NSCLC (Non-small Cell Lung Cancer)RPhase 3LPR-2NCT07809256
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 study testing lenvatinib pembrolizumab in people with NSCLC (Non-small Cell Lung Cancer)R, run by EuroCityClinic LLC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)R
- What is being tested?
- lenvatinib pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2026to Aug 2030
- Phase
- Phase 3
- 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
- Be able and willing to sign a written informed consent form before taking part in the study.
- Be 18 years of age or older.
- Have a confirmed diagnosis of metastatic 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.
- 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.
- 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.
- Have previously received platinum-containing chemotherapy for metastatic NSCLC and have experienced disease progression during or after this treatment.
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- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, meaning that the participant is fully active or able to perform light daily activities.
- Have at least one tumor lesion that can be measured on imaging according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- Have an expected life expectancy of at least 3 months.
- Have adequate blood cell counts at screening, defined as:
- absolute neutrophil count of at least \(1.5 \times 10^9/L\);
- platelet count of at least \(100 \times 10^9/L\);
- hemoglobin 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.
- Have adequate liver function at screening, defined as:
- total bilirubin no higher than 1.5 times the upper limit of normal (ULN); participants with Gilbert syndrome may have a total bilirubin level up to 3 times the ULN;
- aspartate aminotransferase (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.
- Have adequate kidney function at screening, defined as:
- serum creatinine no higher than 1.5 times the ULN; or
- creatinine clearance 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 glomerular filtration rate (eGFR) may also be used instead of serum creatinine or creatinine clearance, according to the study protocol.
- 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.
Who cannot join
- They have previously received treatment with lenvatinib.
- They have had a severe allergic or hypersensitivity reaction to pembrolizumab, lenvatinib, any component of the study medicines, or similar medicines, including human, humanized, or mouse monoclonal antibodies or immunoglobulin medicines.
- They have an active autoimmune disease.
- They have cancer that has spread to the central nervous system or has caused carcinomatous meningitis. Participants with brain metastases may be eligible if the brain metastases were adequately treated with radiation therapy and/or surgery and have remained stable on imaging studies.
- They have a clinically significant 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 New York Heart Association (NYHA) class II or higher.
- 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.
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- They have severe kidney or liver failure.
- They have any known allergy to an ingredient in the study medicines.
- They are pregnant or breastfeeding.
- 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.
- They have another serious medical condition that, in the investigator's opinion, could affect participation in the study or the safety of the participant.
- They have ongoing side effects from previous treatment that are more severe than Grade 1.
- Women 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
EuroCityClinic LLC
Saint Petersburg, 197022
Maria Sviridenko, MD, +7 921 599 00 21, sviridenko944@gmail.com
About this study
Official title: LPR-2: 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
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.
- Conditions
- NSCLC (Non-small Cell Lung Cancer)R
- Being tested
- lenvatinib pembrolizumab
- Keywords
- RET fusion, NSCLC, Pembrolizumab, Lenvatinib
- 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.
lenvatinib pembrolizumabCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib, Pembrolizumab | Experimental | Not described Receives: Combination Product: lenvatinib pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 months.
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.
Measured: Up to 48 months.
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
Measured: Up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)RStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EuroCityClinic LLC
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Sergey Orlov, EuroCityClinic LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809256
- Sponsor's protocol ID
- 08Вн/26
- Acronym
- LPR-2
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LPR-2: 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
- ClinicalTrials.gov ID
- NCT07809256
- Acronym / sponsor ID
- LPR-2 / 08Вн/26
- Conditions
- NSCLC (Non-small Cell Lung Cancer)R
- Keywords
- RET fusion, NSCLC, Pembrolizumab, Lenvatinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- EuroCityClinic LLCResearch network
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 9 Sep 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib, Pembrolizumab | Experimental | Combination Product: lenvatinib pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Be able and willing to sign a written informed consent form before taking part in the study.
- Be 18 years of age or older.
- Have a confirmed diagnosis of metastatic 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.
- 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.
- 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.
Key exclusion criteria (14 listed)
- They have previously received treatment with lenvatinib.
- They have had a severe allergic or hypersensitivity reaction to pembrolizumab, lenvatinib, any component of the study medicines, or similar medicines, including human, humanized, or mouse monoclonal antibodies or immunoglobulin medicines.
- They have an active autoimmune disease.
- They have cancer that has spread to the central nervous system or has caused carcinomatous meningitis. Participants with brain metastases may be eligible if the brain metastases were adequately treated with radiation therapy and/or surgery and have remained stable on imaging studies.
- They have a clinically significant 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 New York Heart Association (NYHA) class II or higher.
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 |
|---|---|---|
| lenvatinib pembrolizumabParticipants 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. | Combination product | Lenvatinib, Pembrolizumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 48 months.
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.
Objective Response Rate (ORR)
Time frame: Up to 48 months.
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.
Disease Control Rate (DCR)
Time frame: Up to 48 months.
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
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 9 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lenvatinib pembrolizumab in people with NSCLC (Non-small Cell Lung Cancer)R, run by EuroCityClinic LLC at 1 site in Russia.
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 23 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 9 Sep 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 Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Sergey Orlov, Doctor of Medical Sciences, Pr (+7 918 603 48 38, orloff-sv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 48 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.