AK112 for Non-Small Cell Lung Cancer

Recruiting at 76 trial locations

Overseen By Lori Styles, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Summit Therapeutics

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Small cell carcinoma, Squamous cell carcinoma, Active autoimmune disease, Severe infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

420 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 Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)

Will I have to stop taking my current medications?

The trial requires that you stop taking EGFR inhibitor therapy at least 2 weeks before the first dose, except for osimertinib, which should be stopped 7 days prior. Other medications, like nonspecific immunomodulatory therapy and certain Chinese medicines, also need to be stopped before starting the trial.

Eligibility Criteria

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.

Inclusion Criteria

At least 1 measurable noncerebral lesion according to RECIST v1.1

Expected survival ≥3 months

Ability to understand and voluntarily sign a written informed consent form (ICF)

Exclusion Criteria

Concurrent enrollment in another clinical study

Imaging showing tumor characteristics

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

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 maintenance treatment with AK112 or Placebo plus Pemetrexed 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

90 days after last dose

Treatment Details

Interventions

• AK112

Trial Overview 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.

Participant Groups

Group I: AK112 in combination with Pemetrexed and Carboplatin Experimental Treatment 1 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 Carboplatin Active Control 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

Industry 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