Non-Small Cell Lung CancerPhase 2NCT02109653
Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
A Phase 2 study testing LGX818 in people with Non-Small Cell Lung Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- LGX818
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Nov 2017
- 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
- Presence of BRAF V600E mutation in tumor tissue
- Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
- At least one measurable lesion as defined by RECIST v1.1
- Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
Who cannot join
- Patients with symptomatic Central Nervous System (CNS) metastases
- History of leptomeningeal metastases
- Prior therapy with a BRAF inhibitor
- Patients taking prohibited medication listed in the protocol
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Pregnant or lactating women or woman of childbearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center SC-2
Chicago, Illinois, 60546
About this study
Official title: A Phase II, Single Arm, Open-label, Multicenter, Study of Oral LGX818 in Patients With BRAF V600 Mutant, Advanced Non-small Cell Lung Cancer (NSCLC) That Have Progressed During or After at Least One Prior Chemotherapy
This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- LGX818
- Keywords
- NSCLC,, Non-Small Cell Lung Cancer,, BRAF V600,, LGX818
- 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.
LGX818Drug
Oral LGX818 300mg daily
| Study group | Role | What they receive |
|---|---|---|
| LGX818 | Experimental | Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy. Receives: Drug: LGX818 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
Measured: up to 24 weeks
Secondary outcomes (8)
Overall Response Rate (ORR)
ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)
Measured: baseline, every 6 weeks up to 24 weeks
Progression-Free Survival (PFS)
PFS determined by investigator and BIRC.
Measured: baseline, every 6 weeks up to 24 weeks
Duration of Response (DOR)
DOR by investigator and BIRC assessments.
Measured: baseline, every 6 weeks up to 24 weeks
Overall survival (OS)
Overall survival (OS)
Measured: baseline, every 6 weeks up to 24 weeks
Safety Profile
Adverse events and laboratory abnormalities
Measured: baseline, every 3 weeks up to 24 weeks
Disease Control Rate (DCR)
DCR by investigator and BIRC assessments.
Measured: baseline, every 6 weeks up to 24 weeks
Pharmacokinetics profile
Plasma concentration-time profiles of encorafenib (LGX818).
Measured: baseline, every 3 weeks up to 18 weeks
Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay
Concordance rate between BRAF mutation status obtained using the investigational diagnostic test and the companion diagnostic assay which will be submitted for Pre-market approval (PMA)
Measured: screening, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJun 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Study never started - transferred to Array.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, 1-800-718-1021
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109653
- Sponsor's protocol ID
- CLGX818A2202
- Other IDs
- 2013-005014-34
- Status last verified
- Nov 2020
- First submitted
- 25 Mar 2014
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Arm, Open-label, Multicenter, Study of Oral LGX818 in Patients With BRAF V600 Mutant, Advanced Non-small Cell Lung Cancer (NSCLC) That Have Progressed During or After at Least One Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT02109653
- Acronym / sponsor ID
- CLGX818A2202
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC,, Non-Small Cell Lung Cancer,, BRAF V600,, LGX818
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started - transferred to Array.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 10 Apr 2014 (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 is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LGX818 | Experimental | Drug: LGX818Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of BRAF V600E mutation in tumor tissue
- Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
- At least one measurable lesion as defined by RECIST v1.1
- Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
Key exclusion criteria (7 listed)
- Patients with symptomatic Central Nervous System (CNS) metastases
- History of leptomeningeal metastases
- Prior therapy with a BRAF inhibitor
- Patients taking prohibited medication listed in the protocol
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
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 |
|---|---|---|
| LGX818Oral LGX818 300mg daily | Drug | LGX818 |
Primary outcome
Overall Response Rate (ORR)
Time frame: up to 24 weeks
ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
8 secondary outcomes
Overall Response Rate (ORR)
Time frame: baseline, every 6 weeks up to 24 weeks
Progression-Free Survival (PFS)
Time frame: baseline, every 6 weeks up to 24 weeks
Duration of Response (DOR)
Time frame: baseline, every 6 weeks up to 24 weeks
Overall survival (OS)
Time frame: baseline, every 6 weeks up to 24 weeks
Safety Profile
Time frame: baseline, every 3 weeks up to 24 weeks
Disease Control Rate (DCR)
Time frame: baseline, every 6 weeks up to 24 weeks
Pharmacokinetics profile
Time frame: baseline, every 3 weeks up to 18 weeks
Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay
Time frame: screening, up to 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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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.
Pfizer CT.gov Call Center study director
1-800-718-1021
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 LGX818 in people with Non-Small Cell Lung Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 1 site 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?
The sponsor lists 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Nov 2020. 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 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Response Rate (ORR) (time frame: up to 24 weeks). 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 Nov 2020.