RILVEGOSTOMIG for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Participant must be ≥ 18 years of age at the time of signing the ICF"}
• {"criterion_text":"- WHO/ECOG performance status of 0 or 1"}
• {"criterion_text":"- At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline."}
• {"criterion_text":"- Adequate bone marrow and organ function"}
• {"criterion_text":"- Life expectancy ≥ 12 weeks"}
• {"criterion_text":"- Provision of acceptable tumour tissue"}
• {"criterion_text":"- Specific for Sub-Study 1 and Sub-Study 2: Histologically or cytologically documented advanced or metastatic NSCLC"}
• {"criterion_text":"- Specific for Sub-Study 1 and Sub-Study 2: PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)"}
• {"criterion_text":"- Specific for Sub-Study 1 and Sub-Study 2: Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)"}

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Prior exposure to immune-mediated therapy"}
• {"criterion_text":"- History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation"}
• {"criterion_text":"- Any concurrent anti-cancer treatment."}
• {"criterion_text":"- Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention."}
• {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders"}
• {"criterion_text":"- Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia."}
• {"criterion_text":"- Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2."}
• {"criterion_text":"- Unstable brain metastases"}
• {"criterion_text":"- History of another primary malignancy."}
• {"criterion_text":"- Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV."}
• {"criterion_text":"- Uncontrolled or significant cardiac disease"}
• {"criterion_text":"- Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2."}

Primary endpoints

• {"endpoint_text":"- Number of participants with adverse events (AE) and serious adverse events (SAE)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Objective response rate (ORR)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Best Overall Response(BOR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in Target Lesion Tumor Size","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Disease Control Rate(DCR) at 12 Weeks","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration Of Response (DoR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall Survival(OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serum concentration","definition_or_measurement_approach":""}
• {"endpoint_text":"- Maximum plasma drug concentration (Cmax)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Immunogenicity of study interventions in participants receiving treatment","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

37

Number Of Sites

5

Number Of Participants

20

Italy

Earliest CTIS Part Ii Submission Date

02-04-2026

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

34

Number Of Sites

8

Number Of Participants

20

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes: 1,10,11,12,13,14,15 (Logistic management),2,3,4,5,6,7,8,9; contact: Clinicaltrial.Enquiries@parexel.com

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,14,15 (Logistic management),2,3,4,5,6,7,8,9","organisation_type":"Pharmaceutical company"}