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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

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

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Trial Information

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

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.

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To compare progression-free survival

Outcome Description:

from date of randomization until the date of first documented progression or death from any case. Assessed minimum 1 years.

Outcome Time Frame:

minimum 1-year follow-up

Safety Issue:


Principal Investigator

Jin Soo Lee, M.D. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

March 2012

Completion Date:

February 2015

Related Keywords:

  • Non Small Cell Lung Cancer
  • Adenocarcinoma
  • lung adenocarcinoma
  • never smoker
  • 1st line treatment
  • Intercalation administration
  • Gefitinib
  • never smokers
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms