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

Gilead Sciences

Status and phase: Enrolling; Phase 2

Conditions: Advanced Non-Small Cell Lung Cancer

Treatments: Drug: Docetaxel; Drug: Platinum-Based Doublet; Drug: Domvanalimab; 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)

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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: Quemliclustat

Drug: Zimberelimab

B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy

Experimental group

Description:

Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Treatment:

Drug: Quemliclustat

Drug: Zimberelimab

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: Quemliclustat

Drug: Zimberelimab

Drug: Domvanalimab

Drug: Platinum-Based Doublet

C1: Quemliclustat + Zimberelimab + Docetaxel

Experimental group

Description:

Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion

Treatment:

Drug: Quemliclustat

Drug: Zimberelimab

Drug: Docetaxel

C2: Domvanalimab + Zimberelimab + Docetaxel

Experimental group

Description:

Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion

Treatment:

Drug: Quemliclustat

Drug: Domvanalimab

Drug: Docetaxel