Phase Ib/II Study of M7824 in Combination with Chemotherapy in Stage IV Non-small Cell Lung Cancer
- Conditions
- Stage IV Non-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: 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
- EUCTR2018-004040-28-BE
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 64
1. Participants = 18 years of age inclusive at the time of signing the informed consent.
2. Are participants who have histologically confirmed diagnosis of Stage IV NSCLC.
a. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC.
b. Resolution of toxic effects of previous chemotherapy to Grade = 1 must be confirmed prior to enrollment
c. Participants who had disease progression on previous 1L treatment with PD (L)1 inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D.
d. Have measurable disease based on RECIST 1.1
e. Have a life expectancy of at least 3 months
f. Availability of archived tumor material (< 6 months old) adequate for biomarker analysis is mandatory at Screening, central laboratory confirmation is required. Fresh biopsies should be collected if archived tumor material is not available.
3. ECOG PS of 0 to 1 at study entry and date of first dose.
4. Other criteria may 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 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. The participant’s tumor harbors an EGFR sensitizing (activating) mutation, ROS1 rearrangement, BRAF V600E Mutation or is ALK positive, if targeted therapy is locally approved.
2. Mixed small cell with NSCLC cancer histology.
3. Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of > 30 Gy within 6 months prior to the first dose of study intervention.
4. Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years.
5. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the RT and have no evidence of new or enlarging brain metastases evaluated by Image, preferably brain MRI.
6. Active autoimmune disease that has required systemic treatment in the past 1 year (e.g. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), OR is receiving systemic steroid therapy < 3 days prior to the first dose of study intervention (M7824, cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, gemcitabine, or docetaxel) or receiving any other form of immunosuppressive medication.
7. Known severe hypersensitivity to study intervention or any components in their formulations.
8. For participants in Cohort A, B and C: Has received prior systemic therapy for Stage IV NSCLC, including 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).
9. Other criteria may 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