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OncoMatch/Clinical Trials/NCT06868277

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

Is NCT06868277 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Rilvegostomig and Pembrolizumab for carcinoma, non-small cell lung.

Phase 3RecruitingAstraZenecaNCT06868277Data as of Jun 2026Location: International · 27 countries

Treatment: Rilvegostomig · PembrolizumabThe purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

RilvegostomigPembrolizumab

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: EGFR wild-type

Required: ROS1 wild-type

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

WHO/ECOG 0–1

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).

Cannot have received: anti-TIGIT therapy

Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.

Cannot have received: anti-PD-1 therapy

Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.

Lab requirements

Blood counts

adequate bone marrow function

Kidney function

Liver function

Adequate organ and bone marrow function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Newark, Delaware
  • Research Site · Bay Pines, Florida
  • Research Site · Clearwater, Florida
  • Research Site · St. Petersburg, Florida
  • Research Site · Marietta, Georgia

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06868277 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ALK?

Yes, ALK wild-type is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR wild-type is a required biomarker for enrollment.

Does this trial require ROS1?

Yes, ROS1 wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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