Lung Cancer, Non-small CellNCT05137912
Neoadjuvant Immunotherapy in Advanced NSCLC
An observational study of Lung Cancer, Non-small Cell, run by Power Life Sciences Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell
- What is being tested?
- Immunotherapy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Stage IIA-IIIA NSCLC
Who may be able to join
- >= 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Patient Support contact
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
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.
Read the detailed 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 <a href="https://www.withpower.com/trial/phase-4-2019-e67c1">https://www.withpower.com/trial/phase-4-2019-e67c1</a>. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.
- Conditions
- Lung Cancer, Non-small Cell
- Being tested
- Immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response
To evaluate the major pathological response (MPR) rate of participants
Measured: 12 Weeks
Secondary outcomes (3)
Objective Response Rate
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 12 Weeks
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
Measured: 12 Weeks
Progression Free Survival
Progression Free Survival (PFS)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, [Power Life Sciences Inc.](www.withpower.com)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137912
- Sponsor's protocol ID
- e4c2e8edac362acab7123654b9e734
- Status last verified
- Jan 2022
- First submitted
- 16 Nov 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33512555Broderick 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.
PubMed 32327180Gutierrez-Sainz L, Cruz-Castellanos P, Higuera O, de Castro-Carpeno 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.
PubMed 34424417
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunotherapy in Advanced NSCLC
- ClinicalTrials.gov ID
- NCT05137912
- Acronym / sponsor ID
- e4c2e8edac362acab7123654b9e734
- Conditions
- Lung Cancer, Non-small Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 <a href="https://www.withpower.com/trial/phase-4-2019-e67c1">https://www.withpower.com/trial/phase-4-2019-e67c1</a>. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stage IIA-IIIA NSCLC
Key inclusion criteria (5 listed)
- >= 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapyPatients 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. | Biological | – |
Primary outcome
Major Pathological Response
Time frame: 12 Weeks
To evaluate the major pathological response (MPR) rate of participants
3 secondary outcomes
Objective Response Rate
Time frame: 12 Weeks
MPR based on diverse PD-L1 expression
Time frame: 12 Weeks
Progression Free Survival
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 33512555Jiang 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.
- Background: PubMed 32327180Broderick 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.
- Background: PubMed 34424417Gutierrez-Sainz L, Cruz-Castellanos P, Higuera O, de Castro-Carpeno 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.
- Participating Patient Terms of ServiceLink provided by the sponsor.
- Immunotherapy As Neoadjuvant Therapy For Non Small Cell Lung CancerLink provided by the sponsor.
- Patient Support LineLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patient Support contact
Michael B Gill study director
[Power Life Sciences Inc.](www.withpower.com)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Non-small Cell, run by Power Life Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill ((415) 900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.