AK112 for Non-Small Cell Lung Cancer

Recruiting at 78 trial locations

Overseen By Lori Styles, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Summit Therapeutics

Must not be taking: Immunotherapy, Chinese herbal

Disqualifiers: Small cell carcinoma, Other driver mutations, Active autoimmune, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

322 Participants Needed

Trial Summary

What is the purpose of this trial?

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have received certain treatments like EGFR-TKI, palliative local treatment, or non-specific immunomodulatory treatment within 2 weeks before starting the trial. Check with the trial team for more details.

Research Team

Li Zhang, MD

Principal Investigator

Sun Yat-sen University

Eligibility Criteria

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.

Inclusion Criteria

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

You are expected to live for at least 3 more months.

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

Exclusion Criteria

I have brain metastases causing symptoms.

I haven't had any cancer except for my current one or any cured local tumors in the past 3 years.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AK112 or Placebo combined with Pemetrexed and Carboplatin via intravenous infusion every 3 weeks, up to 4 cycles

12 weeks

4 visits (in-person)

Maintenance Treatment

Participants receive AK112 or Placebo combined with Pemetrexed for maintenance treatment every 3 weeks, up to 2 years

up to 2 years

Regular visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

• AK112 Injection
• Placebo Injection

Trial Overview 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.

Participant Groups

Group I: Ivonescimab (SMT112 or AK112) in combination with Pemetrexed and Carboplatin Experimental Treatment 1 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 Carboplatin Placebo Group 1 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.

Who Is Running the Clinical Trial?

Summit Therapeutics

Lead Sponsor

Trials

18

Recruited

4,500+

Akeso

Lead Sponsor

Trials

122

Recruited

23,400+

Dr. Simon Williams

Akeso

Chief Executive Officer since 2022

PhD in Organic Chemistry from Cambridge University

Dr. Baiyong Li

Akeso

Chief Medical Officer

MD from an unspecified institution