Back to results

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

Primary Purpose

Non Small Cell Lung Cancer, Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Gefitinib

Placebo

Pemetrexed plusCIsplatin

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring lung adenocarcinoma, never smoker, 1st line treatment, Intercalation administration, Gefitinib, never smokers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Stage IIIB (not amenable for radical loco-regional therapy) or stage IV (metastatic) patients according to the 7th TNM staging system
Age 18-75
Never-smoking defined as not more than 100 cigarettes during the lifetime
ECOG performance status of 0-2
Good organ function
The presence of CNS metastases is not considered as an exclusion criterion, provided that there is good control of the symptoms with corticosteroids
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:

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

Sites / Locations

National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study arm

Placebo arm

Arm Description

Pemetrexed plus Cisplatin plus Gefitinib

Pemetrexed plus Cisplatin plus Placebo

Outcomes

Primary Outcome Measures

To compare progression-free survival

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

Secondary Outcome Measures

To compare objective response rate (CR+PR)

every 9 weeks until PD

To compare duration of response.

To compare non progression rate (CR+PR+SD) at 16 weeks.

To compare overall survival.

To compare number of Grade 3/4 Adverse Events

Participants will be followed for the duration of chemotherapy. CTCAE version 4.0

To assess biomarker

Full Information

NCT ID

NCT01502202

First Posted

December 22, 2011

Last Updated

June 19, 2012

Sponsor

National Cancer Center, Korea

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01502202

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2012 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer, Adenocarcinoma

Keywords

lung adenocarcinoma, never smoker, 1st line treatment, Intercalation administration, Gefitinib, never smokers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study arm

Arm Type

Active Comparator

Arm Description

Pemetrexed plus Cisplatin plus Gefitinib

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

Pemetrexed plus Cisplatin plus Placebo

Intervention Type

Drug

Intervention Name(s)

Gefitinib

Other Intervention Name(s)

AP-G

Intervention Description

Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

AP-P

Intervention Description

Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)

Intervention Type

Drug

Intervention Name(s)

Pemetrexed plusCIsplatin

Other Intervention Name(s)

Standard chemotherapy

Intervention Description

Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles

Primary Outcome Measure Information:

Title

To compare progression-free survival

Description

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

Time Frame

minimum 1-year follow-up

Secondary Outcome Measure Information:

Title

To compare objective response rate (CR+PR)

Description

every 9 weeks until PD

Time Frame

minimum 1-year follow-up

Title

To compare duration of response.

Time Frame

minimum 1-year follow-up

Title

To compare non progression rate (CR+PR+SD) at 16 weeks.

Time Frame

at 16 weeks

Title

To compare overall survival.

Time Frame

minimum 1-year follow-up

Title

To compare number of Grade 3/4 Adverse Events

Description

Participants will be followed for the duration of chemotherapy. CTCAE version 4.0

Time Frame

average up to 1 year

Title

To assess biomarker

Time Frame

minimum 1-year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Stage IIIB (not amenable for radical loco-regional therapy) or stage IV (metastatic) patients according to the 7th TNM staging system Age 18-75 Never-smoking defined as not more than 100 cigarettes during the lifetime ECOG performance status of 0-2 Good organ function The presence of CNS metastases is not considered as an exclusion criterion, provided that there is good control of the symptoms with corticosteroids 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: Patients with prior exposure to agents directed at the HER Patients with prior chemotherapy or therapy with systemic anti-tumour therapy for advanced disease. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. Known severe hypersensitivity to gefitinib or to any of the study drugs. Any evidence of clinically active interstitial lung disease Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort Prior invasive malignancies 3 years prior to study entry except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer As judged by the investigator, any evidence of severe or uncontrolled systemic disease Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. Pregnancy or breast-feeding (women of child-bearing potential). Sexually active males and females (of childbearing potential) unwilling to practice acceptable methods of birth control

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Soo Lee, M.D. PhD.

Phone

+82-31-920-1501

jslee@ncc.re.kr

First Name & Middle Initial & Last Name or Official Title & Degree

SUNG JIN YOON, RN

Phone

+82-31-920-0405

jinijiniya@ncc.re.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Soo Lee, M.D. PhD.

Organizational Affiliation

National Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center

City

Goyang-si

State/Province

Gyenggido

ZIP/Postal Code

410-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung Jin Yoon, RN

Phone

+82-31-920-0405

jinijiniya@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Jin Soo Lee, MD. Ph.D.

Phone

+82-31-920-1501

jslee@ncc.re.kr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs