Advanced Non-small Cell Lung CancerPhase 2NCT04699123

The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer

A Phase 2 study testing NC318 800 mg, NC318 400 mg and Pembrolizumab in people with Advanced Non-small Cell Lung Cancer, run by Yale University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This is a phase 2 study to investigate NC318 alone or in combination with Pembrolizumab in patients with advanced non-small cell lung cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Non-small Cell Lung Cancer
What is being tested?: NC318 800 mg, NC318 400 mg and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2021to 30 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

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

Histologically or cytologically documented, locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the American Joint Committee /AJCC staging system)
ECOG performance status of 0 to 1
Measurable disease per RECIST v1.1 criteria
Arm 1a, and 1b and 1c: Prior PD-1 axis inhibitor therapy (anti-PD-1 or anti-PD-L1, e.g. nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab) either alone or in combination with other systemic agents, with documented progressive disease.
Arm 2a: PD-L1 expression of less than 50 percent (PD-1 axis inhibitor therapy naïve)
Patients with NSCLC known to harbor an ALK rearrangement, ROS1 rearrangement, EGFR mutation or BRAF mutation known to be sensitive to FDA approved tyrosine kinase inhibitors (TKI), are only eligible after experiencing disease progression (during or after treatment) or intolerance to respective TKI:

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Patients with TKI treated EGFR mutant NSCLC harboring the secondary EGFR T790M tumor must have received prior osimertinib.
Patients with crizotinib treated ALK rearranged NSCLC must have received a next generation ALK inhibitor (e.g. ceritinib, alectinib, brigatinib or lorlatinib).
At least one tumor amenable to incisional, excisional, core or forceps (transbronchial) biopsy. Patients must be willing to undergo a tumor biopsy before starting trial therapy and at the time of disease progression.
Adequate hematologic and end-organ function

Who cannot join

Subjects must not have a history of life-threatening toxicity related to prior anti-PD-1 axis therapy:
Subjects with history of anti-PD-1 axis therapy toxicities that are unlikely to recur with standard countermeasures (e.g., hormone replacement after adrenal crisis) are eligible.
Symptomatic or untreated CNS metastases. Patients with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy
No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose are allowed.
Completed stereotactic radiosurgery at least 1 week prior to initiation of trial therapyCycle 1, Day 1 or whole-brain radiation at least 2 weeks prior to initiation of trial therapyCycle 1, Day 1.

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History of leptomeningeal carcinomatosis
Prior palliative radiotherapy outside the CNS within 2 weeks of the first dose of study drug
Treatment with systemic immunosuppressive medications (including but not limited to, dexamethasone at doses > 2 mg daily (or equivalent dose of other corticosteroids), cyclophosphamide, tacrolimus, sirolimus, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [anti-TNF] agents) within 2 weeks prior to initiating trial therapy. (Inhaled or topically applied steroids, and acute and chronic standard-dose NSAIDs are permitted. Replacement steroids are also permitted). Prophylactic corticosteroids prior to imaging with intravenous contrast are allowed per institutional guidelines, without need for delay of 2 weeks. Arm 2a: No prior PD-1 axis inhibitor therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University
New Haven, Connecticut, 06492

Other trials in United States

About this study

This is a phase 2 study to investigate NC318 alone or in combination with Pembrolizumab in patients with advanced non-small cell lung cancer.

Read the detailed description

This is a non-randomized, three-arm trial.

Arm 1a and 1b will enroll patients with advanced NSCLC regardless of tumor PD-L1 expression who have experienced disease progression on or after PD-1 axis inhibitor therapy, given alone or in combination with other systemic anti-cancer therapy. Patients will be assigned to arm 1a or 1b at the discretion of the treating physician. Patients on arm 1a will receive NC318 alone; those on arm 1b, combination therapy with NC318 and pembrolizumab.

Arm 1a will be based on a Simon two-stage minimax design. In the first stage, 18 patients will be accrued. If tumor response per RECIST v1.1 is achieved in 2 or fewer patients, arm 1a will be closed to further enrollment. If tumor response is demonstrated in 3 or more patients, then 25 additional patients will be accrued (stage 2), for a total of 43 patients.

Arm 1a and 1b will start with a safety run-in portion consisting of 6 patients (see 4.1.1). If deemed safe, each arm will continue to accrue and follow the Simon two-stage design outlined above. Patients in the run-in portion will be included in stage 1 of the Simon two-stage design.

Arm 2 will enroll patients with advanced NSCLC and tumor PD-L1 expression less than 50% who are naïve to PD-1 axis inhibitor therapy. Patients on arm 2 will receive combination therapy with NC318 and pembrolizumab. Arm 2 will also start with a safety run-in portion identical to that of arms 1a and 1b (see 4.1.1). If deemed safe, accrual will continue following a Simon two-stage minimax design. In the first stage, 19 patients will be accrued. If tumor response per RECIST v1.1 is achieved in 3 or fewer patients, arm 2 will be closed to further enrollment. If tumor response is demonstrated in 4 or more patients, then 36 additional patients will be accrued (stage 2), for a total of 54 patients. Patients in the run-in portion will be included in stage 1 of the Simon two-stage design.

