Neoadjuvant Immunotherapy in Advanced NSCLC

Lung Cancer, Non-small Cell Clinical Trial

Official title:

Neoadjuvant Immunotherapy in Advanced NSCLC

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05137912
• Other study ID #: e4c2e8edac362acab7123654b9e734
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2022
• Source: Power Life Sciences Inc.
• Contact: Michael B Gill
• Phone: (415) 900-4227
• Email: bask[@]withpower.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. One such example would be to evaluate either single agent or an immunotherapy combination with chemotherapy. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.

Description:

A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. [The Power Life Sciences Investigative Team](https://www.withpower.com) is running a study to evaluate either single agent or an immunotherapy combination with chemotherapy. Patients can contact a site administrator via the information below, or enroll directly via https://www.withpower.com/trial/pha se-4-2019-e67c1. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >= 18 Years of Age

• Informed consent is provided

• Histologically confirmed resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Epidermal growth factor receptor (EGFR) mutation negative and anaplastic lymphoma kinase (ALK) translocation negative

Exclusion Criteria:

• EGFR mutation positive and ALK translocation positive

• Active central nervous system (CNS) metastases

• Autoimmune diseases

• Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease

• Patients with interstitial lung disease will not be included if they have symptomatic interstitial lung disease (ILD) - Grade 3-4

• Women who are breast feeding or pregnant

• Sexually active women or men of childbearing potential who are not willing to use an effective contraceptive method during the study

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-small Cell

Intervention

Biological:
• Immunotherapy
Patients within this intervention group will be histologically confirmed to have resectable non small cell lung cancer with stage II-IIIA. Patients may receive single agent immunotherapy or immunotherapy combined with chemotherapy.

Locations

Country	Name	City	State
United States	Power Life Sciences	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Broderick SR. Adjuvant and Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer. Thorac Surg Clin. 2020 May;30(2):215-220. doi: 10.1016/j.thorsurg.2020.01.001. Review. — View Citation

Gutierrez-Sainz L, Cruz-Castellanos P, Higuera O, de Castro-Carpeño J. Neoadjuvant Chemoimmunotherapy in Patients with Resectable Non-small Cell Lung Cancer. Curr Treat Options Oncol. 2021 Aug 23;22(10):91. doi: 10.1007/s11864-021-00885-6. Review. — View Citation

Jiang L, Huang J, Jiang S, Rong W, Shen Y, Li C, Tian Y, Ning J, Chen X, Yang Y, Ding Z, Li Z, Luo Q. The surgical perspective in neoadjuvant immunotherapy for resectable non-small cell lung cancer. Cancer Immunol Immunother. 2021 Aug;70(8):2313-2321. doi: 10.1007/s00262-021-02847-1. Epub 2021 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Pathological Response	To evaluate the major pathological response (MPR) rate of participants	12 Weeks
Secondary	Objective Response Rate	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)	12 Weeks
Secondary	MPR based on diverse PD-L1 expression	Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants	12 Weeks
Secondary	Progression Free Survival	Progression Free Survival (PFS)	12 Weeks