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Tests treatment safety and results for Metastatic Non-small Cell Lung Cancer (NSCLC)
Official title 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
What this study is testing
What is reICB regimen (NSCLC)?
reICB regimen (NSCLC) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic non-small cell lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York...
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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
- 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...
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Sankt-Peterburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Sankt-Peterburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.