Description:
The main purpose of the study is to evaluate the safety and tolerability of M7824 in
combination with chemotherapy.
Title
- Brief Title: M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
- Official Title: A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
MS200647_0024
- SECONDARY ID:
2018-004040-28
- NCT ID:
NCT03840915
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
Cisplatin | | Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 |
Carboplatin | | Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 |
Pemetrexed | | Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 |
Nab-paclitaxel | | Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824 |
Gemcitabine | | Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824 |
Docetaxel | | Cohort D: Docetaxel + M7824 |
M7824 | | Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 |
Carboplatin | | Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824 |
Carboplatin | | Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824 |
M7824 | | Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824 |
Paclitaxel | | Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824 |
Purpose
The main purpose of the study is to evaluate the safety and tolerability of M7824 in
combination with chemotherapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 | Experimental | | - Cisplatin
- Carboplatin
- Pemetrexed
- M7824
|
Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824 | Experimental | | - Nab-paclitaxel
- Carboplatin
- M7824
- Paclitaxel
|
Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824 | Experimental | | - Cisplatin
- Gemcitabine
- Carboplatin
- M7824
|
Cohort D: Docetaxel + M7824 | Experimental | | |
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:
1. Participants in Cohort A, B, and C must not have received prior systemic therapy
treatment for their Stage IV NSCLC
2. 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 [<] 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
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study
entry and date of first dose
Exclusion Criteria:
- The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing
(activating) mutation,ROS1 rearrangement, or BRAF V600E mutation or anaplastic
lymphoma kinase (ALK) positive, if targeted therapy is locally approved
- Mixed small cell with NSCLC cancer histology
- Has received major surgery within 4 weeks prior to the first dose of study
intervention; received thoracic radiation therapy (RT) of > 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Dose Limiting Toxicities (DLTs) |
Time Frame: | Day 1 to Day 21 (Cycle 1) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Confirmed Objective Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Concentration of M7824 Observed Immediately at the End of Infusion (Ceoi) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Concentration of M7824 Observed Immediately Before Next Dosing (Ctrough) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Area Under the Serum Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of M7824 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Maximum Observed Serum Concentration (Cmax) of M7824 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Time to Reach Maximum Serum Concentration (Tmax) of M7824 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Apparent Terminal Half-life (t1/2) of M7824 |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity of M7824, as Assessed by Anti-drug Anti-body (ADA) Assay |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
Trial Keywords
- Non-small Cell Lung Cancer
- Bintrafusp alfa (proposed INN)
- M7824
- Stage IV
- INTR@PID LUNG 024
Last Updated
February 16, 2021