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Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer

NCT06731413•Virginia Commonwealth University

View on ClinicalTrials.gov

Summary

Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS\<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.

Detailed Description

This is a single institution, single arm, open label phase 2 study in vulnerable or older adults (Age ≥70) with recurrent or metastatic, histologically confirmed squamous cell carcinoma or non-squamous cell carcinoma of lung without driver mutation and PD-L1 TPS \< 50% to evaluate safety and tolerability of reduced dose of chemotherapy and immunotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
•Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
•No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
•Age 70 or meeting frailty definition or above at the date of signing informed consent
•Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)
•PD-L1 tumor proportion score (TPS) of less than 50%
•Eastern Cooperative Oncology Group (ECOG) PS of 0-3
•Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
•Absolute neutrophil count (ANC) ≥ 1,000/μL
•Platelets ≥ 75,000/μL
+4 more criteria

Exclusion Criteria

•Participants with life expectancy of less than 3 months at the time of enrollment
•Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
•Diagnosis of interstitial lung disease
•Creatinine clearance of \<30 mL/min
•Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
•Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:
•* Doses less than or equal to the equivalent of prednisone 10 mg daily
•* Short courses of steroids that are discontinued prior to enrollment
•* Inhaled, intranasal and/or topical steroids
•* Dexamethasone taper for treating vasogenic edema associated with CNS disease

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

February 11, 2025

Primary Completion Date

July 30, 2030

Completion Date

July 30, 2033

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Non-Small Cell Lung CancerNSCLCAdvanced Non-Small Cell Lung CancerMetastatic Non Small Cell Lung Cancer

Interventions

Reduced Dose of Chemotherapy and Immunotherapy

DRUG

Contacts

Massey IIT Research Operations

CONTACT

804-628-6430 masseyepd@vcu.edu

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment