NSCLC Stage IIPhase 2NCT01470716
Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
A Phase 2 study testing Erlotinib in people with NSCLC Stage II and NSCLC, Stage IIIA, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage II, NSCLC, Stage IIIA
- What is being tested?
- Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to 30 Jun 2022
- 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
- Pathologically confirmed stage II \& IIIA non-small cell lung cancer
- EGFR exon 19 or 21 mutations
- Age ≥ 18 years and ECOG performance 0~1
- Has measurable lesion by RECIST 1.1
- No previous chemotherapy or radiation therapy
- Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr < 1 x UNL or creatinine clearance > 60 ml/min, Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL
- Written informed consent form
Who cannot join
- Previous chemotherapy or radiation therapy
- Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
- Known allergic history of erlotinib
- Interstitial lung disease or fibrosis on chest radiogram
- Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Read the detailed description
Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at diagnosis. However, even patients with resectable disease have poor survival. The need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The presence of somatic mutations in the kinase domain of EGFR strongly correlates with increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC significantly improved response rate and progression-free survival (PFS) compared to platinum-based chemotherapy. These findings prompted this phase II trial of preoperative Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.
- Conditions
- NSCLC Stage II, NSCLC, Stage IIIA
- Being tested
- Erlotinib
- Keywords
- EGFR mutation, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called treatment arm
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Neo-adjuvant Erlotinib treatment arm. Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free survival
Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
Measured: every 8 week
Secondary outcomes (3)
Response rate
The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria 1.1
Measured: every 4 weeks
Overall Survival Rate
Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen )
Measured: every 3months, until death
Toxicity profile
Safety will be evaluated by the frequency, severity, and relationship of adverse event graded by NCI Common Toxicity Criteria version 4.0 that occur during the treatment and follow up periods.
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJan 2012
- Primary completion31 Dec 2021
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Ji-youn Han, National Cancer Center, Korea
- Investigators
- Ji-Youn Han, M.D. PhD., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470716
- Sponsor's protocol ID
- NCCCTS-11-561
- Status last verified
- Apr 2022
- First submitted
- 4 Nov 2011
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
- ClinicalTrials.gov ID
- NCT01470716
- Acronym / sponsor ID
- NCCCTS-11-561
- Conditions
- NSCLC Stage II, NSCLC, Stage IIIA
- Keywords
- EGFR mutation, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Hoffmann-La Roche
- Study start
- Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Nov 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.
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Detailed description
Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at diagnosis. However, even patients with resectable disease have poor survival. The need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The presence of somatic mutations in the kinase domain of EGFR strongly correlates with increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC significantly improved response rate and progression-free survival (PFS) compared to platinum-based chemotherapy. These findings prompted this phase II trial of preoperative Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: ErlotinibNeo-adjuvant Erlotinib treatment arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed stage II \& IIIA non-small cell lung cancer
Key exclusion criteria (6 listed)
- Previous chemotherapy or radiation therapy
- Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
- Known allergic history of erlotinib
- Interstitial lung disease or fibrosis on chest radiogram
- Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
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 |
|---|---|---|
| ErlotinibAlso: treatment armNeo-adjuvant Erlotinib treatment during maximum 8 weeks. | Drug | Study arm |
Primary outcome
Progression-Free survival
Time frame: every 8 week
Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
3 secondary outcomes
Response rate
Time frame: every 4 weeks
Overall Survival Rate
Time frame: every 3months, until death
Toxicity profile
Time frame: Every 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
Ji-Youn Han, 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 Erlotinib in people with NSCLC Stage II and NSCLC, Stage IIIA, 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 7 inclusion and 6 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 6 Apr 2022. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free survival (time frame: every 8 week). 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 6 Apr 2022.