Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer (EDGE-Lung)

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Arcus Biosciences

Status and phase

Enrolling
Phase 2

Conditions

Advanced Non-Small Cell Lung Cancer

Treatments

Drug: Platinum-Based Doublet
Drug: Domvanalimab
Drug: Docetaxel
Drug: Zimberelimab
Drug: Quemliclustat

Study type

Interventional

Funder types

Industry

Identifiers

NCT05676931
EDGE-Lung
2022-502916-35-00 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.

Enrollment

320 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
  • At least one measurable target lesion per RECIST v1.1.
  • Adequate organ and marrow function
  • Participants must be willing to provide adequate tumor tissue

Exclusion criteria

  • Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
  • Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
  • Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded).
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

320 participants in 8 patient groups

A1: Domvanalimab + Zimberelimab
Experimental group
Description:
Domvanalimab and Zimberelimab, both administered by IV infusion
Treatment:
Drug: Zimberelimab
Drug: Domvanalimab
A2: Domvanalimab + Zimberelimab
Experimental group
Description:
Domvanalimab and Zimberelimab, both administered by IV infusion
Treatment:
Drug: Zimberelimab
Drug: Domvanalimab
A3: Quemliclustat + Zimberelimab
Experimental group
Description:
Quemliclustat and Zimberelimab, both administered by IV infusion
Treatment:
Drug: Zimberelimab
Drug: Quemliclustat
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Experimental group
Description:
Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Treatment:
Drug: Zimberelimab
Drug: Quemliclustat
Drug: Platinum-Based Doublet
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Experimental group
Description:
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Treatment:
Drug: Zimberelimab
Drug: Domvanalimab
Drug: Platinum-Based Doublet
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Experimental group
Description:
Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Treatment:
Drug: Zimberelimab
Drug: Quemliclustat
Drug: Domvanalimab
Drug: Platinum-Based Doublet
C1: Quemliclustat + Zimberelimab + Docetaxel
Experimental group
Description:
Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
Treatment:
Drug: Zimberelimab
Drug: Quemliclustat
Drug: Docetaxel
C2: Domvanalimab + Zimberelimab + Docetaxel
Experimental group
Description:
Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
Treatment:
Drug: Quemliclustat
Drug: Docetaxel
Drug: Domvanalimab

Trial contacts and locations

0

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Central trial contact

Arcus Biosciences

Data sourced from clinicaltrials.gov

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