Non Small Cell Lung CancerPhase 2NCT01502202
Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers
A Phase 2 study testing Gefitinib and Pemetrexed plusCIsplatin in people with Non Small Cell Lung Cancer and Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Adenocarcinoma
- What is being tested?
- Gefitinib and Pemetrexed plusCIsplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyenggido, 410-769
Sung Jin Yoon, RN, +82-31-920-0405, jinijiniya@ncc.re.kr
Jin Soo Lee, MD. Ph.D., +82-31-920-1501, jslee@ncc.re.kr
About this study
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
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer, Adenocarcinoma
- Being tested
- Gefitinib, Placebo, Pemetrexed plusCIsplatin
- Keywords
- lung adenocarcinoma, never smoker, 1st line treatment, Intercalation administration, Gefitinib, never smokers
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called AP-G
Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)
PlaceboDrug
Also called AP-P
Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)
Pemetrexed plusCIsplatinDrug
Also called Standard chemotherapy
Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Active comparator | Pemetrexed plus Cisplatin plus Gefitinib Receives: Drug: Gefitinib; Drug: Pemetrexed plusCIsplatin |
| Placebo arm | Placebo comparator | Pemetrexed plus Cisplatin plus Placebo Receives: Drug: Placebo; Drug: Pemetrexed plusCIsplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: minimum 1-year follow-up
Secondary outcomes (6)
To compare objective response rate (CR+PR)
every 9 weeks until PD
Measured: minimum 1-year follow-up
To compare duration of response.
Measured: minimum 1-year follow-up
To compare non progression rate (CR+PR+SD) at 16 weeks.
Measured: at 16 weeks
To compare overall survival.
Measured: minimum 1-year follow-up
To compare number of Grade 3/4 Adverse Events
Participants will be followed for the duration of chemotherapy. CTCAE version 4.0
Measured: average up to 1 year
To assess biomarker
Measured: minimum 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionAug 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Jin Soo Lee, National Cancer Center, Korea
- Investigators
- Jin Soo Lee, M.D. PhD., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502202
- Sponsor's protocol ID
- NCCCTS-11-581
- Status last verified
- Jun 2012
- First submitted
- 22 Dec 2011
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01502202
- Acronym / sponsor ID
- NCCCTS-11-581
- Conditions
- Non Small Cell Lung Cancer, Adenocarcinoma
- Keywords
- lung adenocarcinoma, never smoker, 1st line treatment, Intercalation administration, Gefitinib, never smokers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- AstraZeneca
- Study start
- Mar 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Active comparator | Drug: Gefitinib, Drug: Pemetrexed plusCIsplatinPemetrexed plus Cisplatin plus Gefitinib |
| Placebo arm | Placebo comparator | Drug: Placebo, Drug: Pemetrexed plusCIsplatinPemetrexed plus Cisplatin plus Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefitinibAlso: AP-GGefitinib 250mg, per PO. daily, D 5-18 (during 14 days) | Drug | Study arm |
| PlaceboAlso: AP-PPlacebo 1 tablet, per PO, Daily on D 5-18 (during 14 days) | Drug | Placebo arm |
| Pemetrexed plusCIsplatinAlso: Standard chemotherapyPemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles | Drug | Placebo arm, Study arm |
Primary outcome
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.
6 secondary outcomes
To compare objective response rate (CR+PR)
Time frame: minimum 1-year follow-up
To compare duration of response.
Time frame: minimum 1-year follow-up
To compare non progression rate (CR+PR+SD) at 16 weeks.
Time frame: at 16 weeks
To compare overall survival.
Time frame: minimum 1-year follow-up
To compare number of Grade 3/4 Adverse Events
Time frame: average up to 1 year
To assess biomarker
Time frame: minimum 1-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Soo Lee, M.D. PhD. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib and Pemetrexed plusCIsplatin in people with Non Small Cell Lung Cancer and Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Soo Lee, M.D. PhD. (+82-31-920-1501, jslee@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare progression-free survival (time frame: minimum 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.