Study identifier:D702KC00001
ClinicalTrials.gov identifier:NCT06996782
EudraCT identifier:N/A
CTIS identifier:2024-519786-22-00
A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer
Advanced or Metastatic Non-Small Cell Lung Cancer
Phase 1/2
No
Rilvegostomig, AB248, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel, Ramucirumab
All
182
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sub study 1 Part A: Safety run-in Participants will receive AB248 in combination with rilvegostomig to identify the RP2D to futher evaluate the combination in Part B. | Drug: Rilvegostomig Rilvegostomig will be administered as an intravenous (IV) infusion. Other Name: AZD2936 Drug: AB248 AB248 will be administered via syringe or an IV bag. |
Experimental: Sub study 1 Part B: Dose expansion Participants with squamous and non-squamous NSCLC (programmed death-ligand 1 [PD-L1] ≥ 50% and PD-L1 1-49%) will receive AB248 in combination with rilvegostomig based on the RP2D determined in Part A. | Drug: Rilvegostomig Rilvegostomig will be administered as an intravenous (IV) infusion. Other Name: AZD2936 Drug: AB248 AB248 will be administered via syringe or an IV bag. |
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. | Drug: Rilvegostomig Rilvegostomig will be administered as an intravenous (IV) infusion. Other Name: AZD2936 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. |
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. | Drug: Rilvegostomig Rilvegostomig will be administered as an intravenous (IV) infusion. Other Name: AZD2936 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. |