Non-Small Cell Lung CancerPhase 1NCT05911308
Abequolixron (RGX-104) and Durvalumab in Lung Cancer
A Phase 1 study testing Durvalumab, Carboplatin and Abequolixron in people with Non-Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Non-Small Cell Lung Cancer (NSCLC) is one of the deadliest types of cancer. In lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. 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?
- Durvalumab, Carboplatin and Abequolixron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 27 Feb 2025
- 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
- Willing and able to provide written informed consent obtained to participate in the study and
- HIPAA authorization for the release of personal health information.
- Age ≥ 18 years at the time of consent.
- Histologically or cytologically confirmed non-small cell lung cancer for which surgical resection
- would be standard of care.
- ECOG Performance Status of 0-1
- Body weight of > 40 kg
- Is able to swallow and retain oral medication.
Who cannot join
- Participation in another clinical study with an investigational product during the last 3 weeks
- Concurrent enrollment in another clinical study unless it is an observational (non-interventional)
- clinical study or during the follow-up period of an interventional study.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment with the
- exception of those mentioned in this protocol. Concurrent use of hormonal therapy for noncancer-
- related conditions (e.g., hormone replacement therapy) is acceptable.
- Lack of full recovery from a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- History of allogenic organ transplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27516
About this study
Official title: A Pilot Window of Opportunity Study Evaluating Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy Followed by Evaluation of Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy and Abequolixron (RGX-104) in Non-small Cell Lung Cancer
Non-Small Cell Lung Cancer (NSCLC) is one of the deadliest types of cancer. In lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. Neoadjuvant therapy may have advantages such as, it may be more tolerable prior to surgery, earlier treatment may be more efficacious, and it can provide an indication of treatment response. Neoadjuvant treatment can provide pre- and post-treatment specimens for correlative analysis to better understand mechanisms of action and resistance.
This pilot study will investigate the effects of neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist, in subjects with NSCLC who are scheduled to undergo surgical resection as part of their standard of care.
The purpose of this study is to study how well using a combination of durvalumab, platinum doublet chemotherapy (carboplatin/abraxane or carboplatin/pemetrexed), and abequolixron treats non-small cell lung cancer before surgery. Durvalumab (a type of immunotherapy) and platinum doublet chemotherapy are drugs that are individually approved for use during the treatment of cancer. FDA (Food and Drug Administration) has not approved the combined use of these drugs in treating non-small cell lung cancer. Abequolixron is not FDA approved for the treatment of cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Durvalumab, Carboplatin, Abequolixron, Abraxane, Pemetrexed
- Keywords
- Neoadjuvant therapy, abequolixron (RGX-104), LXR/ApoE, carboplatin, abraxane, pemetrexed
- 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.
DurvalumabDrug
Also called Imfinzi
1,500 mg Durvalumab IV infusion will be given on day 1 of each cycle for 3 cycles.
CarboplatinDrug
Also called Paraplatin
Carboplatin IV infusion will be given on day 1 of each cycle for 3 cycles. The dose will be AUC 5.
AbequolixronDrug
Also called RGX 104, RGX-104, RGX104, SB-742881
100 or 120 mg Abequolixron will be administered by mouth twice a day for 5 days followed by 2 days off throughout your treatment (5 days a week for up to 9 weeks).
AbraxaneDrug
Also called Paclitaxel albumin-bound, Nab-paclitaxel
100 mg/m2 Abraxane will be given by IV infusion on days 1, 8, and 15 of each cycle for 3 cycles.
PemetrexedDrug
Also called Alimta
500 mg/m2 pemetrexed will be given by IV infusion on day 1 of each cycle for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy | Experimental | Subjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist. Receives: Drug: Durvalumab; Drug: Carboplatin; Drug: Abequolixron; Drug: Abraxane; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of surgery
Feasibility will be evaluated as the delay time between the completion of neoadjuvant therapy and surgery. A failure of feasibility will be defined as a delay in the planned surgery of more than 42 days (surgical delay of 35 days, plus 7 days for scheduling).
Measured: Up to 120 days
Secondary outcomes (11)
Toxicities
Toxicities related to study treatment therapy will be classified and graded according to The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0).
NCI-CTCAE v5.0 is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: Up to 1 years after surgery
Major pathologic response rate - squamous histology
Major pathologic complete response rate after neoadjuvant chemotherapy will be assessed via surgical pathology report in subjects with non-small cell lung carcinoma - squamous histology.
Major pathologic response is defined as equal to or less than 10% residual tumor following neoadjuvant therapy.
Measured: Up to 120 days
Major pathologic response rate - non squamous histology
Major pathologic complete response rate after neoadjuvant chemotherapy will be assessed via surgical pathology report in subjects with non-small cell lung carcinoma - nonsquamous histology.
Major pathologic response is defined as equal to or less than 10% residual tumor following neoadjuvant therapy.
Measured: Up to 120 days
Pathologic complete response rate (PCR) -durvalumab in combination with platinum doublet chemotherapy
PCR -durvalumab in combination with platinum doublet chemotherapy will be histologically evaluated at the time of surgery, in subjects receiving neoadjuvant treatment with durvalumab in combination with platinum doublet chemotherapy.
Pathologic complete response (pCR) is the disappearance of all signs of cancer in tissue samples removed during surgery or biopsy (pT0). Also called pathologic complete remission. Pathologic Partial Response (pPR), is the presence of only non-invasive cancer in tissue samples (<pT2)
Measured: Up to 120 days
Pathologic complete response rate (PCR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
Pathologic complete response rate (PCR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron will be histologically evaluated at the time of surgery, in subjects receiving neoadjuvant treatment with durvalumab in combination with platinum doublet chemotherapy plus abequolixron.
Pathologic complete response (pCR) is the disappearance of all signs of cancer in tissue samples removed during surgery or biopsy (pT0). Also called pathologic complete remission. Pathologic Partial Response (pPR), is the presence of only non-invasive cancer in tissue samples (<pT2)
Measured: Up to 120 days
Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy
CRR is defined as the clinical response rate is the combination of complete response (CR) + partial response (PR) defined by The overall response rate will be assessed per Response Evaluation Criteria Solid Tumors (RECIST) 1.1 in subjects receiving durvalumab in combination with platinum doublet chemotherapy.
Based on RECIST v1.1, Complete Response (CR) is the Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Overall Response Rate (ORR) = CR + PR/total number of subjects.
Measured: Up to 1 years after surgery
Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
CRR is defined as the clinical response rate is the combination of complete response (CR) + partial response (PR) defined by The overall response rate will be assessed per Response Evaluation Criteria Solid Tumors (RECIST) 1.1 in subjects receiving durvalumab in combination with platinum doublet chemotherapy plus abequolixron.
Based on RECIST v1.1, Complete Response (CR) is the Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Overall Response Rate (ORR) = CR + PR/total number of subjects.
Measured: Up to 1 years after surgery
Recurrence-free survival (RFS) - durvalumab in combination with platinum doublet chemotherapy
RFS - durvalumab in combination with platinum doublet chemotherapy will be defined as the time from the time after surgery to disease recurrence or death (whichever occurs first) and will be defined by RECIST 1.1. in subjects receiving neoadjuvant therapy with durvalumab in combination with platinum doublet chemotherapy.
Based on RECIST v1.1 Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 5 years
Recurrence-free survival (RFS)- durvalumab in combination with platinum doublet chemotherapy plus abequolixron
RFS - durvalumab in combination with platinum doublet chemotherapy will be defined as the time from the time after surgery to disease recurrence or death (whichever occurs first) and will be defined by RECIST 1.1. in subjects receiving neoadjuvant therapy with durvalumab in combination with platinum doublet chemotherapy plus abequolixron
Based on RECIST v1.1 Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 5 years
Overall Survival (OS) - durvalumab
OS - durvalumab is defined as the time from the first day of study therapy to the date of death for any cause, in subjects receiving neoadjuvant therapy with durvalumab in combination with platinum doublet chemotherapy.
Measured: Up to 5 years
Overall Survival (OS) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
OS - durvalumab in combination with platinum doublet chemotherapy plus abequolixron is defined as the time from the first day of study therapy to date of death for any cause, in subjects receiving neoadjuvant therapy with durvalumab in combination with platinum doublet chemotherapy plus abequolixron.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Apr 2024
- Primary completion4 Oct 2024
- Study completion27 Feb 2025
Why it stopped: Sponsor is closing the trial.
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.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Rgenix, Inc.
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911308
- Sponsor's protocol ID
- LCCC2113
- Status last verified
- Mar 2025
- First submitted
- 9 Jun 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Window of Opportunity Study Evaluating Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy Followed by Evaluation of Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy and Abequolixron (RGX-104) in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05911308
- Acronym / sponsor ID
- LCCC2113
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Neoadjuvant therapy, abequolixron (RGX-104), LXR/ApoE, carboplatin, abraxane, pemetrexed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor is closing the trial.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, Rgenix, Inc.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 22 Jun 2023 (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.
