin Soo Lee, M.D. PhD. National Cancer Center
Layout table for additonal information
Responsible Party: Jin Soo Lee, Principal Investigator, National Cancer Center, Korea Identifier: NCT01502202    
Other Study ID Numbers: NCCCTS-11-581
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012
Keywords provided by Jin Soo Lee, National Cancer Center, Korea:
lung adenocarcinoma
never smoker
1st line treatment
Intercalation administration
never smokers
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma of Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors