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Anti-metabolites

AK112 for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by Summit Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent

ECOG performance status score of 0 or 1

Must not have

Histologic or cytopathologic evidence of small cell carcinoma component or predominantly squamous cell carcinoma

Received immune checkpoint inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Pivotal Trial

Summary

"This trial is testing a new drug, AK112, in combination with standard chemotherapy in patients with a specific type of lung cancer who have not responded to previous treatments."

Who is the study for?

This trial is for adults with advanced non-squamous NSCLC that has worsened after EGFR-TKI treatment. Participants must be in good physical condition, have measurable cancer, and acceptable organ function. They can't join if they've had certain other cancers, serious heart conditions, immune diseases or lung issues unrelated to their cancer.

What is being tested?

The study tests AK112 injection versus a placebo. Both are given alongside standard chemotherapy drugs Pemetrexed and Carboplatin. It's randomized and double-blind, meaning neither the patients nor doctors know who gets AK112 or the placebo.

What are the potential side effects?

Possible side effects of AK112 may include typical reactions to immunotherapy such as fatigue, skin rash, diarrhea, liver inflammation and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I am fully active or can carry out light work.

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My lung cancer is advanced but not squamous type.

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My cancer has EGFR mutations confirmed by tests.

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I have been treated with EGFR inhibitors and my cancer did not respond.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is confirmed to be small cell or mostly squamous cell type.

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I have received treatments that boost my immune system.

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I have had chemotherapy, anti-angiogenic therapy, or more than one antitumor treatment.

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I have symptoms from cancer spread to my brain or spinal cord.

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I have not had any cancer other than non-small cell lung cancer in the past 3 years.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I have had serious illnesses before starting the treatment.

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I have recently had radiation therapy on my chest or another part of my body.

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I have not received any live vaccines in the last 4 weeks.

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I have not had a severe infection in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS) in the ITT population

Progression-free survival (PFS)

Secondary study objectives

DoR

Number of subjects who develop detectable anti-drug antibodies (ADAs)

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AK112 in combination with Pemetrexed and CarboplatinExperimental Treatment1 Intervention

Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

Group II: Placebo in combination with Pemetrexed and CarboplatinActive Control1 Intervention

Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

0 / 15Eligibility criteria met