Carcinoma, Non-Small-Cell LungPhase 1NCT03580694
Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing REGN4659 and Cemiplimab in people with Carcinoma, Non-Small-Cell Lung, run by Regeneron Pharmaceuticals at 6 sites in United States.
Trial summary
The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase. 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?
- REGN4659 and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Jun 2018to 4 Dec 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
- Patients with histologically or cytologically documented squamous or non-squamous NSCLC with unresectable stage IIIB or stage IV disease
- Combination dose escalation cohorts: Treatment-experienced patients who have received no more than 3 lines of systemic therapy including no more than 2 lines of cytotoxic chemotherapy, and for whom no available therapy has a high probability to convey clinical benefit.
- Dose escalation cohort C: Anti-PD-1/PD-L1 naïve patients who have received 1 to 2 prior lines of cytotoxic chemotherapy including a platinum doublet-containing regimen
- Expansion cohort(s): Anti-PD-1/PD-L1 experienced patients who have progressed while receiving therapy or within 6 months of stopping therapy for stage III or IV disease. Patients must not have permanently discontinued anti-PD-1/PD-L1 therapy due to treatment related AE. Patients must have received one line of anti-PD--1/PD-L1 immunotherapy. Patients may also have received one line of chemotherapy
Who cannot join
- Expansion cohort(s) only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy
- Expansion cohort(s) only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene mutations or ROS1 fusions.
- Radiation therapy within 2 weeks prior to enrollment and not recovered to baseline from any AE due to radiation
- Patients who received prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody
- Previous treatment with idelalisib (ZYDELIG®) at any time
- Note: Other protocol defined inclusion/ exclusion criteria apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Regeneron Investigational Site
Charlotte, North Carolina, 28204
Regeneron Investigational Site
Chicago, Illinois, 60637
Regeneron Investigational Site
Grand Rapids, Michigan, 49546
Regeneron Investigational Site
Nashville, Tennessee, 37203
Regeneron Investigational Site
Oklahoma City, Oklahoma, 73104
Regeneron Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Study of REGN4659 (Anti-CTLA-4 mAb) in Combination With Cemiplimab (Anti-PD-1 mAb) in the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- REGN4659, Cemiplimab
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Anti-PD-1, Anti-CTLA-4, Immunotherapy
- 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.
REGN4659Drug
REGN4659 will be administered by intravenous (IV) infusion.
CemiplimabDrug
Also called REGN2810
Cemiplimab will be administered by intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab Monotherapy | Experimental | In a single dose escalation cohort, participants will receive cemiplimab alone. Receives: Drug: Cemiplimab |
| Combination Therapy | Experimental | Dose Escalation cohorts:
In 3 dose escalation cohorts, participants will receive a lead-in dose of REGN4659 followed by REGN4659 and cemiplimab in combination.
In 4 dose escalation cohorts, participants will receive REGN4659 with cemiplimab in combination.
Dose Expansion cohorts:
In dose expansion cohorts, participants will receive combination regimens of REGN4659 and cemiplimab. Receives: Drug: REGN4659; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose limiting toxicities (DLTs) during the dose escalation phase
Measured: Up to week 126
Rate of treatment emergent adverse events (TEAEs)
Measured: Up to week 126
Rate of immune-related adverse events (irAEs)
Measured: Up to week 126
Rate of serious adverse events (SAEs)
Measured: Up to week 126
Rate of deaths
Measured: Up to week 126
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Measured: Up to week 126
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during the dose expansion phase
Measured: Up to week 126
REGN4659 and cemiplimab concentrations in serum over time
Measured: Up to week 126
Secondary outcomes (8)
ORR based on RECIST 1.1 during the dose escalation phase
Measured: Up to week 126
ORR based on immune-based therapy Response Evaluation Criteria (iRECIST)
Measured: Up to week 126
Best overall response (BOR)
Measured: Up to week 126
Duration of response (DOR)
Measured: Up to week 126
Disease control rate
Measured: Up to week 126
Progression-free-survival (PFS) based on RECIST 1.1
Measured: Up to week 126
PFS based on iRECIST
Measured: Up to week 126
Overall survival (OS)
Measured: Up to week 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start27 Jun 2018
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Why it stopped: Program reprioritization
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.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580694
- Sponsor's protocol ID
- R4659-ONC-1795
- Status last verified
- Mar 2020
- First submitted
- 26 Jun 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of REGN4659 (Anti-CTLA-4 mAb) in Combination With Cemiplimab (Anti-PD-1 mAb) in the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03580694
- Acronym / sponsor ID
- R4659-ONC-1795
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Anti-PD-1, Anti-CTLA-4, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program reprioritization
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 9 Jul 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.
