Clinical trial NCT06071013: Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Official title: A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
EGFR Gene Mutation
EGFR-TKI Resistant Mutation
Keywords: nPKC delta
Angiogenesis
EGFR TKI drug resistant
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, Taiwan
First posted: 2023-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed 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, afatinib, or osimertinib 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.

Eligibility criteria: 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, afatinib, or osimertinib.
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 negative nPKCδ expression by immunohistochemistry (IHC).

Primary outcomes:
measure: The toxicity of combinate nintedanib and EGFR TKI
timeFrame: Assessed every 6 weeks of chest CT scan until PD.
measure: Patient objective response rate
timeFrame: Assessed every 6 weeks of chest CT scan
Secondary outcomes:
measure: Overall survival
timeFrame: Assessed every 12 weeks thereafter up to end of study at approximately 2 years
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Pulmonary Medicine
role: STUDY_DIRECTOR
References: