Active — Not RecruitingPhase 1/2

A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

United States, Australia, Belgium212 participantsStarted 2021-09-14

Plain-language summary

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

Who can participate

Age range

18 Years – 130 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent * Aged 18 or above * Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation. * Documented PD-L1 expression by PD-L1 IHC per local report. * Part A and Part B: Confirmed progression during treatment with a CPI-including regimen. * Part C and Part D: No prior I/O treatment for metastatic NSCLC. * Part E: No prior treatment for metastatic NSCLC. * ECOG performance status of 0 or 1 at enrolment. * Life expectancy of ≥ 12 weeks at enrolment. * Have at least 1 measurable lesion per RECIST v1.1. * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion * Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation) * Previous treatment with an anti-TIGIT therapy * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. * Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI. * Part C and Part D: Any prior systemic treatment w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters

Timeframe: Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig

Rate of rilvegostomig discontinuation due to toxicity

Timeframe: Part A, B, C, D and E: From first dose to the last dose of rilvegostomig (an average of 6 months)

Objective Response Rate (ORR)

Timeframe: Part B, C, D and E: From first dose of rilvegostomig to progressive disease (PD) or death in the absence of disease progression (approximately 2 years)

Trial details

NCT IDNCT04995523

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-28

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