Study on Pre-Surgery and Post-Surgery Treatment for Resectable Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT05061550

Provider View

This clinical trial is testing the safety and effectiveness of different combinations of medications given before and after surgery to treat early-stage non-small cell lung cancer that can be surgically removed.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of using the drug Durvalumab in combination with other medications like Oleclumab, Monalizumab, AZD0171, Volrustomig, or Datopotamab Deruxtecan (Dato-DXd) along with chemotherapy. These treatments are given before and after surgery to help control early-stage non-small cell lung cancer that can be removed by surgery.

Description

This study involves several treatment groups, each receiving a different combination of medications before and after surgery:

  • Group 1: Participants will receive Oleclumab and Durvalumab with chemotherapy before surgery, and Oleclumab and Durvalumab after surgery.
  • Group 2: Participants will receive Monalizumab and Durvalumab with chemotherapy before surgery, and Monalizumab and Durvalumab after surgery.
  • Group 3: Participants will receive Volrustomig with chemotherapy before surgery, and Volrustomig after surgery.
  • Group 4: Participants will receive Datopotamab Deruxtecan (Dato-DXd) and Durvalumab with single-agent platinum chemotherapy before surgery, and Durvalumab after surgery.
  • Group 5: Participants will receive AZD0171 and Durvalumab with chemotherapy before surgery, and AZD0171 and Durvalumab after surgery.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with non-small cell lung cancer (NSCLC) that can be surgically removed (Stage IIA to Stage IIIB).
  • Good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Adequate organ and bone marrow function.
  • Provide a tumor sample to confirm specific cancer markers (PD-L1, EGFR, or ALK status).
  • Adequate lung function.

Exclusion Criteria

  • Have specific genetic mutations (EGFR or ALK) that affect treatment.
  • Have active or past autoimmune or inflammatory disorders.
  • Have uncontrolled health issues like high blood pressure, heart problems, bleeding disorders, or serious digestive issues.
  • Have a history of another type of cancer.
  • Have small-cell lung cancer or a mix of small-cell and non-small cell lung cancer.
  • Have a history of immune system deficiencies.
  • Have lung conditions like pneumonitis that required steroids or are currently present.
  • Have had pre-surgery radiation treatment.
  • Require certain types of lung surgery that may not be suitable for the study.
  • Have a specific heart rhythm issue (QTcF interval ≥ 470 ms).
  • Have medical reasons that prevent chemotherapy treatment.
  • Have moderate or severe heart disease.
  • Are receiving other cancer treatments or have had certain vaccines recently.
  • Have used immune therapies or certain investigational drugs before.
  • Are using immunosuppressive medications or have active infections like hepatitis or HIV.

Locations

FACILITYZIPCITYSTATE
Research Site72205Little RockArkansas
Research Site90095Los AngelesCalifornia
Research Site94611OaklandCalifornia
Research Site06510New HavenConnecticut
Research Site34994StuartFlorida
Research Site30501GainesvilleGeorgia
Research Site60637ChicagoIllinois
Research Site21201BaltimoreMaryland
Research Site21231BaltimoreMaryland
Research Site02215BostonMassachusetts

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