Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06071013
• Other study ID #: CMUH112-REC2-121
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 28, 2023
• Est. completion date: August 27, 2026

Study information

• Verified date: October 2023
• Source: China Medical University Hospital
• Contact: Chih-Yen Tu
• Phone: +886-975-681-007
• Email: chesttu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer

Description:

The efficacy of the regimen is evaluated by participants' progression-free survival and overall survival.

Nintedanib is a medication that blocks endothelial cells in tumor microenvironments and is effective in delaying tumor progression. Nintedanib is also a drug approved for idiopathic pulmonary fibrosis in the clinic.

The participants will take 1 nintedanib tablet after a meal twice per day with a twelve-hour interval. EGFR TKI-gefitinib, erlotinib, or afatinib will be taken 1 tablet once per day during each treatment cycle. The treatment cycle in this study is 30 days.

In this study, the participants will have a physical exam in 6 weeks and 12 weeks after the initiation of the treatment. In the 6 weeks of the study, the participants will have blood tests and a CT scan. About 5cc of blood will be collected each time. In addition, the participant's tumor will be measured by a CT scan every 12 weeks.

If the participants develop any unacceptable symptoms or changes in liver function tests, the participants' treatment may be delayed and/or the dose decreased until the symptoms are disappeared. It may even be necessary to stop your treatment. The doctor will inform the participant of any changes in the participants' treatment schedule or in the doses of medication after he/she evaluates the participants in the clinic.

After treatment ends, the participants will have a follow-up visit at the clinic. At this visit, the participants will have a complete physical exam, including blood (about 5cc) tests and CT scan to measure the size of the tumors.

This is an investigational study. Up to 20 participants will take part in this study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 27, 2026
• Est. primary completion date: August 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.

2. Positive EGFR mutations are diagenesis.

3. Participants with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, and afatinib.

4. Participants must have adequate hepatic, renal, and bone marrow function

Exclusion Criteria:

1. Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.

2. Participants have known hypertension, and chronic liver and gastrointestinal disease.

3. Participants have known brain metastasis.

4. Female participants who are pregnant or breast-feeding

5. Participants have a known diagnosis of EGFR T790M mutation.

6. Participants have a known diagnosis of negative nPKCd expression by immunohistochemistry (IHC).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation
• EGFR-TKI Resistant Mutation
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Nintedanib, gefitinib, erlotinib, afatinib
Nintedanib is a multiple tyrosine kinase inhibitor that can bind competitively to the ATP-binding pocket of these receptors and block intracellular signaling, which is critical for the proliferation and migration. Gefitinib, erlotinib and afatinib are the first- and second- generation of EGFR tyrosine kinase inhibitors that reversibly and irreversibly inhibit the binding of ATP to the phosphate-binding loop of ATP binding site in the kinase domain of EGFR, leading to the inhibition of cell proliferation and induction of apoptosis of cancer cells.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The toxicity of combinate nintedanib and EGFR TKI		Assessed every 6 weeks of chest CT scan until PD.
Primary	Patient objective response rate		Assessed every 6 weeks of chest CT scan
Secondary	Overall survival		Assessed every 12 weeks thereafter up to end of study at approximately 2 years