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TERMINATED
NCT03337698
PHASE1/PHASE2

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

Official title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

314

Start Date

2017-12-27

Completion Date

2025-11-25

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.

DRUG

Cobimetinib

Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.

DRUG

RO6958688

Cycle 1: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage. Subsequent cycles: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.

DRUG

Docetaxel

Docetaxel is administered by IV on Day 1 of each 21 day cycle.

DRUG

CPI-444

CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.

DRUG

Pemetrexed

Pemetrexed is administered by IV on Day 1 of a 21 day cycle.

DRUG

Carboplatin

Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.

DRUG

Gemcitabine

Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.

DRUG

Linagliptin

Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.

DRUG

Tocilizumab

Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.

DRUG

Ipatasertib

Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.

DRUG

Bevacizumab

Bevacizumab is administered by IV on Day 1 of each 21-day cycle.

DRUG

Sacituzumab Govitecan

Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.

OTHER

Radiation

Radiotherapy up to 21 days

DRUG

Evolocumab

Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.

DRUG

Tiragolumab

Tiragolumab is administered on Day 1 of each 21 day cycle.

DRUG

XL092

XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.

DRUG

Camonsertib

Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.

Locations (29)

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, United States

Columbia University Medical Center

New York, New York, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Blacktown Hospital

Blacktown, New South Wales, Australia

Peter Mac Callum Cancer Center

East Melbourne, Victoria, Australia

Centre Georges Francois Leclerc

Dijon, France

Centre Léon Bérard

Lyon, France

Hopital de la Timone

Marseille, France

Institut Régional du Cancer de Montpellier

Montpellier, France

Institut De Cancerologie De L'Ouest

Saint-Herblain, France

Institut Universitaire du Cancer de Toulouse-Oncopole

Toulouse, France

Rambam Medical Center

Haifa, Israel

Rabin Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

Songpa-gu, South Korea

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Fundación Jimenez Díaz

Madrid, Spain

Hospital Universitario HM Sanchinarro-CIOCC

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Barts Cancer Institute

London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom