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

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).

Conditions

• Carcinoma, Non-Small-Cell Lung

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.

Sponsors & Collaborators

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-27

Primary Completion

2025-10-14

Completion

2025-11-25

FDA Drug

Yes

Countries

• United States
• Australia
• France
• Israel
• South Korea
• Spain
• United Kingdom

Study Locations