Non-small Cell Lung CancerPhase 1NCT03396497
Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer
A Phase 1 study testing LYC-55716 and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Lycera Corp. at 4 sites in United States.
Trial summary
This is a Phase 1B study designed to assess the safety and tolerability of LYC-55716 given in combination with pembrolizumab to subjects with metastatic NSCLC, and to assess the combination for biologic and clinical activity in 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?
- LYC-55716 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Aug 2018to 20 Oct 2019
- Phase
- Phase 1
- 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
- Subject has histologic or cytologic confirmation of metastatic NSCLC. Subjects must have a TPS score available as determined by an FDA approved test. Subject has stable disease or disease progression and is being treated with pembrolizumab therapy as standard of care by the Investigator.
- Subject is male or female and at least 18 years of age.
- Subject has at least 1 measurable lesion per RECIST v1.1 criteria by computed tomography (CT) scan or magnetic resonance image (MRI).
- Subject provides consent for fresh paired tumor biopsy samples to be obtained at screening and after 4 weeks of treatment (not required for run-in cohort or expansion of run-in cohort).
- Subject has a life expectancy of at least 12 weeks
- Subject has adequate organ function as determined by the following laboratory values:
Show all 16Show fewer
- ANC* ≥ 1500/mm³ (≥ 1.5 x 10^9/L)
- Platelets* ≥ 100,000/mm³ (≥ 100 x 10^9/L)
- Lymphocytes* ≥ 500/mm³ (≥ 0.5 x 10^9/L)
- Hemoglobin* ≥ 9.0 g/dL
- Serum Creatinine or Creatinine Clearance** ≤ 1.5 x ULN, > 50 mL/min
- Total Serum Bilirubin ≤ 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)
- Liver Transaminases (ALT/AST) ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver metastases present
- (* = without ongoing growth factor or transfusion support)
- (** = calculated by Cockcroft and Gault's formula)
- (ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit of normal)
Who cannot join
- Subjects may not have genomic aberrations such as ALK, EGFR, or BRAF for which there are FDA-approved targeted therapies available. Subjects may not have ROS1 aberration in accordance with the pembrolizumab label.
- Subject has received an investigational drug in the 28 day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.
- Subject has known symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Subjects with stable asymptomatic brain metastases or leptomeningeal disease are eligible provided that they have not required new treatments for this disease in a 28 day period before the first dose of study drug, and anticonvulsants and steroids have not been administered for a period of 2 weeks prior to the first dose of study drug.
- Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to CTCAE Grade 2 or better.
- Subject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lycera Investigational Site
Ann Arbor, Michigan, 48109
Lycera Investigational Site
Aurora, Colorado, 80045
Lycera Investigational Site
Nashville, Tennessee, 37203
Lycera Investigational Site
Seattle, Washington, 98109
About this study
Official title: A Multicenter, Open-Label Study of LYC-55716 in Combination With Pembrolizumab in Adult Subjects With Metastatic Non-Small Cell Lung Cancer
This is a Phase 1B study designed to assess the safety and tolerability of LYC-55716 given in combination with pembrolizumab to subjects with metastatic NSCLC, and to assess the combination for biologic and clinical activity in NSCLC.
Read the detailed description
Approximately 18 subjects across 5 US sites will be enrolled in the study.
Subjects will enter a screening period of up to 28 days, followed by continuous twice daily administration of LYC-55716 in 28 day treatment cycles. Subjects will also be administered pembrolizumab every 3 weeks as prescribed as standard of care by the Investigator in accordance with the package insert.
The study will begin with a run-in cohort of 3 subjects to assess the safety and tolerability of the LYC-55716/pembrolizumab combination. Subjects in the run-in cohort will be enrolled singly at intervals of not less than 7 days in order to monitor for adverse reactions to the combination. If no subjects in the run-in cohorts has a DLT, then the study may proceed to the main cohort (15 subjects).
Subjects will receive combination treatment until clinically significant disease progression or unacceptable toxicity, or up to a maximum of 24 months.
Primary Study Objectives:
Run-in Cohort
- Evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination
- Determine the dose of LYC-55716 that is adequately tolerated when used in combination with pembrolizumab
Main Study Cohort
- Further evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination
Secondary Study Objectives:
Main Study Cohort
- Evaluate the cellular immune response in paired tumor biopsy samples
- Evaluate effects on circulating biomarkers in the blood of LYC-55716 with pembrolizumab
- Determine the objective response rate
- Determine the duration of response
- Determine the progression-free survival (PFS) and overall survival (OS)
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- LYC-55716, Pembrolizumab
- 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.
LYC-55716Drug
Continuous twice daily administration of LYC-55716 in 28 day treatment cycles.
