A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Tigard, Oregon.

Sponsor
Hoffmann-La Roche
Study ID
NCT05170204
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alectinib — DRUG
    Participants will receive oral alectinib twice daily with food.
  • Entrectinib — DRUG
    Participants will receive oral entrectinib once daily, with or without food.
  • Durvalumab — DRUG
    Participants will receive durvalumab, IV Q4W.

Study Details

This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) NSCLC staging system.

Key Dates

Start date
Nov 1, 2022
Status verified
May 2026
Primary completion
Jun 16, 2030
Completion
Jun 16, 2030

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1: Anaplastic Lymphoma Kinase (ALK)-positive (Alectinib Arm)
    Participants will receive alectinib 600 milligrams (mg) orally twice daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first
  • Active Comparator: Cohort A1: ALK-positive (Durvalumab Arm)
    Participants will receive 1500 mg of intravenous (IV) durvalumab every 4 weeks (Q4W) until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first
  • Experimental: Cohort A2: ROS Proto-oncogene 1 (ROS 1)-positive (Entrectinib Arm)
    Participants will receive entrectinib 600 mg orally once daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first. Cohort A2 has been closed to enrollment.
  • Active Comparator: Cohort A2: ROS 1-positive (Durvalumab Arm)
    Participants will receive 1500 mg of IV durvalumab Q4W until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first Cohort A2 has been closed to enrollment.

Primary Outcome Measure

Progression-free Survival (PFS), as Determined by Blinded Independent Central Review (BICR) per Response Evaluation Criterial in Solid Tumors Version 1.1 (RECIST V1.1) [ Time Frame: From randomization to the first documented disease progression or death from any cause, whichever occurs first (up to 3 years) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Northwest Cancer Specialists, P.C.TigardOregon97223-
Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Tigard, OR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Northwest Cancer Specialists, P.C.· Tigard, ORHillman Cancer Center· Pittsburgh, PA

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