ClinicalTrials.gg
Not yet recruitingNCT07637513PrE0512Updated Jun 9, 2026

Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

A Phase 3 interventional study of Tarlatamab and Durvalumab in Limited Stage Small-Cell Lung Cancer, sponsored by PrECOG, LLC.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by PrECOG, LLC. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
430
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.

Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.

Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.

The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).

Read the detailed description

The purpose of this trial is to evaluate the clinical efficacy of tarlatamab in combination with durvalumab as consolidation therapy for LS-SCLC after completion of chemotherapy and radiation compared to durvalumab alone. Tarlatamab has demonstrated significant clinical activity against SCLC in the extensive stage setting and demonstrated improved overall survival compared to second line chemotherapy. The durability of response and progression-free survival (PFS) rates are encouraging that this therapy has the ability to achieve more long-term disease control than traditional treatments like chemotherapy and programmed cell death-ligand 1 (PD-L1) immunotherapy alone. Given the high risk of recurrence and death for LS-SCLC, tarlatamab may be an effective strategy to improve the risk of recurrence and death in this earlier disease setting.

Tarlatamab is a bi-specific T-cell engager that targets delta-like ligand 3 (DLL3) and CD3 and was developed with the intent to treat small cell lung cancer due to the high level of expression of DLL3 on the cell surface. The anti-tumor activity of tarlatamab requires simultaneous binding to both target cells and T cells.

RECIST 1.1 criteria will be used for disease response. This is will be measured by the investigators as well as a Blinded Independent Central Review (BICR).

Archived tumor tissue will be requested at baseline for future research. Research peripheral blood samples will be obtained to measure the level of tarlatamab and for future research.

Patient-reported outcomes will also be performed.

02

Conditions studied

  • Limited Stage Small-Cell Lung Cancer

Keywords

  • Tarlatamab
  • Durvalumab
  • Consolidation
  • Small Cell Lung Cancer
03

In context

Small Cell Lung Carcinoma

1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.

This study's planned enrollment of 430 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

PrECOG, LLC. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Patient must have or cytologically confirmed Small Cell Lung Cancer (SCLC).
  • SCLC must be diagnosed as Limited-Stage-SCLC (LS-SCLC) (Stage I-III, disease can be encompassed within a radical radiation portal per investigator assessment) and treated with 3 to 4 cycles of chemotherapy and radiation therapy. Three cycles of chemotherapy will be acceptable if the planned radiation therapy course is completed concurrently with chemotherapy.

    • Patient must not be eligible for surgical resection or have had prior surgical resection for the current diagnosis of LS-SCLC.
    • Small cell carcinoma may not be transformed from previous diagnosis of non-small cell lung cancer (e.g., Epidermal Growth Factor Receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) with SCLC transformation). Mixed histology (aka combined small cell) histology tumors are permitted if the majority component is small cell histology.
    • Chemotherapy must consist of a platinum agent (carboplatin or cisplatin) and etoposide.
    • Definitive radiation may include daily treatment ≥ 60 gray (Gy) or twice-daily treatments 45 Gy or other biologically equivalent regimens given concurrently with chemotherapy.
    • For early LS-SCLC (e.g., T1-2, N0, M0) without lymph node involvement, treatment with stereotactic ablative radiotherapy (SABR/SBRT) and chemotherapy is allowed.
    • Prophylactic cranial radiation (PCI) is permitted but not required. If PCI is administered, 7 day is required before start of study treatment.

      • PCI consists of whole brain radiation therapy delivered in the absence of . Hippocampal-sparing whole brain plans are considered PCI.
    • Patient must be able to be randomized and have planned cycle 1 day 1 treatment within 42 days of the last dose of thoracic radiation therapy or end of last cycle of chemotherapy, whichever was given most recently.
  • Completed chemotherapy and radiation with no evidence of progression of disease per Response Evaluation Criteria for Solid Tumors () v1.1 (i.e., achieved complete response, partial response, or stable disease), including no evidence of disease on brain MRI, after treatment but prior to randomization.
  • Patient must be ≥ 18 years of age.
  • Patient must have an (ECOG) performance status of 0-1.
  • Patient must have the ability to understand and willingness to sign a written document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  • Patient must be willing to provide archived tumor tissue (if available) for research.
  • Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to randomization (Echocardiogram (ECHO)/Multi-Gated Acquisition () ≤ 28 days).

    • (ANC) ≥ 1500/microliter (mcL)
    • ≥ 8.0 g/dL
    • ˃100,000/mcL
    • (PT)/international normalized ratio (INR) ≤ 1.5x upper limit normal () except for patients on stable dose anticoagulation for 6 weeks prior to randomization.
    • Activated partial thromboplastin Time (aPTT) ≤ 1.5x ULN except for patients on stable dose anticoagulation for 6 weeks prior to randomization.
    • Serum Creatinine ≤ 2x ULN
    • (CrCl) ≥ 30 mL/min
    • (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) ≤ 2.5x ULN
    • Total ≤ 1.5x ULN or ≤ 2x ULN for patients with documented Gilbert's disease
    • No evidence of (HIV) within 6 months of randomization.
    • virus (HBV) and virus (HCV) negative within 6 months of randomization.
    • Pulmonary Function: No oxygen supplementation
    • (ECG) with no findings of acute/subacute ischemia and/or arrythmia
    • Cardiac Function: Cardiac ejection fraction ≥ 50% and no large or symptomatic pericardial effusion requiring intervention
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
  • Patient must not expect to conceive, or father children by using an accepted and highly effective method(s) of or by abstaining from sexual intercourse for the duration of their participation in the study, and for 90 days after the last dose of study drug(s). Also, patient must not expect to breastfeed, donate eggs, or donate sperm during study or for 90 days after the last dose of study drug(s).
  • Patient with a prior or concurrent whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial.
  • Patient must not have had major surgery within 28 days, or minor surgery within 10 days, before randomization.
  • Patient must not have a history of clinically significant interstitial lung disease or active pneumonitis requiring treatment. Patients with grade 1 radiation pneumonitis or fibrosis are permitted to enroll.
  • Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the (NYHA) Functional Classification (NYHA Classification). To be eligible for this trial, patient must be class IIB or better.
  • Patients with history of disorders are eligible to enroll only if no disease flares and not requiring any systemic agents in the past 5 years. Topical or inhaled steroids are permitted. The following are not exclusionary: vitiligo, asthma, endocrine disorders that required only hormone replacement, psoriasis or other skin disorders that do not require systemic treatment, celiac disease controlled by diet alone.
  • Patients with active primary immunodeficiency are not permitted to enroll.
  • Prior history of severe or life-threatening events ( (CTCAE) V6.0 grade ≥ 3) from any immune-related therapy.
  • Patients with any condition requiring chronic oral corticosteroids is eligible if steroid dose is ≤ 10 mg/day prednisone equivalent. Physiologic replacement doses for adrenal insufficiency are permitted even if dose exceeds 10 mg/day. Inhaled corticosteroids and local steroid injections are permitted. All other uses of steroids must be tapered to ≤ 10 mg/day before randomization.
  • Patients must not have a history of allogeneic solid organ, allogeneic bone marrow or stem cell transplantation.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within for 6 months of before randomization are eligible for this trial.
  • Patient must not have received any within 28 days prior to randomization.
  • Patients with a known allergy to any of the study medications, their analogues, or in the various formulations of any agent are not eligible.
  • Any prior therapy with a selective inhibitor of the DLL3 pathway is not permitted.
  • Any prior therapy with immune-mediated therapy including , anti-PD-1, or anti PD-L1 is not permitted.
  • Receiving another anti-cancer therapy is not permitted except for hormonal therapy for breast or prostate cancer, topical therapies for cutaneous malignancies, or superficial treatments for non-muscle invasive bladder cancers.
  • Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.
  • Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.
Terms in these criteria, in plain language(32)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
430 participants (estimated)

Study arms

  • Experimental
    Arm A: Tarlatamab in Combination with Durvalumab

    Tarlatamab in combination with durvalumab. 1 cycle = 28 days.

    Drug: Tarlatamab · Drug: Durvalumab

  • Active comparator
    Arm B: Durvalumab

    Durvalumab only. 1 cycle = 28 days.