PembrolizumabDrug
Pembrolizumab administered every 3 weeks as prescribed as standard of care by the investigator in accordance with the package insert.
| Study group | Role | What they receive |
|---|---|---|
| LYC-55716 + pembrolizumab | Experimental | Subjects will receive combination treatment until disease progression or unacceptable toxicity, or up to a maximum of 24 months. Receives: Drug: LYC-55716; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be assessed by the number of subjects with any treatment-emergent Adverse Events
Common terminology criteria for adverse events (CTCAE) will be used for AE assessment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start3 Aug 2018
- Primary completion20 Oct 2019 (estimated)
- Study completion20 Oct 2019 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lycera Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396497
- Sponsor's protocol ID
- LYC-55716-1002
- Status last verified
- Sep 2019
- First submitted
- 3 Jan 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study of LYC-55716 in Combination With Pembrolizumab in Adult Subjects With Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03396497
- Acronym / sponsor ID
- LYC-55716-1002
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Lycera Corp.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 20 Oct 2019 (estimated)
- First posted
- 11 Jan 2018 (actual)
- 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 a Phase 1B study designed to assess the safety and tolerability of LYC-55716 given in combination with pembrolizumab to subjects with metastatic NSCLC, and to assess the combination for biologic and clinical activity in NSCLC.
Detailed description
Approximately 18 subjects across 5 US sites will be enrolled in the study.
Subjects will enter a screening period of up to 28 days, followed by continuous twice daily administration of LYC-55716 in 28 day treatment cycles. Subjects will also be administered pembrolizumab every 3 weeks as prescribed as standard of care by the Investigator in accordance with the package insert.
The study will begin with a run-in cohort of 3 subjects to assess the safety and tolerability of the LYC-55716/pembrolizumab combination. Subjects in the run-in cohort will be enrolled singly at intervals of not less than 7 days in order to monitor for adverse reactions to the combination. If no subjects in the run-in cohorts has a DLT, then the study may proceed to the main cohort (15 subjects).
Subjects will receive combination treatment until clinically significant disease progression or unacceptable toxicity, or up to a maximum of 24 months.
Primary Study Objectives:
Run-in Cohort
- Evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination
- Determine the dose of LYC-55716 that is adequately tolerated when used in combination with pembrolizumab
Main Study Cohort
- Further evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination
Secondary Study Objectives:
Main Study Cohort
- Evaluate the cellular immune response in paired tumor biopsy samples
- Evaluate effects on circulating biomarkers in the blood of LYC-55716 with pembrolizumab
- Determine the objective response rate
- Determine the duration of response
- Determine the progression-free survival (PFS) and overall survival (OS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LYC-55716 + pembrolizumab | Experimental | Drug: LYC-55716, Drug: PembrolizumabSubjects will receive combination treatment until disease progression or unacceptable toxicity, or up to a maximum of 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject has histologic or cytologic confirmation of metastatic NSCLC. Subjects must have a TPS score available as determined by an FDA approved test. Subject has stable disease or disease progression and is being treated with pembrolizumab therapy as standard of care by the Investigator.
- Subject is male or female and at least 18 years of age.
- Subject has at least 1 measurable lesion per RECIST v1.1 criteria by computed tomography (CT) scan or magnetic resonance image (MRI).
- Subject provides consent for fresh paired tumor biopsy samples to be obtained at screening and after 4 weeks of treatment (not required for run-in cohort or expansion of run-in cohort).
- Subject has a life expectancy of at least 12 weeks
Key exclusion criteria (5 listed)
- Subjects may not have genomic aberrations such as ALK, EGFR, or BRAF for which there are FDA-approved targeted therapies available. Subjects may not have ROS1 aberration in accordance with the pembrolizumab label.
- Subject has received an investigational drug in the 28 day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.
- Subject has known symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Subjects with stable asymptomatic brain metastases or leptomeningeal disease are eligible provided that they have not required new treatments for this disease in a 28 day period before the first dose of study drug, and anticonvulsants and steroids have not been administered for a period of 2 weeks prior to the first dose of study drug.
- Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to CTCAE Grade 2 or better.
- Subject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.
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 |
|---|---|---|
| LYC-55716Continuous twice daily administration of LYC-55716 in 28 day treatment cycles. | Drug | LYC-55716 + pembrolizumab |
| PembrolizumabPembrolizumab administered every 3 weeks as prescribed as standard of care by the investigator in accordance with the package insert. | Drug | LYC-55716 + pembrolizumab |
Primary outcome
Safety and tolerability will be assessed by the number of subjects with any treatment-emergent Adverse Events
Time frame: 12 weeks
Common terminology criteria for adverse events (CTCAE) will be used for AE assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYC-55716 and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Lycera Corp. at 4 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?
The sponsor lists 16 inclusion and 5 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability will be assessed by the number of subjects with any treatment-emergent Adverse Events (time frame: 12 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 25 Sep 2019.