Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT04396535
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.
Study:
NCT04396535
Study Brief:
Protocol Section:
NCT04396535