The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab Monotherapy | Experimental | Drug: CemiplimabIn a single dose escalation cohort, participants will receive cemiplimab alone. |
| Combination Therapy | Experimental | Drug: REGN4659, Drug: CemiplimabDose Escalation cohorts: In 3 dose escalation cohorts, participants will receive a lead-in dose of REGN4659 followed by REGN4659 and cemiplimab in combination. In 4 dose escalation cohorts, participants will receive REGN4659 with cemiplimab in combination. Dose Expansion cohorts: In dose expansion cohorts, participants will receive combination regimens of REGN4659 and cemiplimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically or cytologically documented squamous or non-squamous NSCLC with unresectable stage IIIB or stage IV disease
- Combination dose escalation cohorts: Treatment-experienced patients who have received no more than 3 lines of systemic therapy including no more than 2 lines of cytotoxic chemotherapy, and for whom no available therapy has a high probability to convey clinical benefit.
- Dose escalation cohort C: Anti-PD-1/PD-L1 naïve patients who have received 1 to 2 prior lines of cytotoxic chemotherapy including a platinum doublet-containing regimen
- Expansion cohort(s): Anti-PD-1/PD-L1 experienced patients who have progressed while receiving therapy or within 6 months of stopping therapy for stage III or IV disease. Patients must not have permanently discontinued anti-PD-1/PD-L1 therapy due to treatment related AE. Patients must have received one line of anti-PD--1/PD-L1 immunotherapy. Patients may also have received one line of chemotherapy
Key exclusion criteria (7 listed)
- Expansion cohort(s) only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy
- Expansion cohort(s) only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene mutations or ROS1 fusions.
- Radiation therapy within 2 weeks prior to enrollment and not recovered to baseline from any AE due to radiation
- Patients who received prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody
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 |
|---|---|---|
| REGN4659REGN4659 will be administered by intravenous (IV) infusion. | Drug | Combination Therapy |
| CemiplimabAlso: REGN2810Cemiplimab will be administered by intravenous (IV) infusion. | Drug | Cemiplimab Monotherapy, Combination Therapy |
Primary outcome
Rate of dose limiting toxicities (DLTs) during the dose escalation phase
Time frame: Up to week 126
Rate of treatment emergent adverse events (TEAEs)
Time frame: Up to week 126
Rate of immune-related adverse events (irAEs)
Time frame: Up to week 126
Rate of serious adverse events (SAEs)
Time frame: Up to week 126
Rate of deaths
Time frame: Up to week 126
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Time frame: Up to week 126
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during the dose expansion phase
Time frame: Up to week 126
REGN4659 and cemiplimab concentrations in serum over time
Time frame: Up to week 126
8 secondary outcomes
ORR based on RECIST 1.1 during the dose escalation phase
Time frame: Up to week 126
ORR based on immune-based therapy Response Evaluation Criteria (iRECIST)
Time frame: Up to week 126
Best overall response (BOR)
Time frame: Up to week 126
Duration of response (DOR)
Time frame: Up to week 126
Disease control rate
Time frame: Up to week 126
Progression-free-survival (PFS) based on RECIST 1.1
Time frame: Up to week 126
PFS based on iRECIST
Time frame: Up to week 126
Overall survival (OS)
Time frame: Up to week 126
Results and safety
The study was stopped early (reason given: Program reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
6 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 REGN4659 and Cemiplimab in people with Carcinoma, Non-Small-Cell Lung, run by Regeneron Pharmaceuticals at 6 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 4 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: stopped early, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study was stopped early (reason given: Program reprioritization). 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?
Rate of dose limiting toxicities (DLTs) during the dose escalation phase (time frame: Up to week 126). The study lists 8 primary outcomes in all. 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 Mar 2020.