A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic non-squamous NSCLC

Study identifier:D702FC00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2024-515008-38-00

Will Be Recruiting

Official Title

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

Medical condition

Non-squamous Non-Small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Rilvegostomig, Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed

Sex

All

Estimated Enrollment

878

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 29 Nov 2024

Estimated Primary Completion Date: 14 May 2029

Estimated Study Completion Date: 25 Mar 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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 4 weeks prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure).
- 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.

No locations available

Arms	Assigned Interventions
Experimental: Arm A Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.	Drug: Rilvegostomig Administered as one intravenously (IV) on Day 1 of each 21-day cycle Other Name: AZD2936 Drug: Carboplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Other Name: Not applicable Drug: Cisplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Other Name: Not applicable Drug: Pemetrexed Administered as one intravenously (IV) on Day 1 of each 21-day cycle Other Name: Not applicable
Active Comparator: Arm B Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.	Drug: Pembrolizumab Administered as one intravenously (IV) on Day 1 of each 21-day cycle Other Name: Keytruda Drug: Carboplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Other Name: Not applicable Drug: Cisplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Other Name: Not applicable Drug: Pemetrexed Administered as one intravenously (IV) on Day 1 of each 21-day cycle Other Name: Not applicable

Arms

Assigned Interventions

Experimental: Arm A
Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.

Drug: Rilvegostomig
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Other Name: AZD2936

Drug: Carboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Other Name: Not applicable

Drug: Cisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Other Name: Not applicable

Drug: Pemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Other Name: Not applicable

Active Comparator: Arm B
Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

Drug: Pembrolizumab
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Other Name: Keytruda

Drug: Carboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Other Name: Not applicable

Drug: Cisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Other Name: Not applicable

Drug: Pemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Other Name: Not applicable

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic non-squamous NSCLC

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Estimated Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Contacts

Contact