Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Rilvegostomig Intravenous (IV) monotherapy

AZD2936

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.

This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-D (dose expansion).

The study includes 4 parts: Part A: Dose escalation; B \& C: Dose expansion non-randomized; D: Randomized RP2D \& alternative dose.

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

Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

Percentage of participants with AEs leading to discontinuation of rilvegostomig

Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1

Percentage of participants with a confirmed CR or PR according to RECIST v1.1

Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment

The time from first response according to RECIST v1.1 until progression or death in the absence of disease progression

The percentage of participants according to RECIST v1.1 with a confirmed CR or PR lasting 6 months or more

The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression

Evaluation of the target engagement of rilvegostomig in peripheral blood

Maximum observed plasma concentration of rilvegostomig

Area under the plasma concentration-time curve

A pharmacokinetic measurement of the volume of plasma from which the study intervention is completely removed per unit time.

Spots Global Cancer Trial Database for advanced, metastatic, solid tumor, solid tumour