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
Qualifiers
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
Treatments tested in this trial
- Rilvegostomig
- Ramucirumab
- Dato-DXd
Treatment groups
278 Participants
are divided into 3 treatment groupsLocations
83Australia
Research Site3084, Heidelberg Australia
Research Site6009, Nedlands Australia
Research Site5011, Woodville Australia
Canada
Research SiteM5G 2M9, TorontoOntario, Canada
Sponsors and collaborators
AstraZeneca
Lead sponsor
Daiichi Sankyo
Collaborator
Source ClinicalTrials.gov