A global study of volrustomig (MEDI5752) plus chemotherapy versus pembrolizumab plus chemotherapy for participants with metastatic non-small cell lung cancer.
- Conditions
- Metastatic Non-Small Cell Lung Cancer (mNSCLC)MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503298-39-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 916
Histologically or cytologically documented squamous or non-squamous NSCLC. Stage IV NSCLC (according to Version 8 of the IASLC Staging, Provision of tumor sample for prospective PD-L1 testing ., PD-L1 <50%., Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK and ROS1 rearrangements., Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes (eg, NTRK, BRAF, RET, MET, etc.) for which there are locally approved targeted first-line therapies.
Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes (eg, NUT carcinoma, thoracic SMARCA4-deficient undifferentiated tumor, adenoid cystic carcinoma, epithelial-myoepithelial carcinoma) are excluded., No prior exposure to immunotherapy., No medical contraindication to platinum-based treatment., Spinal cord compression., 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 whole brain radiotherapy and study enrollment., History of another primary malignancy except for: (a) Malignancy treated with curative intent with no known active disease = 2 years before the first dose of study intervention and of low potential risk for recurrence. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease., As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS when compared with pembrolizumab plus chemotherapy in participants with mNSCLC where PD-L1 < 1%.;Secondary Objective: The secondary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS in patients with mNSCLC where PD-L1 < 50% when compared with pembrolizumab plus chemotherapy.;Primary end point(s): Progression-Free Survival (PFS) in PD-L1 <1% (using BICR assessments according to RECIST 1.1); PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants where PD-L1 <1%., Overall Survival (OS) in PD-L1 <1%; OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants where PD-L1 < 1%.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall survival in all randomized patients;Secondary end point(s):Progression Free Survival in all randomized participants.