Non-Small Cell Lung Cancer (NSCLC) is one of the deadliest types of cancer. In lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. Neoadjuvant therapy may have advantages such as, it may be more tolerable prior to surgery, earlier treatment may be more efficacious, and it can provide an indication of treatment response. Neoadjuvant treatment can provide pre- and post-treatment specimens for correlative analysis to better understand mechanisms of action and resistance.
This pilot study will investigate the effects of neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist, in subjects with NSCLC who are scheduled to undergo surgical resection as part of their standard of care.
The purpose of this study is to study how well using a combination of durvalumab, platinum doublet chemotherapy (carboplatin/abraxane or carboplatin/pemetrexed), and abequolixron treats non-small cell lung cancer before surgery. Durvalumab (a type of immunotherapy) and platinum doublet chemotherapy are drugs that are individually approved for use during the treatment of cancer. FDA (Food and Drug Administration) has not approved the combined use of these drugs in treating non-small cell lung cancer. Abequolixron is not FDA approved for the treatment of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy | Experimental | Drug: Durvalumab, Drug: Carboplatin, Drug: Abequolixron, Drug: Abraxane, Drug: PemetrexedSubjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide written informed consent obtained to participate in the study and
- HIPAA authorization for the release of personal health information.
- Age ≥ 18 years at the time of consent.
- Histologically or cytologically confirmed non-small cell lung cancer for which surgical resection
- would be standard of care.
Key exclusion criteria (8 listed)
- Participation in another clinical study with an investigational product during the last 3 weeks
- Concurrent enrollment in another clinical study unless it is an observational (non-interventional)
- clinical study or during the follow-up period of an interventional study.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment with the
- exception of those mentioned in this protocol. Concurrent use of hormonal therapy for noncancer-
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 |
|---|---|---|
| DurvalumabAlso: Imfinzi1,500 mg Durvalumab IV infusion will be given on day 1 of each cycle for 3 cycles. | Drug | Neoadjuvant therapy |
| CarboplatinAlso: ParaplatinCarboplatin IV infusion will be given on day 1 of each cycle for 3 cycles. The dose will be AUC 5. | Drug | Neoadjuvant therapy |
| AbequolixronAlso: RGX 104, RGX-104, RGX104, SB-742881100 or 120 mg Abequolixron will be administered by mouth twice a day for 5 days followed by 2 days off throughout your treatment (5 days a week for up to 9 weeks). | Drug | Neoadjuvant therapy |
| AbraxaneAlso: Paclitaxel albumin-bound, Nab-paclitaxel100 mg/m2 Abraxane will be given by IV infusion on days 1, 8, and 15 of each cycle for 3 cycles. | Drug | Neoadjuvant therapy |
| PemetrexedAlso: Alimta500 mg/m2 pemetrexed will be given by IV infusion on day 1 of each cycle for 3 cycles. | Drug | Neoadjuvant therapy |
Primary outcome
Feasibility of surgery
Time frame: Up to 120 days
Feasibility will be evaluated as the delay time between the completion of neoadjuvant therapy and surgery. A failure of feasibility will be defined as a delay in the planned surgery of more than 42 days (surgical delay of 35 days, plus 7 days for scheduling).
11 secondary outcomes
Toxicities
Time frame: Up to 1 years after surgery
Major pathologic response rate - squamous histology
Time frame: Up to 120 days
Major pathologic response rate - non squamous histology
Time frame: Up to 120 days
Pathologic complete response rate (PCR) -durvalumab in combination with platinum doublet chemotherapy
Time frame: Up to 120 days
Pathologic complete response rate (PCR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
Time frame: Up to 120 days
Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy
Time frame: Up to 1 years after surgery
Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
Time frame: Up to 1 years after surgery
Recurrence-free survival (RFS) - durvalumab in combination with platinum doublet chemotherapy
Time frame: Up to 5 years
Recurrence-free survival (RFS)- durvalumab in combination with platinum doublet chemotherapy plus abequolixron
Time frame: Up to 5 years
Overall Survival (OS) - durvalumab
Time frame: Up to 5 years
Overall Survival (OS) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: Sponsor is closing the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jared Weiss, MD principal investigator
UNC Lineberger Comprehensive 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 1 study testing Durvalumab, Carboplatin and Abequolixron in people with Non-Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 8 inclusion and 8 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 21 Mar 2025. 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 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: Sponsor is closing the trial.). 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?
Feasibility of surgery (time frame: Up to 120 days). 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 21 Mar 2025.