ClinicalTrials.gg
RecruitingNCT07809256LPR-2Updated Sep 9, 2026

A Prospective, Single-center, Non-randomized, Interventional Study on the Effectiveness and Safety of Combined Immunotargeted Therapy in Patients With Metastatic Non-small Cell Cancer With a RET Gene Translocation

A Phase 3 interventional study of lenvatinib pembrolizumab in NSCLC (Non-small Cell Lung Cancer)R, sponsored by EuroCityClinic LLC. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by EuroCityClinic LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 84 studies in Carcinoma, Non-Small-Cell Lung with a site in Russia — 4 open to participants now, 45 under way, 31 of them phase 3. Carcinoma, Non-Small-Cell Lung · Russia.

Planned enrollment
80th of 80
15 · median 443
Started
2026
the only one that year
Phase 3
58 of 84
1 open now
Primary completion
2028-08
later than 42 of 44 live
Registered
84th of 84
by date
Lead sponsor
2 of 84
EuroCityClinic LLC

Among the 84 studies in Carcinoma, Non-Small-Cell Lung with a site in Russia, this one is the 80th largest by planned enrollment of the 80 interventional ones that give a count, is the only one that started in 2026, is one of 58 in phase 3, reaches primary completion later than 42 of the 44 other live ones, and was the 84th registered.

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

4 of the 84 studies in Carcinoma, Non-Small-Cell Lung with a site in Russia are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Russia have not opened yet or have stopped. Only those recruiting at a site in Russia →

Who these studies take

Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This interventional study will evaluate the effectiveness, safety, and tolerability of pembrolizumab in combination with lenvatinib in adults with metastatic non-small cell lung cancer (NSCLC) who have a confirmed RET gene rearrangement and whose disease has progressed after one or more previous systemic treatments.

Participants will receive pembrolizumab intravenously once every 3 weeks in combination with lenvatinib taken by mouth daily until disease progression, unacceptable side effects, or treatment discontinuation. Tumor response will be assessed using imaging studies according to RECIST 1.1, and participants will be monitored for treatment-related side effects, progression-free survival, and overall survival. The study will also evaluate clinical and tumor characteristics, RET rearrangement variants, and the diagnostic methods used to confirm RET-positive status.

03

Conditions studied

  • NSCLC (Non-small Cell Lung Cancer)R

Keywords

  • RET fusion
  • NSCLC
  • Pembrolizumab
  • Lenvatinib
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Be able and willing to sign a written form before taking part in the study.
  2. Be 18 years of age or older.
  3. Have a confirmed diagnosis of non-small cell lung cancer (NSCLC), established by examination of a tumor tissue sample, with cancer that has spread to distant parts of the body.
  4. Have a confirmed RET gene rearrangement, identified using a validated molecular test, such as next-generation sequencing (NGS), polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another validated method.
  5. Have previously received treatment for metastatic NSCLC and have experienced disease progression during or after at least one previous line of standard systemic chemotherapy or targeted therapy.
  6. Have previously received platinum-containing chemotherapy for metastatic NSCLC and have experienced disease progression during or after this treatment.
  7. Have an (ECOG) performance status of 0 or 1, meaning that the participant is fully active or able to perform light daily activities.
  8. Have at least one tumor lesion that can be measured on imaging according to the version 1.1 (RECIST 1.1).
  9. Have an expected of at least 3 months.
  10. Have adequate blood cell counts at screening, defined as:

    • of at least \(1.5 \times 10\^9/L\);
    • count of at least \(100 \times 10\^9/L\);
    • level of at least 90 g/L.

    The participant must not have received a blood transfusion or transfusion of blood components within 14 days before starting study treatment.

  11. Have adequate liver function at screening, defined as:

    • total no higher than 1.5 times the (ULN); participants with Gilbert syndrome may have a total bilirubin level up to 3 times the ULN;
    • (AST) and alanine aminotransferase (ALT) levels below 3 times the ULN; for participants with liver metastases, levels below 5 times the ULN are allowed;
    • alkaline phosphatase (ALP) level below 3 times the ULN; for participants with liver and/or bone metastases, a level below 5 times the ULN is allowed.
  12. Have adequate kidney function at screening, defined as:

    • serum creatinine no higher than 1.5 times the ULN; or
    • of at least 50 mL/min if the serum creatinine level is higher than 1.5 times the ULN.

    Creatinine clearance will be calculated according to local medical standards. If no local standard is available, it may be calculated using the Cockcroft-Gault formula. Estimated (eGFR) may also be used instead of serum creatinine or creatinine clearance, according to the study protocol.

  13. Have a thyroid-stimulating hormone (TSH) level within the normal range at screening. At the investigator's discretion, a participant with a TSH level outside the normal range may still be eligible if the triiodothyronine (T3) and free thyroxine (free T4) levels are within the normal range.

Exclusion criteria

Exclusion Criteria:

  1. They have previously received treatment with lenvatinib.
  2. They have had a severe allergic or reaction to pembrolizumab, lenvatinib, any component of the study medicines, or similar medicines, including human, humanized, or mouse monoclonal antibodies or immunoglobulin medicines.
  3. They have an active disease.
  4. They have cancer that has spread to the central nervous system or has caused carcinomatous meningitis. Participants with may be eligible if the brain metastases were adequately treated with radiation therapy and/or surgery and have remained stable on imaging studies.
  5. They have a heart condition, including uncontrolled high blood pressure, coronary artery disease or any type of angina, a previous heart attack or post-heart-attack heart damage, or heart failure classified as (NYHA) class II or higher.
  6. Imaging or clinical examination shows that the tumor has invaded blood vessels or is located close to major blood vessels, and the investigator believes that this could increase the risk of bleeding.
  7. They have severe kidney or liver failure.
  8. They have any known allergy to an ingredient in the study medicines.
  9. They are pregnant or breastfeeding.
  10. They have uncontrolled high blood pressure despite treatment, defined as systolic blood pressure above 150 mmHg and/or diastolic blood pressure above 100 mmHg. Participants with a hypertensive crisis or hypertensive encephalopathy are also excluded.
  11. They have another serious medical condition that, in the investigator's opinion, could affect participation in the study or the safety of the participant.
  12. They have ongoing side effects from previous treatment that are more severe than Grade 1.
  13. Women who could become pregnant are not willing to use an effective method of during the study and for at least 30 days after the last dose of the study medicines.
  14. Men with partners who could become pregnant are not willing to use an effective method of contraception during the study and for at least 30 days after the last dose of the study medicines.
Terms in these criteria, in plain language(19)

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.

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.

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

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.

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).

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.

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.

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.

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.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Lenvatinib, Pembrolizumab

    Combination Product: lenvatinib pembrolizumab

Interventions

  • Combination productlenvatinib pembrolizumab

    Participants will receive pembrolizumab intravenously every 3 weeks in combination with lenvatinib, which is taken orally every day until disease progression, unacceptable side effects, or treatment is stopped.

This study also gives Pembrolizumab, Lenvatinib. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented disease progression (PD) according to the investigator's assessment using RECIST v1.1 criteria, or to death from any cause-whichever happens first. Disease progression (PD) is recorded when the sum of diameters (SOD) of target lesions increases by at least 20% from the smallest SOD previously recorded, including the baseline. In addition to the 20% relative increase, there must also be an absolute increase in SOD of at least 5 mm.

    Time frame: Up to 48 months.

  2. Objective Response Rate (ORR)

    The objective response rate (ORR) is calculated as the proportion of participants whose best overall response (BOR) reaches either a complete (CR) or partial (PR) response for both target and non-target lesions. A complete response (CR) is defined as the disappearance of all target and non-target lesions, with any pathological lymph nodes (whether target or non-target) shrinking to less than 10 mm in short-axis diameter. A partial response (PR) is recorded when the sum of diameters of target lesions decreases by at least 30% from baseline. Tumor burden is assessed according to modified RECIST 1.1 criteria: up to five target lesions in total are considered, with no more than two lesions per organ.

    Time frame: Up to 48 months.

  3. Disease Control Rate (DCR)

    The disease control rate (DCR) is calculated as the proportion of participants who, according to the investigator's assessment based on RECIST v1.1 criteria, achieve the best overall response of complete response (CR), partial response (PR), or stable disease (SD). Stable disease (SD) is defined as not enough reduction in tumor burden to qualify as CR or PR, and at the same time not enough increase to qualify as disease progression (PD). A complete response (CR) is recorded when all target lesions disappear; any pathological lymph nodes must shrink to less than 10 mm in the short axis. A partial response (PR) is noted when the sum of diameters (SOD) of all target lesions decreases by at least 30% compared to the baseline SOD, without signs of a CR. Disease progression (PD) is defined as an increase in the SOD of target lesions by at least 20% compared to the smallest recorded SOD at previous time points (including baseline); in addition to the 20% relative increase, there also needs t

    Time frame: Up to 48 months.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data will not be routinely shared with other researchers. Study results will be reported in aggregate form in scientific publications and presentations. De-identified individual participant data may be considered for sharing only when required by applicable laws, regulations, institutional policies, or ethics committee requirements, and subject to protection of participant privacy and confidentiality.

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 Sep 2026; primary completion for Aug 2028, 23 months later.

Of 109 non-industry phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 129. This study's planned 23 months is below that.

Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.

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

Registered
Aug 26, 2026
First posted
Sep 9, 2026
StartEst.
Sep 2026
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2030
Last update
Sep 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 Sep 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
NCT07809256
Lead sponsor
EuroCityClinic LLC
Responsible party
Sergey Orlov (Doctor of Medical Sciences, Professor, EuroCityClinic LLC) — Principal investigator
First posted
Sep 9, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2030 (estimated)
Last update
Sep 9, 2026

Study contacts

Sergey Orlov, Doctor of Medical Sciences, Pr
Contact
orloff-sv@mail.ru
+7 918 603 48 38
Maria Sviridenko, MD
Contact
sviridenko944@gmail.com
+79215990021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Pembrolizumab · Lenvatinib

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