Status:

RECRUITING

Volrustomig Priming Regimens Exploratory Phase II Platform Study

Lead Sponsor:

AstraZeneca

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

18-130 years

Phase:

PHASE2

Brief Summary

Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with spe...

Detailed Description

This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types. This plat...

Eligibility Criteria

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration.
  • Life expectancy greater than or equal to (>=) 12 weeks.
  • Adequate organ and bone marrow function.
  • Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
  • Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2.
  • Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
  • Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
  • At least one measurable lesion not previously irradiated that can be accurately measured at baseline as >= 10 millimeter (mm) in the longest diameter.

Key Exclusion Criteria:

  • Spinal cord compression.
  • History of primary active immunodeficiency.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
  • Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.
  • Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (>) 12 months from end of last therapy.

Key Trial Info

Start Date :

August 27 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2027

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT06448754

Start Date

August 27 2024

End Date

July 30 2027

Last Update

April 13 2026

Active Locations (77)

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Page 1 of 20 (77 locations)

1

Research Site

Los Angeles, California, United States, 90067

2

Research Site

Grand Junction, Colorado, United States, 81501

3

Research Site

Wheat Ridge, Colorado, United States, 80033

4

Research Site

Baltimore, Maryland, United States, 21231