    Drug: Durvalumab

Interventions

  • Tarlatamab Intravenous (IV): Cycle 1 Step Dose: Day 1- 1 mg; Day 8- 10 mg; Day 15- 10 mg of a 28-day cycle, then Cycle 2 and Subsequent Cycles: Day 1- 10 mg and Day 15- 10 mg every 28-day cycle up to 12 months from cycle 1 day 1 unless other treatment discontinuation or rechallenge criteria are met.

    Also known as: AMG 757, IMDELLTRA

  • Durvalumab 1500 mg IV: Every 4 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months from cycle 1 day 1, unless other treatment discontinuation criteria are met.

    Also known as: MEDI4736, IMFINZI®

06

What researchers measure

Primary outcomes

  1. This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).

    The dual primary endpoints are PFS by Blinded Independent Central Review (BICR) and OS. OS is defined as time from randomization until death due to any cause.

    Time frame: From randomization until death due to any cause, assessed up to 131 months.

  2. This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).

    The dual primary endpoints are PFS by Blinded Independent Central Review (BICR) and OS. PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first, in the absence of subsequent anticancer therapy. For participants with post-baseline imaging assessments, PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy or the earlier of the following, where applicable: (a) the last evaluable post-baseline tumor assessment prior to or on subsequent anticancer therapy, or (b) the last post-baseline assessment that precedes two or more consecutive missing/not evaluable assessments followed by disease progression or death. For participants with no post-baseline imaging assessments, PFS will be censored at the date of randomization.

    Time frame: From randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first, assessed up to 131 months.

Secondary outcomes

  1. Secondary endpoints include safety/tolerability.

    Toxicity will be determined using the CTCAE V6.0. Toxicity will be assessed by summaries by CTCAE grade. Participants will be followed for adverse events for 90 (+5) days after their last dose of study medication. However, if a participant experiences an adverse event \>90 (+5) days after their last dose of study medication that is felt to be, in the opinion of the investigator, possibly, probably or definitely related to study therapy, the adverse event should be reported.

    Time frame: From treatment start to 90 (+5) days after their last dose of study medication.

  2. Secondary endpoints include investigator-assessed PFS.

    Secondary objectives include to evaluate the difference in investigator-assessed PFS per RECIST 1.1 with tarlatamab + durvalumab as compared to durvalumab alone.

    Time frame: From randomization until the first documentation of investigator-assessed radiologic disease progression or death due to any cause, whichever occurs first, assessed up to 131 months.

  3. Secondary endpoints 3 and 5-year PFS rate

    3 and 5-year PFS is defined as the Kaplan-Meier-estimated probabilities of being alive and progression-free at 3 years and 5 years.

    Time frame: From randomization to 3 and 5 years after randomization.

  4. Secondary endpoints include 3 and 5-year OS rate.

    3 and 5-year OS is defined as the Kaplan-Meier-estimated probabilities of being alive at 3 years and 5 years.

    Time frame: From randomization to 3 and 5 years after randomization.

  5. Secondary endpoints include cumulative incidence Central Nervous System (CNS) metastases.

    The BICR will conduct 2 assessments of tumor response using RECIST 1.1: one for the overall systemic disease (based on non-target and new lesions) and one solely for the evaluation of CNS endpoints (based on brain metastases only).

    Time frame: From randomization until last follow-up, assessed up to 131 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Data is proprietary

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Nov 2037, 130 months later.

Of 69 phase 3 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 48. This study's planned 130 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2026
First posted
Jun 9, 2026
StartEst.
Jan 2027
Primary completionEst.
Nov 2037
CompletionEst.
Jun 2038
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07637513
Lead sponsor
PrECOG, LLC.
Collaborators
Amgen
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Jan 2027 (estimated)
Primary completion
Nov 2037 (estimated)
Completion
Jun 2038 (estimated)
Last update
Jun 9, 2026

Study contacts

Irini Jorgji, PSM
Contact
PrE0512@precogllc.org
215-789-3646 ext. 3646
Ryan Gentzler, MD, MS
study chair · University of Virginia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: AMG 757

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