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ACTIVE NOT RECRUITING Phase 3

Phase III Study of AK112 for NSCLC Patients

NCT06396065 · View on ClinicalTrials.gov ↗

Study Summary

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)

Interventions

  • DRUG Placebo Injection
  • DRUG AK112 Injection

Study Locations (20)

California

  • CBCC Global Research — Bakersfield
  • UC San Diego — La Jolla
  • University of Southern California — Los Angeles
  • Valkyrie Clinical Trials — Los Angeles
  • UCLA Department of Medicine - Hematology/Oncology — Los Angeles
  • Palo Alto Medical Foundation Research Institute — Mountain View
  • Providence St. Joseph — Orange
  • UC Irvine — Orange
  • Sutter Cancer center — Sacramento
  • UC DAVIS Comprehensive Cancer Center — Sacramento
  • Sharp Memorial Hospital — San Diego
  • California Pacific Medical Center — San Francisco
  • Providence Medical Foundation — Santa Rosa
  • Presbyterian Intercommunity Hospital — Whittier

Florida

  • The Oncology Institute of Hope & Innovation — Fort Lauderdale
  • University of Miami — Miami
  • Florida Cancer Associates - Ocala Oncology — Ocala
  • BRCR Global — Plantation
  • Florida Cancer Specialists - North — St. Petersburg

Colorado

  • Rocky Mountain Cancer Center — Lone Tree

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2023-05-04
Est. Completion 2026-12-31
Phase Phase 3

Sponsor

Summit Therapeutics

59 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06396065

The ClinicalTrials.gov registry entry for NCT06396065 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Summit Therapeutics, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-Squamous Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which Placebo Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06396065 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06396065 about?

NCT06396065 is a clinical study titled "Phase III Study of AK112 for NSCLC Patients". 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 Kina...

What is the current status of trial NCT06396065?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2023-05-04. Estimated completion is 2026-12-31.

What conditions does trial NCT06396065 study?

This clinical trial studies the following conditions: Non-Squamous Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06396065?

The interventions under investigation include: Placebo Injection (DRUG), AK112 Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06396065?

This trial is sponsored by Summit Therapeutics, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06396065 being conducted?

This trial has 20 study locations across California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial