A Platform Study in Non-Small Cell Lung Cancer (NSCLC)
A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe new treatments are and how well they work for non-small cell lung cancer that has spread to other parts of the body. It tests new treatments together or with standard treatment.
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have confirmed stage IV non-small cell lung cancer, either squamous or non-squamous type.
- Provide a stored tumor sample, or a new sample if none is stored and taking one is medically possible.
- Have at least one tumor spot that measures 10 mm or more.
- Be expected by the study doctor to live at least 12 weeks.
- Have organs and bone marrow that work well enough. Bone marrow makes blood cells.
- Follow local birth control rules for people in clinical studies.
- For Sub Study 2: Have the PD-L1 protein on at least 1% of tumor cells.
- For Sub Study 2: Weigh at least 30 kg (about 66 pounds) and have acceptable blood-clotting and urine tests.
Who can't join
- Have cancer gene changes with an approved targeted first treatment, or cancer that includes small cell or neuroendocrine cells.
- Have serious or uncontrolled illness, such as infection, lung inflammation, blood clots causing symptoms, bleeding, certain skin or bowel conditions, or substance abuse.
- Have had a transplant, certain serious heart problems, or an immune system disease needing whole-body treatment in the past 5 years.
- Have another cancer, unless treated to cure it with no known active disease for at least 2 years; ongoing moderate or worse side effects from cancer treatment, except hair loss; pressure on the spinal cord; or brain tumors causing symptoms.
- Receive other cancer drugs or medicines that weaken the immune system, or have had recent radiation for symptom relief within the study’s 2- or 4-week limits.
- For Sub Study 2: Have certain hepatitis infections, poorly controlled HIV, bleeding in the brain or spinal cord, blood pressure of 150/100 or higher that is not controlled, or certain serious bleeding or blood vessel problems.
- For Sub Study 2: Have certain cancer changes involving major blood vessels or airways, a cavity inside the tumor, serious wounds, heart failure, certain bowel problems, or severe liver scarring or its complications.
- For Sub Study 2: Have had drug treatment for advanced lung cancer, certain immune treatments, or treatments that block blood vessel growth; take long-term medicines that stop platelets from clotting; or cannot safely receive, or are allergic to, the listed study drugs.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. * Adequate organ and marrow function. Inclusion Criteria for Sub Study 2: * Programmed death-ligand 1 (PD-L1) tumour proportion score (TPS) ≥ 1% (per local report). * Adequate coagulation and urinalysis. * Minimum body weight of 30 kg. Exclusion Criteria: * 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 care. * 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); unstable and/or symptomatic venous thromboembolism, serious chronic gastrointestinal conditions associated with diarrhoea, active non-infectious skin disease or substance abuse. * 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 histology components. * 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. * Palliative radiotherapy with a limited field of radiation within 2 weeks or with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention. Exclusion Criteria for Sub Study 2: * 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), anti-PD-L1, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms. * 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.
Study sites (10)
AZ
- Research Site · Phoenix, AZ 85054More trials in Phoenix
CA
- Research Site · Santa Rosa, CA 95403More trials in Santa Rosa
FL
- Research Site · Jacksonville, FL 32224More trials in Jacksonville
MD
- Research Site · Baltimore, MD 21201More trials in Baltimore
MI
- Research Site · Detroit, MI 48202More trials in Detroit
MN
- Research Site · Rochester, MN 55905More trials in Rochester
OH
- Research Site · Cleveland, OH 44106More trials in Cleveland
RI
- Research Site · Providence, RI 02903More trials in Providence
- Research Site · Providence, RI 02906More trials in Providence
TX
- Research Site · Tyler, TX 75708More trials in Tyler