The study protocol was amended to add 2 additional arms 5/2023. Arms 1c and 2a will receive NC318 800 mg, IV weekly for 8 doses, followed by every 2 week dosing. They both follow the same procedures as the earlier arms in the study. Arm 2 has essentially been removed from the study- but remains included in the protocol registration.

In addition, patients treated on arm 1a will be allowed to receive combination therapy with NC318 and pembrolizumab at the time of progression, after a mandatory tumor biopsy. They will be considered separately from arm 1c.

Conditions: Advanced Non-small Cell Lung Cancer
Being tested: NC318 800 mg, NC318 400 mg, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NC318 800 mgDrug
NC318 will be given intravenously (IV) weekly for 8 doses and then every 2 weeks for patients receiving combination therapy treatment or weekly for patient receiving NC318 in monotherapy.
NC318 400 mgDrug
NC318 will be given intravenously (IV) every 2 weeks.
PembrolizumabDrug
Pembrolizumab 200 mg will be given IV every 3 weeks

Study groups in NCT04699123
Study group	Role	What they receive
Arm 1a - NC318 only	Experimental	At the discretion of the treating physician, advanced NSCLC patients on arm 1a will receive NC318 alone. Receives: Drug: NC318 800 mg
Arm 1b - NC318 and Pembrolizumab	Experimental	At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab. Receives: Drug: NC318 400 mg; Drug: Pembrolizumab
Arm 1c - NC318 and Pembrolizumab	Experimental	At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab. Receives: Drug: NC318 800 mg
Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab	Experimental	Arm 2 will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive therapy with NC318 in combination with pembrolizumab. Receives: Drug: NC318 400 mg; Drug: Pembrolizumab
Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab	Experimental	Arm 2a will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive combination therapy with NC318 and pembrolizumab. Receives: Drug: NC318 800 mg; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate (ORR) in Arm 1a
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 in arm 1a
Measured: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
Objective response rate (ORR) in Arm 1b
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
Measured: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
Objective response rate (ORR) in Arm 1c
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
Measured: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
Number of participants on Arm 1b with treatment related adverse events as assessed by CTCAE v5
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
Measured: Safety run in of 6 weeks
Number of participants on Arm 1c with treatment related adverse events as assessed by CTCAE v5
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
Measured: Safety run in of 6 weeks
Objective response rate (ORR) in Arm 2
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
Measured: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
Objective response rate (ORR) in Arm 2a
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
Measured: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
Number of participants in arm 2 with treatment related adverse events as assessed by CTCAE v5
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2
Measured: Safety run in of 6 weeks
Number of participants in arm 2a with treatment related adverse events as assessed by CTCAE v5
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2
Measured: Safety run in of 6 weeks

Secondary outcomes (6)

Progression-free survival (RECIST v1.1) Arm 1a
To determine progression-free survival (RECIST v1.1) with NC318 in patients with pre-treated advanced NSCLC who have experienced disease progression on or after anti-PD-1 axis therapy.
Measured: Until disease progression or death, up to 4 years
Overall Survival (RECIST v1.1) Arm 1a
To determine overall survival with NC318 in patients with pre-treated advanced NSCLC who have experienced disease progression on or after anti-PD-1 axis therapy.
Measured: Until death, up to 5 years
Progression-free survival (RECIST v1.1) Arm 1B
To determine progression-free survival (RECIST v1.1) with NC318 combined with pembrolizumab in patients with pre- treated advanced NSCLC who have experienced disease progression on or after anti-PD-1 axis therapy.
Measured: Until disease progression or death, up to 4 years
Overall survival (RECIST v1.1) Arm 1B
To determine overall survival (RECIST v1.1) with NC318 combined with pembrolizumab in patients with pre- treated advanced NSCLC who have experienced disease progression on or after anti-PD-1 axis therapy.
Measured: Until death, up to 5 years
Progression-free survival (RECIST v1.1) Arm 2
To determine progression-free survival (RECIST v1.1) with NC318 and pembrolizumab when administered in combination to patients with PD-1 inhibitor naïve advanced NSCLC with tumor PD-L1 expression less than 50 percent.
Measured: Until disease progression or death, up to 4 years
Overall survival (RECIST v1.1) Arm 2
To determine overall survival (RECIST v1.1) with NC318 and pembrolizumab when administered in combination to patients with PD-1 inhibitor naïve advanced NSCLC with tumor PD-L1 expression less than 50 percent.
Measured: Until death, 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.

4 Feb 202130 Dec 2026

First posted7 Jan 2021
Study start4 Feb 2021
Primary completion30 Dec 2026 (estimated)
Study completion30 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 159 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04699123
Sponsor's protocol ID: 2000028206
Other IDs: 2P50CA196530-06
Status last verified: Jun 2026
First submitted: 16 Dec 2020
Last updated: 21 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT04699123
Acronym / sponsor ID: 2000028206
Conditions: Advanced Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 159 participants (estimated)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), NextCure, Inc., Merck Sharp & Dohme LLC
Study start: 4 Feb 2021 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Dec 2026 (estimated)
First posted: 7 Jan 2021 (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 2 study to investigate NC318 alone or in combination with Pembrolizumab in patients with advanced non-small cell lung cancer.

