Study on Neoadjuvant Durvalumab and Platinum-Based Chemotherapy Followed by Surgery or Chemoradiotherapy in Resectable or Borderline Resectable Stage IIB-IIIB Non-Small Cell Lung Cancer (NSCLC)

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05925530

Provider View

This clinical trial is testing the effectiveness and safety of using durvalumab with chemotherapy before surgery or chemoradiotherapy in patients with certain stages of non-small cell lung cancer (NSCLC) that can potentially be removed by surgery.

Patient Parameters

Program Overview

The study aims to evaluate how well durvalumab, combined with platinum-based chemotherapy, works as an initial treatment for patients with stage IIB-IIIB non-small cell lung cancer (NSCLC) that can be surgically removed or is borderline resectable. After this initial treatment, patients will either undergo surgery followed by more durvalumab or receive chemoradiotherapy and additional durvalumab to see if these approaches help control the cancer.

Description

This is a global Phase II study involving multiple centers, focusing on the safety and effectiveness of durvalumab combined with platinum-based chemotherapy given through an IV. The study is for patients with stage IIB-IIIB non-small cell lung cancer (NSCLC) that can potentially be removed by surgery.

Neoadjuvant Period A:

  • All participants will first receive two cycles of durvalumab and chemotherapy every three weeks.
  • A team of specialists will assess if the cancer can be surgically removed.

Neoadjuvant Period B:

  • Cohort 1: Patients eligible for surgery will receive one or two more cycles of the treatment every three weeks, followed by surgery.
  • Cohort 2: Patients whose tumors cannot be removed will receive chemoradiotherapy for about six weeks.

After these treatments, both groups will continue to receive durvalumab every four weeks until the cancer progresses, returns, or for up to one year.

Eligibility Criteria

Inclusion Criteria

  • Cancer that can potentially be removed by surgery, confirmed by a team of specialists.
  • Newly diagnosed and confirmed stage IIB to certain stage IIIB NSCLC.
  • Cancer spread to lymph nodes confirmed by specific scans and biopsies.
  • Mandatory brain MRI.
  • No specific genetic mutations (EGFR and ALK wild-type).
  • Medically fit for surgery with good heart and lung function.
  • Aged 18 or older.
  • Confirmed diagnosis of NSCLC.
  • Expected to live at least 12 more weeks.
  • Weigh at least 30 kg.
  • Agree to use contraception if of childbearing potential.
  • Negative pregnancy test for women who can become pregnant.

Exclusion Criteria

  • Cancer that cannot be surgically removed, confirmed by specialists.
  • Stage IIIC cancer.
  • Planned wedge resection surgery.
  • Known genetic mutations (EGFR or ALK).
  • Not fit for surgery due to other health conditions.
  • Allergic to the study drugs.
  • More than one primary tumor.
  • Active hepatitis infection or positive for certain hepatitis markers.
  • Pregnant or breastfeeding women.
  • Investigator's judgment that participation is not suitable.
  • Previously infected or tested positive for HIV.

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