RECRUITING

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

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Conditions

Non-Small-Cell Lung CarcinomaTIGIT, Anti-TIGITPD-1, Anti-PD-1NSCLC, Non-small Cell Lung CancerAdvanced, Metastatic, Solid Tumor, Solid TumourStage 3 NSCLC, Stage III NSCLCStage 4 NSCLC, Stage IV NSCLCPD L1+ tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-14
Study Completion:2028-03-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04995523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent
  2. * Aged 18 or above
  3. * 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.
  4. * Documented PD-L1 expression by PD-L1 IHC per local report.
  5. * Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
  6. * Part C and Part D: No prior I/O treatment for metastatic NSCLC.
  7. * Part E: No prior treatment for metastatic NSCLC.
  8. * ECOG performance status of 0 or 1 at enrolment.
  9. * Life expectancy of ≥ 12 weeks at enrolment.
  10. * Have at least 1 measurable lesion per RECIST v1.1.
  11. * Adequate bone marrow, liver and kidney function
  1. * Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
  2. * 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)
  3. * Previous treatment with an anti-TIGIT therapy
  4. * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
  5. * Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
  6. * Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted).
  7. * Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4.
  8. * Symptomatic central nervous system (CNS) metastasis.
  9. * Thromboembolic event within 3 months prior to enrolment.
  10. * Other invasive malignancy within 2 years prior to screening.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Orange, California, 92868
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Baltimore, Maryland, 21201
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-14
Study Completion Date2028-03-16

Study Record Updates

Study Start Date2021-09-14
Study Completion Date2028-03-16

Terms related to this study

Keywords Provided by Researchers

  • TIGIT, Anti-TIGIT
  • PD-1, Anti-PD-1
  • NSCLC, Non-small Cell Lung Cancer
  • Advanced, Metastatic, Solid Tumor, Solid Tumour
  • Stage 3 NSCLC, Stage III NSCLC
  • Stage 4 NSCLC, Stage IV NSCLC
  • PD L1+ tumors

Additional Relevant MeSH Terms

  • Non-Small-Cell Lung Carcinoma