1L NSCLC Phase II RCT M7824 vs Pembrolizumab

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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