Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT04396535
Status:
TERMINATED
Last Update Posted:
2025-11-17
First Post:
2020-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Randomized Phase II Study of Standard Chemotherapy With Docetaxel With or Without Bintrafusp Alfa in Patients With Advanced NSCLC After Progressing on a Combination of Anti-PD-1/PD-L1 Agents and Chemotherapy
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
EMD Serono recommendation based on three other studies that failed to show benefit for bintrafusp alfa
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well docetaxel works with or without bintrafusp alfa in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Chemotherapy drugs, such as docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with bintrafusp alfa, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving docetaxel and bintrafusp alfa in combination may work better in treating non small-cell lung cancer compared to docetaxel alone.
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare the progression-free survival (PFS) of bintrafusp alfa in combination with docetaxel versus (vs) docetaxel alone.
SECONDARY OBJECTIVES:
I. To evaluate overall survival of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
II. To evaluate overall response rates of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
III. To evaluate duration of response of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
IV. To evaluate the safety of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
CORRELATIVE RESEARCH OBJECTIVES:
I. To evaluate PD-L1, TGF-beta, and TMB as potential predictive markers of clinical response in tumor biopsies and in plasma.
II. To evaluate biomarkers associated with inhibition of TGF-beta and PD-L1. III. To evaluate the changes in immune system using mass cytometry in response to TGF-beta and PD-L1 inhibition.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 5 years.
I. To compare the progression-free survival (PFS) of bintrafusp alfa in combination with docetaxel versus (vs) docetaxel alone.
SECONDARY OBJECTIVES:
I. To evaluate overall survival of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
II. To evaluate overall response rates of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
III. To evaluate duration of response of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
IV. To evaluate the safety of bintrafusp alfa in combination with docetaxel vs docetaxel alone.
CORRELATIVE RESEARCH OBJECTIVES:
I. To evaluate PD-L1, TGF-beta, and TMB as potential predictive markers of clinical response in tumor biopsies and in plasma.
II. To evaluate biomarkers associated with inhibition of TGF-beta and PD-L1. III. To evaluate the changes in immune system using mass cytometry in response to TGF-beta and PD-L1 inhibition.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: