Metastatic Non-small Cell Lung Cancer (NSCLC)Phase 2reICBNCT07130032
Efficacy And Safety Of Anti-PD-1/PD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade
A Phase 2 study testing reICB regimen (NSCLC) and reICB regimen (melanoma) in people with Metastatic Non-small Cell Lung Cancer (NSCLC) and Metastatic Cutaneous Melanoma, run by EuroCityClinic LLC at 1 site in Russia.
Trial summary
This study will evaluate efficacy and safety of anti-PD-1/PD-L1 antibodies combined with bevacizumab and metronomic cyclophosphamide in patients with metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma previously treated with immune checkpoint blockade (ICB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer (NSCLC), Metastatic Cutaneous Melanoma
- What is being tested?
- reICB regimen (NSCLC) and reICB regimen (melanoma)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteRussia
- Study dates
- 14 Aug 2025to Dec 2027
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Provide written informed consent
- Age ≥ 18 years
- Histologically confirmed diagnosis of NSCLC and cutaneous melanoma with distant metastases.
- No mutations in the EGFR gene, ALK, ROS1, RET gene translocations (in case of NSCLC).
- For NSCLC: the individuals had previously received anti-PD-(L)1 antibodies in combination with platinum-containing chemotherapy either in the first line or sequentially in the first and second lines for the treatment of metastatic disease.
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- For NSCLC: the individuals had previously received anti-PD-(L)1 antibodies for >6 months and experienced disease progression.
- For cutaneous melanoma: the individuals had previously received anti-PD-1 antibodies either in combination with or without anti-CTLA4 therapy for metastatic disease. If the patient had the BRAF V600 mutation, they were also treated with BRAF and MEK inhibitors.
- For cutaneous melanoma: the patient has previously received anti-PD-1 antibodies with or without anti-CTLA4 therapy for metastatic disease for >6 months and experienced disease progression
Who cannot join
- Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias.
- Stroke and/or transient ischemic attack within 6 months prior to screening;
- Uncontrolled hypertension
- History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at least 2 years prior to randomization AND no additional therapy is required during the study period. Patients having hepatic involvement of cancer should be excluded as per investigator assessment.
- Patients with CNS metastases are eligible only if the metastases are adequately treated.
- Absolute neutrophil count (ANC) <1.5×109/L, platelet count <100×109/L, or hemoglobin <9.0 g/dL.
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- Serum total bilirubin >1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin <2 X ULN, and normal AST/ALT are eligible;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × ULN;
- Serum creatinine >1.5 × ULN.
- History of a thromboembolic event
- Presence of any allergic reactions to components of the study drugs
- Concomitant medications with a known risk of causing QT prolongation and/or Torsades de Pointes.
- Any parallel anti-cancer systemic therapy, radiation therapy
- Women who are pregnant or lactating;
- Presence of unresolved adverse events of grade 2 or higher toxicity, according to CTCAE v5.0 criteria, from prior therapy (except for alopecia or neurotoxicity grade≤2).
- Any other serious or uncontrolled medical disorder, active infection, physical examination finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a patient's ability to comply with the study requirements, substantially increase risk to the patient, or impact the interpretability of study results.
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, Sankt-Peterburg, 197022
Aram A. Musaelyan, PhD, +79990263455, a.musaelyan8@gmail.com
About this study
Official title: A Trial To Compare Efficacy And Safety Of Anti-PD-1/PD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade
This study will evaluate efficacy and safety of anti-PD-1/PD-L1 antibodies combined with bevacizumab and metronomic cyclophosphamide in patients with metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma previously treated with immune checkpoint blockade (ICB). The hypotheses of this study are that a combination of ICB, cyclophosphamide, and bevacizumab prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.
Read the detailed description
The main challenge in treating metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma is acquired resistance to PD-1/PD-L1 blockade. Mechanisms of resistance include loss of antigen expression, defects in the IFN-γ signaling pathway, decreased PD-L1 expression, and upregulation of alternative immune checkpoints. Additionally, changes in the tumor microenvironment, such as an increase in regulatory T cells (Tregs), myeloid-derived suppressor cells, and angiogenesis, create an immunosuppressive environment that reduces T-cell activity.
Bevacizumab, a monoclonal antibody against VEGF-A, has demonstrated the ability to "normalize" tumor vasculature, thereby improving perfusion, reducing hypoxia, and facilitating immune cell infiltration into tumors. Results from several phase III trials in renal cell carcinoma, NSCLC, and hepatocellular carcinoma have shown that combining PD-1/PD-L1 antibodies with anti-VEGF therapy significantly improves ORR and progression-free survival (PFS) compared to using either immunotherapy alone or standard chemotherapy.
Metronomic chemotherapy involves administering low doses of cytotoxic agents continuously. This therapy targets tumor endothelial cells and modulates the immune milieu rather than direct cytotoxic elimination of malignant cells. Metronomic cyclophosphamide specifically depletes cells and activates effector cells. Additionally, metronomic cyclophosphamide can boost antigen presentation by activating dendritic cells, enhancing anti-tumor T-cell responses. In preclinical NSCLC models, combining metronomic cyclophosphamide with PD-1 blockade led to lasting tumor regression. This was due to the antiangiogenic and immunomodulatory properties of metronomic cyclophosphamide, resulting in reduced microvessel density and increased CD8⁺ T-cell infiltration.
Targeting multiple pathways of acquired resistance simultaneously with three agents can result in synergistic effects. This approach can convert immunologically "cold" tumors into "hot" ones. In preclinical studies, combining PD-L1 blockade with VEGF blockade increased T-cell infiltration and remodeled the vasculature, while combining PD-L1 blockade with metronomic chemotherapy improved antigen presentation and increased the ratio of effector-to-regulatory T-cells. In our recent retrospective study of 43 patients with metastatic NSCLC previously treated with ICIs, the safety and efficacy of rechallenging with ICIs and metronomic cyclophosphamide with or without bevacizumab were evaluated. The combination of ICIs with cyclophosphamide produced an ORR of 16.7%, a DCR of 75.0%, a median PFS of 5.8 months, and an OS of 15.4 months. In the cohort receiving oral cyclophosphamide plus bevacizumab, the ORR was 26.3%, DCR 78.9%, PFS 6.8 months, and OS 17.6 months. Adverse events related to treatment did not lead to discontinuation of the investigational therapy in either group.
- Being tested
- reICB regimen (NSCLC), reICB regimen (melanoma)
- Keywords
- Metastatic non-small cell lung cancer, Metastatic cutaneous melanoma, Immune checkpoint inhibitor, Bevacizumab, Metronomic cyclophosphamide
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reICB regimen (NSCLC)Combination product
- ICI (one of the following): Atezolizumab 1200 mg every 3 weeks/Nivolumab 240 mg every 2 weeks/Pembrolizumab 200 mg every 3 weeks
- Cyclophosphamide 50 mg PO daily
- Bevacizumab 7.5 mg/kg every 3 weeks
reICB regimen (melanoma)Combination product
- ICI (one of the following): Nivolumab 240 mg every 2 weeks/Pembrolizumab 200 mg every 3 weeks
- Cyclophosphamide 50 mg PO daily
- Bevacizumab 7.5 mg/kg every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| NSCLC (n=60) | Experimental | The cohort of individuals with metastatic NSCLC will be treated with the reICB regimen (anti-PD(L)-1 antibodies+ cyclophosphamide+ bevacizumab) until disease progression or unacceptable toxicity. Receives: Combination Product: reICB regimen (NSCLC) |
| melanoma (n=30) | Experimental | The cohort of individuals with metastatic cutaneous melanoma will be treated with the reICB regimen (anti-PD(L)-1 antibodies+ cyclophosphamide+ bevacizumab) until disease progression or unacceptable toxicity. Receives: Combination Product: reICB regimen (melanoma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
objective response rate (ORR) was defined as the proportion of participants whose best overall outcome included a confirmed complete response (CR) or partial response (PR). PR corresponds to a minimum 30% reduction in the total diameter of target lesions compared to the baseline measurements. CR indicates the total disappearance of all identified target lesions. Additionally, any pathological lymph nodes (classified as target or non-target) must shrink to a short axis measurement below 10 millimeters (mm).
Measured: From randomization until the first documentation of best overall response (up to 24 months)
Progression-free Survival (PFS) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
Progression-free survival (PFS) was defined as the time from randomization to the initial occurrence of documented disease progression (PD) or death from any cause, whichever occurs earlier. PD was characterized by at least a 20% enlargement in the total diameter of target lesions compared to the smallest sum recorded during the study, along with an absolute increase of 5 mm or more. The development of any new lesions was also classified as PD.
Measured: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Overall Survival (OS)
Overall survival (OS) was measured as the duration (in months) from date of randomization to death resulting from any cause. Participants who had not experienced death by the time of data analysis were censored at their most recent confirmed date of survival.
Measured: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Secondary outcomes (3)
Disease Control Rate (DCR) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
DCR defined as the proportion of participants with confirmed complete response (CR), partial response (PR), or stable disease (SD) as their best overall response. PR: A reduction of at least 30% in the total diameter of target lesions relative to the initial baseline measurements. CR: The complete resolution of all identified target lesions. Pathological lymph nodes (target or non-target) must also exhibit a short axis reduction to under 10 mm. SD: Lesions showing neither sufficient shrinkage to meet PR criteria nor sufficient growth to qualify as progressive disease (PD), using the smallest total lesion size recorded during the study as the reference point. PD: Defined as a minimum 20% increase in the total diameter of target lesions compared to the lowest recorded measurement (nadir), which must also include an absolute increase of ≥5 mm. The emergence of new lesions also constitutes PD.
Measured: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Duration of Response (DOR) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
DOR was measured as the time (in months) from the initial documentation of a partial response (PR) or complete response (CR) until the first confirmed instance of disease progression (PD) or death from any cause, whichever occurred earlier.
Measured: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) refers to any unfavorable or unintended medical event experienced by a participant in a clinical trial involving a medicinal product, regardless of whether it is causally linked to the treatment. A treatment-emergent adverse event (TEAE) was defined as an AE that: began on or after the start of treatment, had an unspecified onset date, existed prior to treatment but worsened in severity after treatment initiation, continuing until 30 days after the final dose of the study drug or the start of subsequent anti-tumor therapy (whichever occurred first). Additionally, serious adverse events (SAEs) deemed treatment-related were classified as TEAEs even if they occurred after this 30-day period. AEs with missing or unreported onset dates were also categorized as TEAEs. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From start of study drug administration up to approximately 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start14 Aug 2025
- Primary completion14 Aug 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung Cancer (NSCLC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EuroCityClinic LLC
- Sponsor type
- Research network
- Collaborators
- First Pavlov State Medical University in St. Petersburg, Russia
- Responsible party
- Principal investigator, Aram Musaelyan, EuroCityClinic LLC
- Investigators
- Sergey V. Orlov, Professor, Principal investigator, EuroCityClinic LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130032
- Sponsor's protocol ID
- 1.0
- Acronym
- reICB
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial To Compare Efficacy And Safety Of Anti-PD-1/PD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade
- ClinicalTrials.gov ID
- NCT07130032
- Acronym / sponsor ID
- reICB / 1.0
- Keywords
- Metastatic non-small cell lung cancer, Metastatic cutaneous melanoma, Immune checkpoint inhibitor, Bevacizumab, Metronomic cyclophosphamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- EuroCityClinic LLCResearch network
- Collaborators
- First Pavlov State Medical University in St. Petersburg, Russia
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 14 Aug 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Aug 2025 (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 study will evaluate efficacy and safety of anti-PD-1/PD-L1 antibodies combined with bevacizumab and metronomic cyclophosphamide in patients with metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma previously treated with immune checkpoint blockade (ICB). The hypotheses of this study are that a combination of ICB, cyclophosphamide, and bevacizumab prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.
Detailed description
The main challenge in treating metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma is acquired resistance to PD-1/PD-L1 blockade. Mechanisms of resistance include loss of antigen expression, defects in the IFN-γ signaling pathway, decreased PD-L1 expression, and upregulation of alternative immune checkpoints. Additionally, changes in the tumor microenvironment, such as an increase in regulatory T cells (Tregs), myeloid-derived suppressor cells, and angiogenesis, create an immunosuppressive environment that reduces T-cell activity.
Bevacizumab, a monoclonal antibody against VEGF-A, has demonstrated the ability to "normalize" tumor vasculature, thereby improving perfusion, reducing hypoxia, and facilitating immune cell infiltration into tumors. Results from several phase III trials in renal cell carcinoma, NSCLC, and hepatocellular carcinoma have shown that combining PD-1/PD-L1 antibodies with anti-VEGF therapy significantly improves ORR and progression-free survival (PFS) compared to using either immunotherapy alone or standard chemotherapy.
Metronomic chemotherapy involves administering low doses of cytotoxic agents continuously. This therapy targets tumor endothelial cells and modulates the immune milieu rather than direct cytotoxic elimination of malignant cells. Metronomic cyclophosphamide specifically depletes cells and activates effector cells. Additionally, metronomic cyclophosphamide can boost antigen presentation by activating dendritic cells, enhancing anti-tumor T-cell responses. In preclinical NSCLC models, combining metronomic cyclophosphamide with PD-1 blockade led to lasting tumor regression. This was due to the antiangiogenic and immunomodulatory properties of metronomic cyclophosphamide, resulting in reduced microvessel density and increased CD8⁺ T-cell infiltration.
Targeting multiple pathways of acquired resistance simultaneously with three agents can result in synergistic effects. This approach can convert immunologically "cold" tumors into "hot" ones. In preclinical studies, combining PD-L1 blockade with VEGF blockade increased T-cell infiltration and remodeled the vasculature, while combining PD-L1 blockade with metronomic chemotherapy improved antigen presentation and increased the ratio of effector-to-regulatory T-cells. In our recent retrospective study of 43 patients with metastatic NSCLC previously treated with ICIs, the safety and efficacy of rechallenging with ICIs and metronomic cyclophosphamide with or without bevacizumab were evaluated. The combination of ICIs with cyclophosphamide produced an ORR of 16.7%, a DCR of 75.0%, a median PFS of 5.8 months, and an OS of 15.4 months. In the cohort receiving oral cyclophosphamide plus bevacizumab, the ORR was 26.3%, DCR 78.9%, PFS 6.8 months, and OS 17.6 months. Adverse events related to treatment did not lead to discontinuation of the investigational therapy in either group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC (n=60) | Experimental | Combination Product: reICB regimen (NSCLC)The cohort of individuals with metastatic NSCLC will be treated with the reICB regimen (anti-PD(L)-1 antibodies+ cyclophosphamide+ bevacizumab) until disease progression or unacceptable toxicity. |
| melanoma (n=30) | Experimental | Combination Product: reICB regimen (melanoma)The cohort of individuals with metastatic cutaneous melanoma will be treated with the reICB regimen (anti-PD(L)-1 antibodies+ cyclophosphamide+ bevacizumab) until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Provide written informed consent
- Age ≥ 18 years
- Histologically confirmed diagnosis of NSCLC and cutaneous melanoma with distant metastases.
- No mutations in the EGFR gene, ALK, ROS1, RET gene translocations (in case of NSCLC).
Key exclusion criteria (16 listed)
- Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias.
- Stroke and/or transient ischemic attack within 6 months prior to screening;
- Uncontrolled hypertension
- History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at least 2 years prior to randomization AND no additional therapy is required during the study period. Patients having hepatic involvement of cancer should be excluded as per investigator assessment.
- Patients with CNS metastases are eligible only if the metastases are adequately treated.
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 |
|---|---|---|
| reICB regimen (NSCLC)* ICI (one of the following): Atezolizumab 1200 mg every 3 weeks/Nivolumab 240 mg every 2 weeks/Pembrolizumab 200 mg every 3 weeks * Cyclophosphamide 50 mg PO daily * Bevacizumab 7.5 mg/kg every 3 weeks | Combination product | NSCLC (n=60) |
| reICB regimen (melanoma)* ICI (one of the following): Nivolumab 240 mg every 2 weeks/Pembrolizumab 200 mg every 3 weeks * Cyclophosphamide 50 mg PO daily * Bevacizumab 7.5 mg/kg every 3 weeks | Combination product | melanoma (n=30) |
Primary outcome
Objective Response Rate (ORR) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: From randomization until the first documentation of best overall response (up to 24 months)
objective response rate (ORR) was defined as the proportion of participants whose best overall outcome included a confirmed complete response (CR) or partial response (PR). PR corresponds to a minimum 30% reduction in the total diameter of target lesions compared to the baseline measurements. CR indicates the total disappearance of all identified target lesions. Additionally, any pathological lymph nodes (classified as target or non-target) must shrink to a short axis measurement below 10 millimeters (mm).
Progression-free Survival (PFS) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Progression-free survival (PFS) was defined as the time from randomization to the initial occurrence of documented disease progression (PD) or death from any cause, whichever occurs earlier. PD was characterized by at least a 20% enlargement in the total diameter of target lesions compared to the smallest sum recorded during the study, along with an absolute increase of 5 mm or more. The development of any new lesions was also classified as PD.
Overall Survival (OS)
Time frame: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Overall survival (OS) was measured as the duration (in months) from date of randomization to death resulting from any cause. Participants who had not experienced death by the time of data analysis were censored at their most recent confirmed date of survival.
3 secondary outcomes
Disease Control Rate (DCR) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Duration of Response (DOR) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From start of study drug administration up to approximately 38 months
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 19 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Sergey V. Orlov, Professor principal investigator
EuroCityClinic LLC
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 reICB regimen (NSCLC) and reICB regimen (melanoma) in people with Metastatic Non-small Cell Lung Cancer (NSCLC) and Metastatic Cutaneous Melanoma, 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 9 inclusion and 16 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 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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?
Contact Sergey V. Orlov, Professor (+79811957915, orloff-sv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) (time frame: From randomization until the first documentation of best overall response (up to 24 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 19 Aug 2025.