EUCTR2018-001517-32-ESActive, not recruitingPhase 1
A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 versusPembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Merck KGaA
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. >= 18 years of age inclusive, at the time of signing the informed consent
- •2. histologically confirmed diagnosis of advanced NSCLC and:
- •a. Have not received prior systemic therapy treatment for their advanced/Stage IV
- •NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy,
- •and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy
- •was completed at least 6 months prior to the diagnosis of metastatic disease.
- •Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant
- •chemotherapy therapy to Grade = 1. For radiation toxicity or prior major surgeries,
- •participants should have recovered from side effects and/or complications.
- •b. Have measurable disease based on RECIST 1.1
- •c. Have a life expectancy of at least 3 months
- •d. Availability of either tumor archival material (< 6 months old) or fresh biopsies
- •collected within 28 days (excluding bone biopsies) before the first dose is mandatory
- •to determine PD-L1 expression level prior to enrollment
- •e. PD-L1 high status is required
- •(other protocol defined criteria could apply)
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
- •1. The participant’s tumor harbors an EGFR sensitizing (activating) mutation, ALK
- •translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is
- •locally approved
- •2. Has received major surgery within 4 weeks prior to the first dose of study intervention;
- •received thoracic RT of > 30 Gy within 6 months prior to the first dose of study
- •7. Known severe hypersensitivity reactions to mAB
- •8. Receipt of any organ transplantation
- •9. Has interstitial lung disease (ILD) OR has had a history of pneumonitis that has required
- •oral or IV steroids
- •10. Significant acute or chronic infections
- •11. Has a history or current evidence of any condition, therapy, or laboratory abnormality
- •that might confound the results of the study, interfere with participation for the full
- •duration of the study, or is not in the best interest of the participant, in the opinion of the
- •treating Investigator
- •12. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
- •anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
- •ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or
- •checkpoint pathways)
- •intervention.
- •13. Previous malignant disease
- •14. Has active CNS metastases causing clinical symptoms or metastases that require
- •therapeutic intervention and/or carcinomatosis meningitis
- •15. Active autoimmune disease that has required systemic treatment in past 1 year OR is
- •receiving systemic steroid therapy < 3 days prior to the first dose of study intervention or
- •receiving any other form of immunosuppressive medication.
- •16. Is expected to require any other form of systemic or localized antineoplastic therapy
- •while on study (including maintenance therapy with another agent for NSCLC, RT,
- •and/or surgical resection)
- •(other protocol defined criteria could apply)
Investigators
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