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

Conditions

• Advanced or Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Nov 24, 2025

Status verified

Apr 2026

Primary completion

Feb 23, 2029

Completion

Feb 23, 2029

Study Design

Enrollment

152 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Sub study 2 Part A: Safety run-in
  Participants with squamous and non-squamous NSCLC will receive combination therapy of rilvegostomig, ramucirumab, and platinum-based chemotherapy to assess the safety and tolerability of this regimen.
• Experimental: Sub study 2 Part B: Dose expansion
  Participants will be randomised 1:1 into one of 2 treatment arms (rilvegostomig + chemotherapy + ramucirumab OR rilvegostomig + chemotherapy) in non-squamous histology cohorts and into a single arm (rilvegostomig + chemotherapy+ ramucirumab) in squamous histology cohorts.

Primary Outcome Measure

Part A and Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Approximately 46 months ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (10)

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