Carcinoma, Non-Small-Cell LungPhase 3NCT01487174
KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
A Phase 3 study testing KD019 and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Kadmon Corporation, LLC at 2 sites in United States.
Trial summary
This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- KD019 and Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Dec 2011to 25 Jul 2013
- Phase
- Phase 3
- 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
For Eligibility subjects must have:
- failed one or two previous courses of therapy.
- have no active brain metastasis. Treated non-active brain metastasis are acceptable.
- cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva [erlotinib] or Iressa [gefitinib]) in the past.
- has demonstrated progressive disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Juan Oncology Associates
Farmington, New Mexico, 87401
Yale Cancer Center
New Haven, Connecticut, 06519
About this study
Official title: A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- KD019, Erlotinib
- 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.
KD019Drug
Also called XL647
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
ErlotinibDrug
Also called Tarceva
Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
| Study group | Role | What they receive |
|---|---|---|
| KD019 | Experimental | KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted. Receives: Drug: KD019 |
| Erlotinib | Active comparator | Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted. Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Secondary outcomes (3)
Progression-free survival
Measured: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Number and type of adverse events related to KD019
For the purpose of data collection, all untoward events that occur after informed consent through 30 days after last dose of study treatment are to be recorded.
Measured: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Objective response rate
Measured: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study start14 Dec 2011
- Primary completion25 Jul 2013
- Study completion25 Jul 2013
Why it stopped: Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487174
- Sponsor's protocol ID
- KD019-301
- Status last verified
- May 2022
- First submitted
- 2 Dec 2011
- Last updated
- 13 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01487174
- Acronym / sponsor ID
- KD019-301
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2011
- Primary completion
- 25 Jul 2013 (actual)
- Study completion
- 25 Jul 2013 (actual)
- First posted
- 7 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.
This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KD019 | Experimental | Drug: KD019KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted. |
| Erlotinib | Active comparator | Drug: ErlotinibErlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| KD019Also: XL647KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted. | Drug | KD019 |
| ErlotinibAlso: TarcevaErlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted. | Drug | Erlotinib |
Primary outcome
Overall survival
Time frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
3 secondary outcomes
Progression-free survival
Time frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Number and type of adverse events related to KD019
Time frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Objective response rate
Time frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Results and safety
The study was stopped early (reason given: Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KD019 and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Kadmon Corporation, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues). 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?
Overall survival (time frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year). 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 13 May 2022.