A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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
• Life expectancy ≥ 12 weeks
• Provision of acceptable tumour tissue Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
• Histologically or cytologically documented advanced or metastatic NSCLC
• PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
• Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs) Specific Inclusion Criteria for Sub-Study 3:
• Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
• Documented positive AGA and had progressed on prior targeted therapy

🚫 You may not be able to join if…

• 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
• Unstable brain metastases
• History of another primary malignancy.
• Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
• Uncontrolled or significant cardiac disease
• Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
• Prior exposure to immune-mediated therapy
• History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
• Any concurrent anti-cancer treatment.
• Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.

Where this trial is running

• Research Site, Santa Monica, California, United States
• Research Site, Santa Rosa, California, United States
• Research Site, Atlanta, Georgia, United States
• Research Site, Baltimore, Maryland, United States
• Research Site, Houston, Texas, United States
• Research Site, Fairfax, Virginia, United States
• Research Site, Heidelberg, Australia
• Research Site, Nedlands, Australia
• Research Site, Woodville, Australia
• Research Site, Toronto, Ontario, Canada
• Research Site, Changsha, China
• Research Site, Chengdu, China

+ 71 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07098338.