NCT06996782

A Platform Study in Non-Small Cell Lung Cancer (NSCLC)

A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 The originally planned Sub-study 1 was withdrawn (cancelled) and will not be conducted. Sub-study 2 will evaluate the safety, tolerability, and anti-tumour activity of rilvegostomig plus standard of care (SoC) platinum-based chemotherapy, with or without ramucirumab.

Conditions

• Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Rilvegostomig	Rilvegostomig will be administered as an intravenous (IV) infusion.
DRUG	Cisplatin	Cisplatin will be administered as SoC as an IV infusion.
DRUG	Carboplatin	Carboplatin will be administered as SoC as an IV infusion.
DRUG	Pemetrexed	Pemetrexed will be administered as SoC as an IV infusion.
DRUG	Paclitaxel	Paclitaxel will be administered as SoC as an IV infusion.
DRUG	Nab-paclitaxel	Nab-paclitaxel will be administered as SoC as an IV infusion.
DRUG	Ramucirumab	Ramucirumab will be administered as an IV infusion.

Timeline

• Start date: 2025-11-24
• Primary completion: 2029-02-23
• Completion: 2029-02-23
• First posted: 2025-05-30
• Last updated: 2026-03-30

Locations

105 sites across 20 countries: United States, Belgium, Brazil, China, France, Georgia, Germany, Italy, Japan, Malaysia, Moldova, Netherlands, Peru, Poland, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study