Phase 2
Completed N=70
M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT03840915 ↗Enrolled (actual)
70
Serious AEs
72.9%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With Dose-Limiting Toxicities (DLTs) — 1; 1; 0; 3 Participants
Summary
The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities (DLTs) |
1; 1; 0; 3 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
40; 9; 9; 12; 31; 5 | — |
| SECONDARY Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator (IRC) |
45.0; 66.7; 44.4; 16.7 | — |
| SECONDARY Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator |
5.0; 4.1; 5.4; 2.6 | — |
| SECONDARY Overall Survival (OS) |
11.4; 11.8; NA; 16.5 | — |
| SECONDARY Duration of Response (DOR) |
9.6; NA; 10.5; 3.4 | — |
| SECONDARY Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa |
— | — |
| SECONDARY Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa |
— | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Bintrafusp Alfa |
— | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp Alfa |
— | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Bintrafusp Alfa |
— | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Bintrafusp Alfa |
— | — |
| SECONDARY Terminal Elimination Half-Life (T1/2) of Bintrafusp Alfa |
— | — |
| SECONDARY Number of Participants With Positive Antidrug Antibodies (ADA) |
9; 3; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Participants greater than or equals to (>=) 18 years of age inclusive at the time of signing the informed consent
- Participants who have histologically confirmed diagnosis of Stage IV NSCLC:
- Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC
- Participants who had disease progression on previous treatment with Programmed death-ligand 1 (PD- L1) inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D, as long as therapy was completed at least 28 days of the first study intervention.
- Have measurable disease based on Response evaluation criteria in solid tumors (RECIST) 1.1
- Have a life expectancy of at least 3 months
- Availability of archived tumor material (less than [ 30 gray (Gy) within 6 months prior to the first dose of study intervention
- Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
- Has known active central nervous system (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 imaging, preferably brain magnetic resonance imaging (MRI)
- Known severe hypersensitivity to study intervention or any components in their formulations
- 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)
- Unable to tolerate computed tomography (CT) or MRI in the opinion of the Investigator and/or allergy to contrast material.
Data sourced from ClinicalTrials.gov (NCT03840915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.