Clinical trial for Advanced or Metastatic Non-small Cell Lung Cancer
Official title A Platform Study in Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT06996782
What this study is testing
What is Rilvegostomig?
This is an investigational medicine being studied as a potential treatment for advanced or metastatic non-small cell lung cancer.
Also referred to as AZD2936.
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 is testing whether new drug combinations work well. It also checks how safe they are.
- Who it's for
- You may be able to join if you have advanced non-small cell lung cancer.
- What's involved
- You would get a new drug mix or a new drug with standard care. You would have regular check-ups and tests.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- 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
- Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC.
- Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible)...
- Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter.
- Minimum life expectancy of 12 weeks in the opinion of the investigator.
- Adequate organ and marrow function.
You likely can't join if
- Participants with epidermal growth factor receptor mutations, anaplastic lymphoma receptor fusions or any other known genomic alteration for which...
- Presence of small cell and neuroendocrine histology components.
- Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection
- Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
- Has an active autoimmune disease that has required systemic treatment in the past 5 years.
- History of clinically significant arrhythmia, cardiomyopathy of any aetiology or symptomatic congestive heart failure.
See the full eligibility criteria
- Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC.
- Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible) is mandatory at screening.
- Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter.
- Minimum life expectancy of 12 weeks in the opinion of the investigator.
- Adequate organ and marrow function.
- Contraceptive use by male or female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Programmed death-ligand 1 (PD-L1) tumour proportion score (TPS) ≥ 1% (per local report).
- Adequate coagulation and urinalysis.
- Minimum body weight of 30 kg.
- Participants with epidermal growth factor receptor mutations, anaplastic lymphoma receptor fusions or any other known genomic alteration for which targeted therapy is approved in the first line per local standard of...
- Presence of small cell and neuroendocrine histology components.
- Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; interstitial lung disease/pneumonitis (of any grade)
- Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
- Has an active autoimmune disease that has required systemic treatment in the past 5 years.
- History of clinically significant arrhythmia, cardiomyopathy of any aetiology or symptomatic congestive heart failure.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention or presence of small cell and neuroendocrine...
- Persistent toxicities (common terminology criteria for adverse events [CTCAE] ≥ Grade 2) caused by previous anti-cancer therapy, excluding alopecia.
- Spinal cord compression or symptomatic brain metastases.
- Treatment with any other anti-cancer agents or immunosuppressive medication.
- Known active hepatitis A.
- Acute hepatitis B infection (anti-hepatitis B core antibody [HBc] immunoglobulin M [IgM] positive) or chronic hepatitis B infection with HBV DNA ≥ 2000 IU/mL.
- Active hepatitis C infection (anti-HCV positive with HCV RNA detectable) or anti- HCV positive with HCV RNA undetectable for less than 12 weeks following treatment for HCV.
- Known human immunodeficiency virus (HIV) infection that is not well controlled.
- Evidence of Grade ≥ 1 central nervous system (CNS) haemorrhage.
- Uncontrolled arterial hypertension ≥ 150 mm Hg (systolic) and/or ≥ 100 mm Hg (diastolic).
- Has radiologically documented evidence of major blood vessel invasion or encasement by cancer, or major airway invasion by cancer or intra-tumour cavitation.
- Has experienced any arterial thrombotic event, a Grade ≥ 3 bleeding event or has gross haemoptysis.
- Has significant bleeding disorders, serious or nonhealing wound, ulcer or clinically relevant congestive heart failure.
- Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
- Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
- Prior systemic therapy received for advanced or mNSCLC.
- Prior exposure to an anti-T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif domains (TIGIT) therapy or immune-oncology agent such as anti-programmed cell death protein 1 (PD-1)...
- Chronic therapy with antiplatelet agents.
- Prior exposure to anti-vascular endothelial growth factor (VEGF) therapy.
- Medical contraindication to protocol-specified platinum doublet regimens or ramucirumab.
- Known allergy or hypersensitivity to rilvegostomig or any of the excipients of rilvegostomig, cisplatin, carboplatin, paclitaxel or nab-paclitaxel or pemetrexed or ramucirumab.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Santa Rosa, California, United States
- Jacksonville, Florida, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Providence, Rhode Island, United States
- Tyler, Texas, United States
- Barretos, Brazil
- Fortaleza, Brazil
- Natal, Brazil
- Pelotas, Brazil
- Porto Alegre, Brazil
- São Paulo, Brazil
- Chongqing, China
- Deyang, China
- Guangzhou, China
- Jinan, China
- Shanghai, China
- Wuhan, China
+ 26 more site(s).
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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Santa Rosa, California, United States; Jacksonville, Florida, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Cleveland, Ohio, United States and 40 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.