A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)
- Conditions
- on-small cell lung cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001267-21-FR
- Lead Sponsor
- F. Hoffman-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
- Age >= 18 years
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy >= 3 months
- Histologically or cytologically confirmed metastatic, non-squamous or squamous NSCLC
- For patients in Cohort 1: no prior systemic therapy for metastatic NSCLC
- For patients in Cohort 2: disease progression during or following treatment for metastatic NSCLC that consisted of a platinum-containing regimen and a Programmed death-ligand 1(PD-L1)/PD-1 checkpoint inhibitor, given in combo as one line of therapy or as two separate lines of therapy for a maximum of two prior lines of systemic therapy
- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
- For patients in Cohort 1: High tumor PD-L1 expression
Stage 1 and 2
- Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1
- Adequate hematologic and end-organ function
- Negative HIV, hepatitis B surface antigen test at screening
- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus DNA test at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- Tumor accessible for biopsy
- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures as outlined for each specific treatment arm
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 195
- Activating mutation in the epidermal growth factor receptor gene or anaplastic lymphoma kinase gene rearrangement
- Prior allogeneic stem cell or solid organ transplantation
- Symptomatic, untreated, or actively progressing central nervous system metastases
- History of malignancy other than NSCLC within 2 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): 1. Objective response rate;Timepoint(s) of evaluation of this end point: 1. As defined in the study protocol;Secondary Objective: Stage 1:<br>To evaluate the efficacy of immunotherapy-based treatment combinations based on progression free survival (PFS), overall survival (OS) after randomization and at specific time points, duration of response (DOR) and disease control<br><br>Stage 1 and 2:<br>•To evaluate the safety of immunotherapy-based treatment combinations<br>•To characterize the pharmacokinetic profile of drugs that are administered as part of an immunotherapy-based treatment combinations<br>•To evaluate the immune response to drugs that are administered as part of an immunotherapy-based treatment combinations<br>;Main Objective: Stage 1:<br>To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Stage 1<br>1. PFS<br>2. OS<br>3. DOR<br>4. Disease control rate<br>5. OS at specific time points<br>Stage 1 and 2<br>6. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 <br>7. Change from baseline in vital signs, electrocardiogram parameters and targeted clinical laboratory test results<br>8. Plasma or serum concentration of each drug at specified timepoints<br>9. For drugs for which anti-drug antibody (ADA) formation is measured: presence of ADAs during the study relative to the presence of ADAs at baseline;Timepoint(s) of evaluation of this end point: Stage 1<br>1-5. As defined in the study protocol<br>Stage 1 and 2<br>6-9. As defined in the study protocol<br>