Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer

NCT04396535 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1821NCI-2020-0297519-010887
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) of Bintrafusp Alfa in Combination With Docetaxel Versus (vs) Docetaxel Alone

  The primary analysis of PFS will be a comparison of the Kaplan-Meier curves for docetaxel + bintrafusp alfa vs. docetaxel alone using a one-sided log-rank test.

  From randomization to the first of either disease progression or death from any cause, assessed up to 3 years and 2 months

Secondary Outcomes (4)

• Overall Survival (OS)

  From study entry to death from any cause, assessed up to 3 years and 2 months

• Confirmed Response Rates

  Up to 3 years and 2 months

• Duration of Response

  Up to 3 years and 2 months

• Incidence of Adverse Events

  Up to 3 years and 2 months

Study Arms (2)

Arm I (docetaxel, bintrafusp alfa)

EXPERIMENTAL

Patients receive docetaxel 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.

Drug: Bintrafusp Alfa; Drug: Docetaxel

Arm II (docetaxel)

ACTIVE COMPARATOR

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.

Drug: Docetaxel

Interventions

Bintrafusp Alfa DRUG

Given IV

Also known as: Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C

Arm I (docetaxel, bintrafusp alfa)

Docetaxel DRUG

Given IV

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Arm I (docetaxel, bintrafusp alfa); Arm II (docetaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Histological confirmation of non-small cell lung cancer (NSCLC) with advanced disease
• Prior treatment required:
• Anti-PD1/PD-L1 agent in combination with platinum-based chemotherapy
• Measurable disease
• NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Hemoglobin \>= 9.0 g/dL (obtained =\< 14 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 14 days prior to registration)
• Platelet count \>= 100,000/mm\^3 (obtained =\< 14 days prior to registration)
• Total bilirubin =\< upper limit of normal (ULN) (obtained =\< 14 days prior to registration)
• Alanine aminotransferase (ALT/serum glutamate pyruvate transaminase \[SGPT\]) and aspartate transaminase (AST/serum glutamic-oxaloacetic transaminase \[SGOT\]) =\< 1.5 x ULN (obtained =\< 14 days prior to registration)
• Alkaline phosphatase \<= 2.5 x ULN (obtained =\< 14 days prior to registration)
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy INR or aPTT is within target range of therapy (obtained =\< 14 days prior to registration)
• Calculated creatinine clearance \>= 30 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)

You may not qualify if:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential who are unwilling to employ adequate contraception
• Any of the following prior therapies:
• Surgery =\< 4 weeks prior to registration
• Chemotherapy =\< 4 weeks prior to registration
• Received single agent anti-PD1/PD-L1 as first line therapy for metastatic disease
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms

Interventions

bintrafusp alfa protein, human; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Konstantinos Leventakos
• Organization: Mayo Clinic

leventakos.konstantinos@mayo.edu

507-284-2511

Study Officials

• Konstantinos Leventakos, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 20, 2020
• Study Start: October 23, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2024-01

Locations

US (3)