A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be ≥ 18 years of age at the time of signing the ICF
WHO/ECOG performance status of 0 or 1
At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
Adequate bone marrow and organ function
Disqualifiers
As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
Active or prior documented autoimmune or inflammatory disorders
Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
Trial design
Design model
Sequential
Treatments tested in this trial
Rilvegostomig
DrugRilvegostomig will be administered as IV infusion.
Ramucirumab
DrugRamucirumab will be administered as IV infusion.
Dato-DXd
DrugDato-DXd will be administered as IV infusion.
Treatment groups
278 Participants
are divided into 3 treatment groupsGroup A: Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%Experimental treatment 2 interventions
Group B: Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%Experimental treatment 2 interventions
Group C: Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLCExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AE) and serious adverse events (SAE)
To assess the safety and tolerability
Time frame
Through study completion, an average of 3 years2
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1
Time frame
Through study completion, an average of 3 yearsSecondary outcomes
1
Best Overall Response(BOR)
BOR is the best response a participant has had following randomisation/start of dosing, but prior to starting any subsequent cancer therapy and up to and including RECIST progression or the last evaluable assessment in the absence of RECIST progression
Time frame
Through study completion, an average of 3 years2
Change in Target Lesion Tumor Size
The best percentage change from baseline in Target Lesion tumour size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST 1.1 assessments
Time frame
Through study completion, an average of 3 years3
Progression free survival (PFS)
PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression) per RECIST 1.1.
Time frame
Through study completion, an average of 3 years4
Disease Control Rate(DCR) at 12 Weeks
DCR at 12 weeks is defined as the percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 11 weeks after start of treatment (to allow for an early assessment within the assessment window).
Time frame
From Day 1 pre-dose to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
AstraZeneca
Lead sponsor
Daiichi Sankyo
Collaborator
Source ClinicalTrials.gov