Phase III Study of AK112 for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Summit Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06396065

Provider View

This clinical trial is testing a new treatment, AK112, combined with chemotherapy drugs, for patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have specific genetic mutations and have not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if the drug AK112, when combined with chemotherapy drugs pemetrexed and carboplatin, can help treat patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has specific genetic mutations and has progressed after previous treatments. The trial will involve about 420 participants who will be randomly assigned to receive either the new treatment or a placebo, along with the chemotherapy drugs. The treatment will be given in cycles, with the possibility of continuing for up to two years.

Description

This clinical trial is designed to compare the effects of a new drug, Ivonescimab (also known as AK112), combined with chemotherapy drugs pemetrexed and carboplatin, against a placebo combined with the same chemotherapy drugs. The study focuses on patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has specific genetic mutations and has not responded to previous treatments. Participants will be randomly assigned to one of two groups: one receiving the new drug combination and the other receiving a placebo. The treatment will be administered through an intravenous infusion every three weeks, up to four cycles, followed by maintenance treatment with Ivonescimab or placebo plus pemetrexed for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign a consent form.
  • Aged 18 to 75 years (no upper age limit for North America and Europe).
  • Good overall health with a performance status score of 0 or 1.
  • Expected to live at least 3 more months.
  • Diagnosed with advanced non-squamous NSCLC that cannot be surgically removed or treated with radiation.
  • Have specific EGFR genetic mutations confirmed by tests.
  • Previously treated with EGFR TKI and experienced treatment failure.
  • Have at least one measurable tumor outside the brain.
  • Have adequate organ function based on medical tests.
  • Women of childbearing age must have a negative pregnancy test and use effective contraception.
  • Men must use effective contraception if their partner is of childbearing potential.

Exclusion Criteria

  • Have a type of lung cancer other than non-squamous NSCLC.
  • Previously treated with certain immune therapies.
  • Received more than one prior line of chemotherapy for advanced NSCLC.
  • Participating in another clinical study with certain conditions.
  • Recently treated with EGFR inhibitors or certain other therapies.
  • Tumor is in a location that poses a high risk, such as near major blood vessels or organs.
  • Have active brain metastases causing symptoms.
  • Have had another type of cancer within the last 3 years.
  • Have an active autoimmune disease requiring treatment.
  • Have a history of major gastrointestinal issues.
  • Have received significant radiation therapy recently.
  • Have received a live vaccine recently or plan to during the study.
  • Have had a severe infection recently.

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