NCT03337698

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

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-12-27
• Primary completion: 2025-10-14
• Completion: 2025-11-25
• First posted: 2017-11-09
• Last updated: 2025-12-12

Locations

29 sites across 7 countries: United States, Australia, France, Israel, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study