What is rilvegostomig studying for advanced or metastatic non-small cell lung cancer?

Rilvegostomig is being studied in combination with chemotherapy, with or without ramucirumab, to evaluate its safety and anti-tumor activity in people with advanced or metastatic NSCLC. This research aims to find effective new treatment combinations. AstraZeneca is leading this clinical trial to advance care options for this condition.

Who may be eligible for this advanced or metastatic NSCLC clinical trial?

Adults aged 18 years or older with confirmed stage IV NSCLC may be eligible. Participants must have measurable disease, acceptable tumor tissue samples, and adequate organ function. Those with certain genetic mutations or prior systemic therapy for advanced NSCLC are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced or metastatic NSCLC clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06996782

Study Evaluating New Drug Combinations Including Rilvegostomig with Chemotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer

Led by AstraZeneca · Updated on 2026-07-21

152

Participants Needed

103

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of new drug combinations, including rilvegostomig with standard platinum-based chemotherapy, with or without ramucirumab, for treating advanced or metastatic non-small cell lung cancer NSCLC. This study is open-label and multicenter, involving participants with confirmed stage IV NSCLC. It includes a sub-study with safety run-in and expansion parts to find the best dose and assess treatment activity. Participants receive treatments infused intravenously, including rilvegostomig, ramucirumab, and chemotherapy drugs like cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. Non-squamous NSCLC participants are randomly assigned to either rilvegostomig plus chemotherapy with ramucirumab or rilvegostomig plus chemotherapy alone, while squamous NSCLC participants receive rilvegostomig plus chemotherapy and ramucirumab. The study includes initial safety evaluation and dose expansion phases. During the study, participants undergo tumor tissue collection, disease measurements, and regular assessments of side effects, tumor response, and survival. Researchers monitor blood samples for drug levels and antibodies and track progression and overall survival over approximately 46 months. Safety, tolerability, and anti-tumor effects are closely followed throughout the treatment and observation periods.

CONDITIONS

Brief Title

A Platform Study in Non-Small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants with confirmed squamous or non-squamous NSCLC with current Stage IV metastatic NSCLC.
Provision of acceptable archival or fresh tumour tissue biopsy is required at screening.
Measurable disease with at least one lesion �3E= 10 mm.
Minimum life expectancy of 12 weeks as judged by the investigator.
Adequate organ and marrow function.
Use of contraception consistent with local regulations for participants in clinical studies.
Programmed death-ligand 1 (PD-L1) tumour proportion score (TPS) �3E= 1% for Sub Study 2.
Adequate coagulation and urinalysis for Sub Study 2.
Minimum body weight of 30 kg for Sub Study 2.

You will not qualify if you...

Participants with EGFR mutations, ALK fusions, or other genomic alterations with approved targeted first-line therapies.
Presence of small cell or neuroendocrine histology components.
Severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding, infections, interstitial lung disease, symptomatic venous thromboembolism, serious gastrointestinal conditions, active skin diseases, or substance abuse.
Prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
Active autoimmune disease requiring systemic treatment in the past 5 years.
History of significant arrhythmia, cardiomyopathy, or symptomatic congestive heart failure.
History of another primary malignancy treated with curative intent and no active disease for �3E= 2 years.
Persistent toxicities �3E= Grade 2 from previous anti-cancer therapy, excluding alopecia.
Spinal cord compression or symptomatic brain metastases.
Treatment with other anti-cancer agents or immunosuppressive medications.
Recent palliative radiotherapy within specified timeframes.
Known active hepatitis A, active or chronic hepatitis B or C infections.
Uncontrolled arterial hypertension �3E= 150/100 mm Hg.
Major blood vessel or airway invasion by cancer or intra-tumour cavitation.
Recent arterial thrombotic or severe bleeding events.
Significant bleeding disorders or relevant heart failure.
Bowel obstruction, inflammatory enteropathy, or extensive intestinal surgery.
Liver cirrhosis with complications.
Prior systemic therapy for advanced or metastatic NSCLC.
Prior exposure to anti-TIGIT, immune-oncology agents, or anti-VEGF therapies.
Contraindications to platinum doublet regimens or ramucirumab.
Known allergy or hypersensitivity to study drugs or excipients.

Research Team

AstraZeneca Clinical Study Information Center

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Study Evaluating New Drug Combinations Including Rilvegostomig with Chemotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria