AK112 for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+76 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Summit Therapeutics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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)

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)

+8 more

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.

+11 more

Participant Groups

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.

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.