Detailed description

This is a non-randomized, three-arm trial.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Arm 1a - NC318 only	Experimental	Drug: NC318 800 mgAt the discretion of the treating physician, advanced NSCLC patients on arm 1a will receive NC318 alone.
Arm 1b - NC318 and Pembrolizumab	Experimental	Drug: NC318 400 mg, Drug: PembrolizumabAt the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab.
Arm 1c - NC318 and Pembrolizumab	Experimental	Drug: NC318 800 mgAt the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab.
Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab	Experimental	Drug: NC318 400 mg, Drug: PembrolizumabArm 2 will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive therapy with NC318 in combination with pembrolizumab.
Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab	Experimental	Drug: NC318 800 mg, Drug: PembrolizumabArm 2a will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive combination therapy with NC318 and pembrolizumab.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histologically or cytologically documented, locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the American Joint Committee /AJCC staging system)
ECOG performance status of 0 to 1
Measurable disease per RECIST v1.1 criteria
Arm 1a, and 1b and 1c: Prior PD-1 axis inhibitor therapy (anti-PD-1 or anti-PD-L1, e.g. nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab) either alone or in combination with other systemic agents, with documented progressive disease.
Arm 2a: PD-L1 expression of less than 50 percent (PD-1 axis inhibitor therapy naïve)

Key exclusion criteria (9 listed)

Subjects must not have a history of life-threatening toxicity related to prior anti-PD-1 axis therapy:
Symptomatic or untreated CNS metastases. Patients with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
History of leptomeningeal carcinomatosis
Prior palliative radiotherapy outside the CNS within 2 weeks of the first dose of study drug
Treatment with systemic immunosuppressive medications (including but not limited to, dexamethasone at doses > 2 mg daily (or equivalent dose of other corticosteroids), cyclophosphamide, tacrolimus, sirolimus, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [anti-TNF] agents) within 2 weeks prior to initiating trial therapy. (Inhaled or topically applied steroids, and acute and chronic standard-dose NSAIDs are permitted. Replacement steroids are also permitted). Prophylactic corticosteroids prior to imaging with intravenous contrast are allowed per institutional guidelines, without need for delay of 2 weeks. Arm 2a: No prior PD-1 axis inhibitor therapy

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
NC318 800 mgNC318 will be given intravenously (IV) weekly for 8 doses and then every 2 weeks for patients receiving combination therapy treatment or weekly for patient receiving NC318 in monotherapy.	Drug	Arm 1a - NC318 only, Arm 1c - NC318 and Pembrolizumab, Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab
NC318 400 mgNC318 will be given intravenously (IV) every 2 weeks.	Drug	Arm 1b - NC318 and Pembrolizumab, Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab
PembrolizumabPembrolizumab 200 mg will be given IV every 3 weeks	Drug	Arm 1b - NC318 and Pembrolizumab, Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab, Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab

Primary outcome

Objective response rate (ORR) in Arm 1a
Time frame: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 in arm 1a
Objective response rate (ORR) in Arm 1b
Time frame: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
Objective response rate (ORR) in Arm 1c
Time frame: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 1b
Number of participants on Arm 1b with treatment related adverse events as assessed by CTCAE v5
Time frame: Safety run in of 6 weeks
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
Number of participants on Arm 1c with treatment related adverse events as assessed by CTCAE v5
Time frame: Safety run in of 6 weeks
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 1b
Objective response rate (ORR) in Arm 2
Time frame: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
Objective response rate (ORR) in Arm 2a
Time frame: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years
To determine the objective response rate (ORR) using RECIST v1.1 to NC318 combined with pembrolizumab in arm 2
Number of participants in arm 2 with treatment related adverse events as assessed by CTCAE v5
Time frame: Safety run in of 6 weeks
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2
Number of participants in arm 2a with treatment related adverse events as assessed by CTCAE v5
Time frame: Safety run in of 6 weeks
To determine the safety of NC318 when administered in combination with pembrolizumab in arm 2

6 secondary outcomes

Progression-free survival (RECIST v1.1) Arm 1a
Time frame: Until disease progression or death, up to 4 years
Overall Survival (RECIST v1.1) Arm 1a
Time frame: Until death, up to 5 years
Progression-free survival (RECIST v1.1) Arm 1B
Time frame: Until disease progression or death, up to 4 years
Overall survival (RECIST v1.1) Arm 1B
Time frame: Until death, up to 5 years
Progression-free survival (RECIST v1.1) Arm 2
Time frame: Until disease progression or death, up to 4 years
Overall survival (RECIST v1.1) Arm 2
Time frame: Until death, up to 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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.

Scott Gettinger principal investigator

Yale University

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 NC318 800 mg, NC318 400 mg and Pembrolizumab in people with Advanced Non-small Cell Lung Cancer, run by Yale University 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Objective response rate (ORR) in Arm 1a (time frame: Tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04699123.

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 Aug 2026.