Volrustomig Priming Regimens Exploratory Phase II Platform Study
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06448754
This Phase II study evaluates volrustomig with chemotherapy in treatment-naïve Stage IV NSQ NSCLC patients. Participants are randomized into two arms, receiving volrustomig, carboplatin, and pemetrexed. Eligibility includes ECOG 0-1, life expectancy ≥12 weeks, adequate organ function, and absence of specific genetic mutations. Participants must have measurable lesions.
Patient Parameters
| Parameter | Options |
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Program Overview
Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.
Description
This is a platform, randomized, open-label, multicenter, global study.
Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease.
These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B.
Both arms will test a volrustomig dosing in combination with chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration.
- Life expectancy greater than or equal to (>=) 12 weeks.
- Adequate organ and bone marrow function.
- Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
- Histologically or cytologically documented NSQ NSCLC.
- Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
- Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
- At least one measurable lesion not previously irradiated that can be accurately measured at baseline as >= 10 millimeter (mm) in the longest diameter.
Key
Exclusion Criteria
- Spinal cord compression.
- History of primary active immunodeficiency.
- Active or prior documented autoimmune or inflammatory disorders.
- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
- Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.
- Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred greater (>) 12 months from end of last therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 90067 | Los Angeles | California |
| Research Site | 81501 | Grand Junction | Colorado |
| Research Site | 80033 | Wheat Ridge | Colorado |
| Research Site | 21231 | Baltimore | Maryland |
| Research Site | 48202 | Detroit | Michigan |
| Research Site | 27514 | Chapel Hill | North Carolina |
| Research Site | 98405 | Tacoma | Washington |
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