A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,160 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with a specific type of lung cancer that has spread and has specific characteristics. Participants will receive one of two treatments combined with chemotherapy as part of their first treatment plan.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with non-squamous non-small cell lung cancer.
I have stage III B/C or IV lung cancer that cannot be cured.
I do not have certain mutations in my tumor, like EGFR or ALK.
I have a tumor sample that shows a specific marker called PD-L1.
I have at least one tumor that can be measured in size.
My organs and bone marrow are functioning well.
You may not be able to join if
I have small cell or neuroendocrine lung cancer.
I have brain metastases unless they are stable and not requiring medication.
I have received prior treatment for my lung cancer that is not allowed.
I have taken immune therapy drugs targeting certain receptors before.
I have had another type of cancer that is active or might come back.
I have an autoimmune disease that requires ongoing treatment.
I have an active infectious disease or primary immunodeficiency.
I have an active tuberculosis infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically documented non-squamous NSCLC.
* Stage III B/C or IV NSCLC (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 a…
Inclusion Criteria:
* Histologically or cytologically documented non-squamous NSCLC.
* Stage III B/C or IV NSCLC (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 and available 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 NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred \> 12 months after the end of systemic therapy 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 systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.
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