A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
AstraZeneca
Summary
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
Description
This is a multicentre, open-label study to evaluate the safety and efficacy of various combinations of study interventions in participants with advanced or metastatic NSCLC (mNSCLC). The study will include a sub-study (sub-study 2) focused on a specific treatment that may include 2 parts - 1. Part A consisting of one of more safety run-in cohorts to evaluate 2 or more dose levels to identify the recommended Phase 2 dose (RP2D) unless RP2D has been established then Part A will not be required; and 2. Part B consisting of one or more expansion cohorts. The originally planned Sub-study 1 was w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC. * Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible) is mandatory at screening. * Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter. * Minimum life expectancy of 12 weeks in the opinion of the investigator. * Adequate organ and marrow function. * Contraceptive use by male or female participants should be…
Interventions
- DrugRilvegostomig
Rilvegostomig will be administered as an intravenous (IV) infusion.
- DrugCisplatin
Cisplatin will be administered as SoC as an IV infusion.
- DrugCarboplatin
Carboplatin will be administered as SoC as an IV infusion.
- DrugPemetrexed
Pemetrexed will be administered as SoC as an IV infusion.
- DrugPaclitaxel
Paclitaxel will be administered as SoC as an IV infusion.
- DrugNab-paclitaxel
Nab-paclitaxel will be administered as SoC as an IV infusion.
- DrugRamucirumab
Locations (104)
- Research SitePhoenix, Arizona
- Research SiteSanta Rosa, California
- Research SiteJacksonville, Florida
- Research SiteBaltimore, Maryland
- Research SiteDetroit, Michigan
- Research SiteRochester, Minnesota