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Anti-tumor antibiotic

AK112 for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Led By Li Zhang, Master

Research Sponsored by Summit Therapeutics

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

Have previously received 3rd generation EGFR-TKI treatment and have progressed on or following.

Must not have

Symptomatic central nervous system metastases.

The subject has received systemic anti-tumor therapy other than EGFR-TKI.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Pivotal Trial

Summary

This trial tests a new drug combo for lung cancer that has resisted other treatments.

Who is the study for?

This trial is for adults over 18 with advanced non-squamous NSCLC that has worsened after EGFR-TKI treatment. They must have good organ function, an ECOG score of 0 or 1, a life expectancy of at least three months, and agree to use contraception. Exclusions include other treatable gene mutations, recent treatments conflicting with the study drugs, symptomatic brain metastases, significant health issues within the last year, active severe diseases or participation in another clinical study.

What is being tested?

The trial tests Ivonescimab (AK112) plus chemotherapy against a placebo plus chemotherapy in patients whose lung cancer progressed after previous treatments. It's randomized and double-blind meaning neither participants nor researchers know who gets the real drug versus placebo until after results are analyzed.

What are the potential side effects?

Possible side effects of Ivonescimab may include reactions at the injection site, immune-related conditions due to its action on tumor immunity mechanisms (like inflammation), fatigue from chemotherapy combinations and potential digestive disturbances.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have taken a 3rd generation EGFR-TKI treatment and my cancer progressed after that.

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My cancer has EGFR mutations.

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My non-squamous NSCLC is at an advanced stage and cannot be treated with surgery, radiotherapy, or chemotherapy.

Exclusion Criteria

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

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I have brain metastases causing symptoms.

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I have received cancer treatment that is not EGFR-TKI.

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I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.

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I need frequent drainage for fluid buildup in my chest or abdomen.

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My tumor is affecting major blood vessels or nearby organs.

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My cancer is confirmed as small cell or mainly squamous cell carcinoma.

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I have received treatments that target my cancer's immune response.

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I have had a major illness within the last year.

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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 chest radiation therapy before starting this treatment.

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

Progression-free survival (PFS)

Secondary study objectives

DCR

DoR

+6 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

Placebo Group

Group I: Ivonescimab (SMT112 or AK112) in combination with Pemetrexed and CarboplatinExperimental Treatment1 Intervention

Subjects will receive Ivonescimab (SMT112 or 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 CarboplatinPlacebo Group1 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 / 14Eligibility criteria met