A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
PHASE3RECRUITING
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
Study details:
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Histologically or cytologically documented non-squamous NSCLC.
- Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
- Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
- Absence of documented tumor genomic mutation 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.
- Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
- At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
- Adequate organ and bone marrow function
Exclusion criteria
- Presence of small cell and neuroendocrine histology components.
- Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
- Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred > 12 months after the end of treatment.
- Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
- Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
- History of another primary malignancy except for 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.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- Active primary immunodeficiency/active infectious disease(s).
- Active tuberculosis infection.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06627647
Intervention or treatment
DRUG: Rilvegostomig
DRUG: Pembrolizumab
DRUG: Carboplatin
DRUG: Cisplatin
DRUG: Pemetrexed
Conditions
- Non-squamous Non-small Cell Lung Cancer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Research Site
Select from list below to view details:
Research Site
Darlinghurst, Australia
Research Site
Hyde Park, Australia
Research Site
Southport, Australia
Research Site
Wollongong, Australia
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Who is running the clinical trial?
A
AstraZeneca
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Arm A
| Drug: Rilvegostomig, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed |
ACTIVE_COMPARATOR: Arm B
| Drug: Pembrolizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as the time from randomization until the date of death due to any cause. | Up to approximately 5 years |
| Progression-free survival (PFS) | PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression). | Up to approximately 5 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Landmark overall survival (OS) rates | OS is defined as the time from randomization until the date of death due to any cause. | Up to approximately 5 years |
| Landmark progression-free survival (PFS) rates | PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression). | Up to approximately 5 years |
| Time to second progression or death (PFS2) | PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. | Up to approximately 5 years |
| Overall response rate (ORR) | ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1. | Up to approximately 5 years |
| Duration of response (DoR) | DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression). | Up to approximately 5 years |
| Pharmacokinetic (PK) of rilvegostomig | Concentration of rilvegostomig in serum | Up to approximately 5 years |
| Immunogenicity of rilvegostomig | Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig | Up to approximately 5 years |
| Patient-reported physical functioning | Proportion of participants with maintained or improved physical functioning as measured by PROMIS PF-SF 8c - 7 day at each time point. | Up to approximately 5 years |
| Patient-reported global health status (GHS)/quality of life (QoL) | TTD of GHS/QoL as measured by the EORTC IL172. TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold. | Up to approximately 5 years |
| Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) | TTD in pulmonary symptoms as measured by the NSCLC-SAQ. TTD is defined as time from randomization to the date of first deterioration. | Up to approximately 5 years |
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References
Clinical Trials Gov: A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLCOther trials to consider
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