Study on Durvalumab and Tremelimumab with Chemotherapy Compared to Pembrolizumab with Chemotherapy for Metastatic Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06008093

Provider View

This clinical trial is comparing two treatment combinations for patients with metastatic non-small cell lung cancer (NSCLC) that has specific genetic mutations. The study aims to find out which combination is more effective in controlling the cancer.

Patient Parameters

Program Overview

The purpose of this study is to see if a combination of the drugs durvalumab and tremelimumab with chemotherapy works better than the current standard treatment of pembrolizumab with chemotherapy for patients with metastatic non-small cell lung cancer (NSCLC) that has certain genetic mutations. These mutations include STK11, KEAP1, or KRAS. The study will involve 280 participants who will be randomly assigned to receive one of the two treatment combinations. Researchers will monitor how long patients live, how long they live without their cancer getting worse, and how their tumors respond to the treatments.

Description

This trial is designed to find out if a new combination of drugs, durvalumab and tremelimumab with chemotherapy, is safe and effective compared to the standard treatment of pembrolizumab with chemotherapy for people with metastatic non-small cell lung cancer (NSCLC) that has specific genetic mutations.

Participants will be randomly divided into two groups: one group will receive durvalumab and tremelimumab with chemotherapy, and the other group will receive pembrolizumab with chemotherapy. The chemotherapy will include either pemetrexed with cisplatin or pemetrexed with carboplatin. All treatments are given through an IV infusion.

This is an open-label trial, meaning both the participants and the doctors will know which treatment is being given. The study will measure how long participants live, how long they live without their cancer worsening, how their tumors respond, and how long these responses last. Researchers will also track any medical issues participants experience during the trial.

Participants will be in the study for up to 4 years, visiting the trial site every 3 to 4 weeks for physical exams, treatment, and tests. They will stop receiving the trial treatment if it is no longer beneficial or if they choose to leave the study.

Eligibility Criteria

Inclusion Criteria

  • Have Stage IV non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • Have tumors with STK11, KEAP1, or KRAS mutations.
  • Tumors must not have certain other genetic changes (EGFR mutations or ALK fusions).
  • No previous chemotherapy or systemic therapy for metastatic NSCLC, unless it was more than 6 months ago.
  • No previous immune therapy within 12 months, except for certain cancer vaccines.
  • Be in good overall health with a performance status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Have at least one measurable tumor that can be accurately tracked.
  • Have adequate organ and bone marrow function.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control.
  • All participants and their partners must use contraception.
  • Weigh more than 30 kg.

Exclusion Criteria

  • Have uncontrolled diseases or a history of organ transplant.
  • Have mixed small cell and non-small cell lung cancer.
  • Have had major surgery within 28 days before starting the study.
  • Have active autoimmune or inflammatory disorders, with some exceptions.
  • Cannot tolerate platinum-based chemotherapy.
  • Have another active cancer, with some exceptions.
  • Have persistent side effects from previous cancer treatments, except for certain conditions.
  • Have certain heart conditions or uncontrolled heart issues.
  • Are receiving other cancer treatments or investigational drugs.
  • Have untreated brain metastases or other specific brain conditions.
  • Have active infections like tuberculosis, hepatitis, or uncontrolled HIV.
  • Are using immunosuppressive medications, with some exceptions.
  • Have received a live vaccine within 30 days before starting the study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.

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