NSCLC Stage IVBEACON-LUNGNCT04676386
Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy
An observational study of NSCLC Stage IV and NSCLC, Stage IIIC, run by Addario Lung Cancer Medical Institute at 2 sites in United States.
Trial summary
This Observational study will explore the utility of the Biodesix, Inc. "PIR" (primary immune response) test to predict outcomes in treatment-naïve advanced stage NSCLC with PD-L1 tumor proportion score (TPS) > 50% and ECOG performance status (PS) 0-2 NSCLC patients who are treated with PD-1/PD-L1 based therapy with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC Stage IV, NSCLC, Stage IIIC
- What is being tested?
- Primary Immune Response (PIR) test by Biodesix, Inc.
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 30 Dec 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be treatment-naïve advanced NSCLC patients with PD-L1 TPS ≥50% who will receive PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin and are managed per treating physician's standard of care.
Who may be able to join
- Treatment naïve for their stage IIIC/IV AJCC 8 non-small cell lung cancer with a tumor biopsy PD-L1 TPS > 50%
- Intent to treat with PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin
- ECOG PS 0-2
- Ability to consent to participate in the study
Who cannot join
- Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Addario Lung Cancer Medical Institute (ALCMI)
San Carlos, California, 94070
About this study
This Observational study will explore the utility of the Biodesix, Inc. "PIR" (primary immune response) test to predict outcomes in treatment-naïve advanced stage NSCLC with PD-L1 tumor proportion score (TPS) > 50% and ECOG performance status (PS) 0-2 NSCLC patients who are treated with PD-1/PD-L1 based therapy with or without the addition of platinum based chemotherapy.
Read the detailed description
This is an observational, multicenter study designed to assess biomarkers (serum and plasma) as predictive of early progression in 390 treatment-naive patients with advanced stage non-small cell lung cancer (NSCLC) and PD-L1 TPS ≥50% treated with two standard of care (SOC) regimens, platinum based PD-1/PD-L1 regimen with monotherapy (single agent PD-1/PD-L1 therapy).
Prior to enrollment, tumor specimens will be tested for PD-L1 expression according to participating centers' standard operating procedures. Patients will be treated, according to physician choice, with platinum-based PD-1/PD-L1 regimen versus single agent PD-1/PD-L1 regimen. For each treatment cohort of 195 patients, enrollment will proceed in sub-cohorts to ensure a population with 20% ECOG PS2 patients and a total of 40 squamous cell carcinoma patients per treatment arm.
Patients will receive one of the following standard-of-care (SOC) treatment regimens at the discretion of the treating investigator:
- PD-1/PD-L1 therapy
- Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination
Tumor assessment will follow RECIST v1.1.
Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.
Remaining serum and plasma will be stored for subsequent exploratory studies and will be available to the investigators in the ALCMI network per ALCMI standard operating procedures.
Additionally, pathology reports including PD-L1 results and Next Generation Sequencing results, from any CLIA laboratory, will be collected.
- Conditions
- NSCLC Stage IV, NSCLC, Stage IIIC
- Being tested
- Primary Immune Response (PIR) test by Biodesix, Inc.
- 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.
Primary Immune Response (PIR) test by Biodesix, Inc.Diagnostic test
Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.
| Study group | Role | What they receive |
|---|---|---|
| PD1/PD-L1 | Standard of Care: PD1/PD-L1 monotherapy Receives: Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc. | |
| PD1/PD-L1 + chemo | Standard of Care: Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination Receives: Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker PIR evaluation
To collect biospecimens and evaluate candidate biomarkers of early progression on patients with >50% PD-L1 positive tumors treated with PD-1/PD-L1 monotherapy or PD-1/PD-L1/chemotherapy combination
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Feb 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: Recruitment futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addario Lung Cancer Medical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Biodesix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676386
- Sponsor's protocol ID
- ALCMI-014
- Acronym
- BEACON-LUNG
- Status last verified
- Feb 2024
- First submitted
- 16 Dec 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy
- ClinicalTrials.gov ID
- NCT04676386
- Acronym / sponsor ID
- BEACON-LUNG / ALCMI-014
- Conditions
- NSCLC Stage IV, NSCLC, Stage IIIC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment futility
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Addario Lung Cancer Medical InstituteUniversity, hospital or other
- Collaborators
- Biodesix, Inc.
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 21 Dec 2020 (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.
This Observational study will explore the utility of the Biodesix, Inc. "PIR" (primary immune response) test to predict outcomes in treatment-naïve advanced stage NSCLC with PD-L1 tumor proportion score (TPS) > 50% and ECOG performance status (PS) 0-2 NSCLC patients who are treated with PD-1/PD-L1 based therapy with or without the addition of platinum based chemotherapy.
Detailed description
This is an observational, multicenter study designed to assess biomarkers (serum and plasma) as predictive of early progression in 390 treatment-naive patients with advanced stage non-small cell lung cancer (NSCLC) and PD-L1 TPS ≥50% treated with two standard of care (SOC) regimens, platinum based PD-1/PD-L1 regimen with monotherapy (single agent PD-1/PD-L1 therapy).
Prior to enrollment, tumor specimens will be tested for PD-L1 expression according to participating centers' standard operating procedures. Patients will be treated, according to physician choice, with platinum-based PD-1/PD-L1 regimen versus single agent PD-1/PD-L1 regimen. For each treatment cohort of 195 patients, enrollment will proceed in sub-cohorts to ensure a population with 20% ECOG PS2 patients and a total of 40 squamous cell carcinoma patients per treatment arm.
Patients will receive one of the following standard-of-care (SOC) treatment regimens at the discretion of the treating investigator:
- PD-1/PD-L1 therapy
- Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination
Tumor assessment will follow RECIST v1.1.
Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.
Remaining serum and plasma will be stored for subsequent exploratory studies and will be available to the investigators in the ALCMI network per ALCMI standard operating procedures.
Additionally, pathology reports including PD-L1 results and Next Generation Sequencing results, from any CLIA laboratory, will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD1/PD-L1 | – | Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.Standard of Care: PD1/PD-L1 monotherapy |
| PD1/PD-L1 + chemo | – | Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.Standard of Care: Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be treatment-naïve advanced NSCLC patients with PD-L1 TPS ≥50% who will receive PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin and are managed per treating physician's standard of care.
Key inclusion criteria (4 listed)
- Treatment naïve for their stage IIIC/IV AJCC 8 non-small cell lung cancer with a tumor biopsy PD-L1 TPS > 50%
- Intent to treat with PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin
- ECOG PS 0-2
- Ability to consent to participate in the study
Key exclusion criteria (1 listed)
- Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements
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 |
|---|---|---|
| Primary Immune Response (PIR) test by Biodesix, Inc.Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively. | Diagnostic test | PD1/PD-L1, PD1/PD-L1 + chemo |
Primary outcome
Biomarker PIR evaluation
Time frame: 3 years
To collect biospecimens and evaluate candidate biomarkers of early progression on patients with >50% PD-L1 positive tumors treated with PD-1/PD-L1 monotherapy or PD-1/PD-L1/chemotherapy combination
Results and safety
The study was stopped early (reason given: Recruitment futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for NSCLC Stage IV
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC Stage IV and NSCLC, Stage IIIC, run by Addario Lung Cancer Medical Institute at 2 sites 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Recruitment futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker PIR evaluation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.