Immunotherapy Combinations for Lung Cancer
(ARC-4 Trial)

Recruiting in Palo Alto (17 mi)

+49 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Arcus Biosciences, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or zimberelimab), in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).

Research Team

Medical Director

Principal Investigator

Arcus Biosciences, Inc.

Eligibility Criteria

This trial is for adults with advanced or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC) who have progressed on PD-1/-L1 therapy and haven't had chemotherapy. They must have a measurable lesion, good performance status, and no recent TKI therapy. Participants with specific genetic alterations in NSCLC who've exhausted targeted therapies can join but not those who've recently used certain drugs or have active autoimmune diseases.

Inclusion Criteria

I have a recent tissue sample from my tumor, not older than 24 months.

My organs and bone marrow are working well.

Arm B participants must fulfill one of the following:

See 13 more

Exclusion Criteria

I have not taken any medications that could interact with etrumadenant.

Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of etrumadenant, 90 days after the last dose of zimberelimab or pembrolizumab, or 6 months after the last dose of pemetrexed, whichever is longer

I haven't taken strong CYP3A4 affecting drugs in the last 4 weeks or 5 half-lives.

See 5 more

Treatment Details

Interventions

Carboplatin (Chemotherapy)
Etrumadenant (AB928) (Immunotherapy Combination)
Pembrolizumab (PD-1 Inhibitor)
Pemetrexed (Chemotherapy)
Zimberelimab (PD-1 Inhibitor)

Trial OverviewThe study tests the safety and effectiveness of etrumadenant combined with carboplatin and pemetrexed, plus an anti-PD-1 antibody (pembrolizumab or zimberelimab), in treating NSCLC. It's an early-phase trial to find the right dose and see how well patients respond to this combination treatment.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Dose Expansion Arm 2Experimental Treatment4 Interventions

The etrumadenant at RDE determined from the dose escalation phase will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen and zimberelimab in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.

Group II: Dose Expansion Arm 1Experimental Treatment3 Interventions

Zimberelimab will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.

Group III: Dose Escalation Arm BExperimental Treatment4 Interventions

Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer.

Group IV: Dose Escalation Arm AExperimental Treatment3 Interventions

Carboplatin is already approved in Canada for the following indications: